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TREATMENT MONITORING WITH THE AGILE 3+ SCORE IN PATIENTS WITH METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS: ANALYSIS OF DATA FROM A RANDOMISED PLACEBO-CONTROLLED TRIAL OF SEMAGLUTIDE

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Introduction

There is an unmet need to evaluate non-invasive biomarkers for monitoring and predicting change in fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH) who are receiving treatment. Several biomarkers have been validated for grading and staging in MASH, including the Agile 3+ score, which can identify advanced fibrosis in non-alcoholic fatty liver disease. Agile 3+ was applied to patients enrolled in a clinical trial of semaglutide to investigate the score’s ability to monitor treatment effect and to predict change in fibrosis stage.

Aims & Methods

Data were from a phase 2b study in which patients with MASH and fibrosis stage 1–3 were randomised to 72 weeks’ treatment with subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, once daily (NCT02970942). For this analysis, Agile 3+ scores were calculated at baseline and weeks 28, 52 and 72 using liver stiffness measurements (LSM) from vibration-controlled transient elastography (VCTE) (where available), alanine- and aspartate aminotransferase levels, platelet count, age, sex and diabetes status. A mixed model for repeated measures was used to assess treatment effect on Agile 3+ (missing values were not imputed) during the on-treatment period. Change from baseline in Agile 3+ at weeks 28, 52 and 72 and its association with histological fibrosis improvement at week 72 in the 0.4 mg semaglutide and placebo arms was examined using logistic regression with an interaction effect between relative change in Agile 3+ and treatment. Odds ratios (OR) for improvement in fibrosis of ≥1 stage at week 72 associated with a 0.5-fold change in Agile 3+ at each time point were calculated.

Results

The numbers of patients with Agile 3+ data at baseline and weeks 28, 52 and 72 were 208, 210, 209 and 203, respectively. Mean baseline Agile 3+ (standard deviation) was 0.50 (0.28), 0.61 (0.27) and 0.55 (0.30) for semaglutide 0.1, 0.2 and 0.4 mg, respectively, and 0.46 (0.30) for placebo. Agile 3+ was significantly reduced with semaglutide 0.4 mg vs placebo at weeks 28 (estimated treatment ratio 0.64 [95% confidence interval (CI) 0.48; 0.87]; p=0.004), 52 (0.63 [0.48; 0.83]; p=0.001) and 72 (0.59 [0.41; 0.85]; p=0.005). In the placebo group, associations between a decrease in Agile 3+ at weeks 28 and 52 and improvement in fibrosis at week 72 were significant (OR [95% CI] 4.10 [1.50; 11.19]; p=0.006 and 3.71 [1.28; 10.75]; p=0.016, respectively). A similar trend was seen in the semaglutide 0.4 mg group, but this did not reach significance. For changes in Agile 3+ at week 72, the trend did not reach significance for either the placebo or semaglutide groups. Although this analysis is limited by patient drop-out during the study, the results indicate that changes in Agile 3+ as early as week 28 may be predictive of histological changes at week 72.

Conclusion

Semaglutide demonstrated a significant treatment effect on Agile 3+, with change in Agile 3+ partially predicting histological outcomes, irrespective of treatment allocation. A decrease in Agile 3+ was associated with an improvement in histological fibrosis.

Disclosure

Funding: Novo Nordisk A/S

Medical writing: The authors acknowledge the medical writing assistance of Stephen Purver MChem and Sophie Bruce of OPEN Health Communications, and funded by Novo Nordisk A/S, in accordance with Good Publication Practice (GPP) guidelines (www.ismpp.org/gpp-2022).
Laurent Castéra has received consulting fees from Echosens, Novo Nordisk, Madrigal, MSD, Pfizer, Sagimet and speaker honorarium from Echosens and Novo Nordisk.
Jörn M. Schattenberg has received consulting fees from Apollo Endosurgery, Aged diagnostics, Bayer, Boehringer Ingelheim, Gilead Sciences, GSK, Intercept Pharmaceuticals, Inventiva Pharma, Ipsen, Madrigal, MSD, Northsea Therapeutics, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Siemens Healthineers; research funding from Boehringer Ingelheim, Gilead Sciences, Siemens Healthcare GmbH; and speaker honorarium from Boehringer Ingelheim, Echosens, Histoindex, Madrigal Pharmaceuticals, MedPublico GmbH, Novo Nordisk.
Céline Fournier-Poizat, Julie Foucquier, Véronique Miette and Laurent Sandrin are employees of Echosens. Echosens received research funding for this study from Novo Nordisk.
Mette Skalshøi Kjær, Niels Krarup, Sune Boris Nygård and Ahsan Shoeb Patel are employees of Novo Nordisk A/S. MSK is also a shareholder of Novo Nordisk A/S.
Encore statement: This abstract was also presented at the European Association for the Study of the Liver (EASL) Congress, 21–24 June 2023 in Vienna, Austria.

TREATMENT MONITORING WITH THE AGILE 3+ SCORE IN PATIENTS WITH METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS: ANALYSIS OF DATA FROM A RANDOMISED PLACEBO-CONTROLLED TRIAL OF SEMAGLUTIDE

Laurent Castera 1, Céline Fournier-Poizat 2, Julie Foucquier 2, Mette Skalshøi Kjær 3, Niels Krarup 3, Véronique Miette 2, Sune Boris Nygård 3, Ahsan Shoeb Patel 3, Laurent Sandrin 2, Jörn Schattenberg 4

1 Department of Hepatology, Beaujon Hospital, Université Paris Cité, Clichy, France

2 Echosens, Paris, France

3 Novo Nordisk A/S, Søborg, Denmark

4 Metabolic Liver Research Program, University Medical Center Mainz, Mainz, Germany

Event

UEG Week Vienna 2024

Topics

Hepatobiliary

Submission format

Abstract

Session

Recent break throughs in treating and monitoring MASH

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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WEIGHT-INDEPENDENT BENEFITS OF SEMAGLUTIDE ON HISTOLOGY AND NON-INVASIVE TESTS IN PARTICIPANTS WITH BIOPSY-DEFINED METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS: POST HOC ANALYSIS OF THE ESSENCE TRIAL PART 1

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Introduction

The ongoing phase 3 ESSENCE trial (NCT04822181) reported positive results for histological and non-invasive test (NIT) endpoints in an interim analysis of the first 800 randomised participants with biopsy-defined metabolic dysfunction-associated steatohepatitis (MASH) and F2/F3 fibrosis receiving once-weekly subcutaneous semaglutide 2.4 mg vs placebo. Participants receiving semaglutide achieved a mean weight loss of 10.5% vs 2.0% with placebo. In this post hoc analysis, we assessed the weight dependency of the effects of semaglutide 2.4 mg on study endpoints (NITs and histology) after 72 weeks of treatment, using weight loss-independent and weight loss-dependent pathways as covariates.

Aims & Methods

NITs and biopsies were assessed at baseline and week 72. MASH-related NIT responder endpoints were change in alanine aminotransferase (ALT; ≥17-unit reduction) and FibroScan-aspartate aminotransferase (FAST) score (≥0.22 reduction). Fibrosis-related NIT responder endpoints were change in vibration-controlled transient elastography (VCTE) liver stiffness measurement (30% reduction) and Enhanced Liver Fibrosis (ELF) score (≥0.5-unit reduction). Histological endpoints included resolution of MASH and improvement in fibrosis. All endpoints were assessed using logistic regression at week 72 with treatment as exposure, percentage weight loss from baseline to week 72 as mediator, and baseline type 2 diabetes status, fibrosis stage and body weight as covariates. The total and weight loss-independent and weight loss-dependent effect sizes were calculated as odds ratios (ORs), and missing data were omitted. All data are based on the full analysis set from the on-treatment observation period.

Results

For MASH-related endpoints, the total effect (OR [95% confidence interval (CI)]) for ALT, FAST score and resolution of MASH without worsening of fibrosis was 4.7 (3.3, 6.6), 6.9 (4.3, 10.9) and 3.9 (2.8, 5.5), respectively. ORs (95% CI) for the weight loss-independent effect were 3.0 (2.0, 4.6), 2.8 (1.7, 4.7) and 2.0 (1.4, 3.0), respectively; for the weight loss-dependent effect, ORs (95% CI) were 1.5 (1.2, 2.0), 2.5 (1.8, 3.4) and 1.9 (1.6, 2.4), respectively. Overall, 71.9%, 53.3% and 51.9% of the total effect for ALT, FAST score and resolution of MASH, respectively, were not mediated by weight loss. For the fibrosis-related endpoints, the total effect (OR [95% CI]) for VCTE, ELF score and improvement in fibrosis without worsening of MASH were 3.0 (2.0, 4.4), 4.5 (3.1, 6.4) and 2.1 (1.5, 3.1), respectively. ORs (95% CI) for the weight loss-independent effect were 1.7 (1.1, 2.7), 2.4 (1.6, 3.7) and 1.5 (1.0, 2.4), respectively; for the weight loss-dependent effect, ORs (95% CI) were 1.7 (1.4, 2.2), 1.9 (1.5, 2.3) and 1.4 (1.1, 1.8), respectively. This shows that 48.9%, 58.5% and 55.5% of the total effect for VCTE, ELF score and fibrosis improvement, respectively, were not mediated by weight loss.

Conclusion

Semaglutide 2.4 mg improved MASH-related histological and NIT endpoints and fibrosis-related NIT endpoints through equal contributions of weight loss-independent and weight loss-dependent metabolic mechanisms, with effects beyond weight loss.

Disclosure

Philip N. Newsome reports grants from Novo Nordisk, and has received consulting fees from Boehringer Ingelheim, Madrigal and Novo Nordisk. PNN also reports honoraria as a speaker from AiCME, Echosens and Novo Nordisk; support for attending meetings for Novo Nordisk; and participation on an advisory board for Boehringer Ingelheim, GSK, Madrigal, Novo Nordisk and Sagimet.
Elisabetta Bugianesi served as a consultant or advisory board member for Boehringer Ingelheim, Gilead, Intercept, Merck, Novo Nordisk, Pfizer and ProSciento, and as a speaker for Gilead, Intercept, Merck, Novo Nordisk and Pfizer. EB has also received a research grant from Gilead for fatty liver research.
Vlad Ratziu received consulting fees from Boehringer Ingelheim, GSK, Madrigal, Novo Nordisk, ProSciento and Sagimet, and research grants (to institution) from MSD.
Mary E. Rinella consults for 89bio, Akero, Boehringer Ingelheim, CytoDyn, GSK, HistoIndex, Intercept, Madrigal, NGM Bio, Novo Nordisk, Sagimet and Sonic Incytes. MER has received fees for consulting or participation in advisory boards for Boehringer Ingelheim, Echosens, Eli Lilly and Novo Nordisk. MER also reports honoraria as a speaker for CME events sponsored by Boehringer Ingelheim, Madrigal and Novo Nordisk.
Michael Roden received lecture fees or served on advisory boards for AstraZeneca, Echosens, Eli Lilly, Madrigal, Merck-MSD, Novo Nordisk and Target RWE, and performed investigator-initiated research with support from Boehringer Ingelheim, Novo Nordisk and Nutricia/Danone to the German Diabetes Center.
Arun J. Sanyal consults for and advises AstraZeneca and Avant Santé. AJS also consults for and has received grants from Akero, BMS, Eli Lilly, Intercept, Madrigal and Novo Nordisk. AJS consults for and owns stock in Rivus, and consults for 89bio, AGED Diagnostics, Albireo, Alnylam, Altimmune, Boehringer Ingelheim, Echosens, Genentech, Gilead, GSK, HistoIndex, Mallinckrodt, Merck, NGM Bio, Novartis, PathAI, Pfizer, Poxel, Regeneron Pharmaceuticals, Inc., Salix, Siemens, Surrozen, Takeda, Terns and Zydus. AJS owns stock in Durect, Exalenz, Genfit, Indalo, Inversago and Tiziana, and has received royalties from Elsevier and Wolters Kluwer.
Adel Belloum, Niels Krarup, Anna Cali, Mohamed Tawfik and Thea Vestergaard are employees and stockholders of Novo Nordisk A/S.
Jörn M. Schattenberg declares consultant honoraria from 89bio, Alentis, Alexion, Altimmune, AstraZeneca, Bionorica, Boehringer Ingelheim, Gilead Sciences, GSK, Inventiva Pharma, Ipsen, Eli Lilly, Madrigal Pharmaceuticals, MSD, Northsea Therapeutics, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi and Siemens Healthineers; speaker honoraria from AbbVie, Academic Medical Education, Boehringer Ingelheim, Echosens, Forum für Medizinische Fortbildung, Gilead Sciences, Madrigal Pharmaceuticals, MedicalTribune, MedPublico GmbH, MedScape and Novo Nordisk; and stockholder options in AGED Diagnostics and Hepta Bio.
Matthew J. Armstrong reports investigator fees from Novo Nordisk.
Anja Geerts reports no conflicts of interest.
Jacob George is supported by the Robert W. Storr Bequest to the Sydney Medical Foundation, University of Sydney; a National Health and Medical Research Council of Australia Program Grant (APP1053206), Project, Ideas and Investigator grants (APP2001692, APP1107178, APP1108422, APP1196492) and a Cancer Institute, NSW grant (2021/ATRG2028). He serves on advisory boards for AbbVie, AstraZeneca, Boehringer Ingelheim, Novo Nordisk and Roche.
Chun-Jen Liu reports no conflicts of interest.
Ewa Janczewska was involved in clinical trials and lectures with Novo Nordisk, was involved in clinical trials with Inventiva Pharma, MSD, Galectin, Dr Falk and Sanofi and reports travel grants from Novo Nordisk and Eli Lilly.
Håvard Midgard is involved in lectures with Novo Nordisk, AbbVie and Gilead, and reports ad boards for Boeringer Ingelheim, AbbVie and Gilead.
Igor Bakulin reports involvement in clinical trials for Novo Nordisk and Eli Lilly and lectures for AbbVie and Johnson & Johnson.

WEIGHT-INDEPENDENT BENEFITS OF SEMAGLUTIDE ON HISTOLOGY AND NON-INVASIVE TESTS IN PARTICIPANTS WITH BIOPSY-DEFINED METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS: POST HOC ANALYSIS OF THE ESSENCE TRIAL PART 1

Philip Newsome 1, Matthew Armstrong 2, Igor Bakulin 3, Adel Belloum 4, Anna M.G. Cali 4, Unknown Unknown 5, Jacob George 6, Unknown Unknown 7, Niels Krarup 4, Chun-Jen Liu 8, Håvard Midgard 9, Vlad Ratziu 10, Mary Rinella 11, Michael Roden 12, Arun Sanyal 13, Jörn Schattenberg 14, Mohamed Tawfik 4, Thea Cæcilie Vestergaard 4, Elisabetta Bugianesi 15

1 Roger Williams Institute of Liver Studies, Faculty of Life Sciences and Medicine, King’s College London, Foundation for Liver Research and King’s College Hospital, London, United Kingdom|||College of Medical and Health, University of Birmingham, Birmingha

2 Liver Unit, Queen Elizabeth Hospital Birmingham and NIHR Biomedical Research Centre, University of Birmingham, Birmingham, United Kingdom

3 Mechnikov North-Western State Medical University, Saint Petersburg, Russian Federation

4 Novo Nordisk A/S, Bagsværd, Denmark

5 Department of Gastroenterology & Hepatology, University Hospital Ghent, Ghent, Belgium|||Faculty of Medicine and Health Sciences, University of Ghent, Ghent, Belgium

6 Storr Liver Centre, The Westmead Institute for Medical Research, Westmead Hospital, New South Wales, Australia

7 Hepatology Outpatient Clinic, ID Clinic, Mysłowice, Poland

8 Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan, Province of China|||Hepatitis Research Center and Clinical Trial Center, National Taiwan University Hospital, Taipei, Taiwan, Province of China

9 Department of Gastroenterology, Oslo University Hospital, Oslo, Norway

10 Institute of Cardiometabolism and Nutrition, INSERM UMRS 1138 CRC, Hospital Pitié Salpêtrière (ICAN), Sorbonne Université, Paris, France

11 Division of Gastroenterology, Hepatology and Nutrition, University of Chicago, Chicago, United States

12 Department of Endocrinology and Diabetology, Medical Faculty and University Hospital of Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany|||Institute for Clinical Diabetology, German Diabetes Center, Leibniz Center for Diabetes Researc

13 Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University School of Medicine, Richmond, United States

14 Department of Internal Medicine II, Saarland University Medical Center, Homburg, Germany

15 Department of Medical Sciences, University of Turin, Torino, Italy

Event

UEG Week Berlin 2025

Topics

Hepatobiliary

Submission format

Abstract

Session

Lifestyle management and therapy in MASLD

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

Standard Poster

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Introduction

Semaglutide, a glucagon-like peptide-1 receptor analogue approved for treatment of type 2 diabetes (T2D) and overweight or obesity, is being investigated as a potential treatment for patients with metabolic dysfunction-associated steatohepatitis (MASH). Here, we present safety data from two phase 2 trials of subcutaneous semaglutide in patients with MASH with or without compensated cirrhosis.

Aims & Methods

This was a post-hoc analysis of two trials: NCT02970942 (320 patients with fibrosis stage F1–3 randomised 3:1 to once-daily semaglutide 0.1, 0.2 or 0.4 mg [n=80, 78 and 82] or placebo [n=80] for 72 weeks) and NCT03987451 (71 patients with compensated cirrhosis randomised 2:1 to once-weekly semaglutide 2.4 mg [n=47] or placebo [n=24] for 48 weeks). Patients received diet/lifestyle advice in both trials. Safety data were analysed descriptively.

Results

In NCT02970942, 18 patients discontinued semaglutide due to adverse events (AEs), with a similar proportion of patients discontinuing in the semaglutide 0.4 mg (5%; 4/82) and placebo arms (5%; 4/80). In NCT03987451, three patients from the semaglutide arm (6.4%) discontinued due to AEs. In both trials, gastrointestinal (GI) disorders were the most common AEs with semaglutide (64–77% vs 33–45% with placebo); most GI AEs with semaglutide were non-serious and mild (55–71%) or moderate (22–36%). The proportion of patients with GI AEs with semaglutide in the MASH trials (63.8–76.9%) was similar to that seen in the weight management program STEP (63.5–82.8%), but higher than in the T2D development program SUSTAIN (34.4–52.0%).
There were no reported cases of acute pancreatitis. Overall, the proportion of patients with hepatic AEs (most frequently reported [in 0–3 patients per arm]: blood bilirubin increased, alanine transaminase increased, hepatic enzyme increased, international normalised ratio increased, transaminases increased, ascites) was 8–11% with semaglutide versus 4–14% with placebo. Few gallbladder-related AEs were reported. Four cholelithiasis events occurred in the semaglutide arms in the two trials; three were serious, of which two led to cholecystitis or cholangitis. All three serious events resolved with cholecystectomy. No cases of drug induced liver injury were reported. Throughout the trials (up to 72 weeks), three patients in the semaglutide group reported malignant neoplasms (breast cancer, endometrial adenocarcinoma and peripheral T-cell lymphoma) vs none with placebo; all events were judged as unlikely to be related to semaglutide.

Conclusion

Data from two phase 2 trials indicate that semaglutide is generally well tolerated in patients with MASH, including those with compensated cirrhosis. No new safety concerns were identified, and the safety profile was similar to that in patients with T2D and overweight/obesity. Data from the ongoing phase 3 trial (NCT04822181) will provide further knowledge about the safety of semaglutide in patients with MASH.

Disclosure

Funding: Novo Nordisk A/S.

Medical writing: Diana Marouco, PhD, of OPEN Health Communications, provided medical writing support, which was funded by Novo Nordisk A/S in accordance with Good Publication Practice (GPP) guidelines (www.ismpp.org/gpp-2022).
Lise Lotte Gluud is scientific advisor and consultant for Alexion, Becton Dickinson, Gilead, Norgine, Novo Nordisk, Pfizer, Sobi and Vingmed.
Philip N Newsome has received grants from Boehringer Ingelheim and Novo Nordisk and is a consultant for Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, Gilead, Glaxo SmithKline, Intercept Pharmaceuticals, Novo Nordisk, Pfizer, Poxel Pharmaceuticals, Sagimet Terns and Theratechnologies.
Stephen A. Harrison is scientific advisor and consultant for Novo Nordisk.
Mette Skalshøi Kjær is a full-time employee and shareholder of Novo Nordisk A/S.
Maximilian Kurt Jara, Amine Lotfi, Karina Phonekeo and Mads Sundby Palle are full-time employees of Novo Nordisk A/S.
Encore statement: This abstract was also presented at the European Association for the Study of the Liver (EASL) Congress, 21–24 June 2023 in Milan, Italy.

SAFETY PROFILE OF SEMAGLUTIDE IN PATIENTS WITH METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS: POST-HOC ANALYSIS OF DATA FROM TWO PHASE 2 STUDIES

Lise Lotte Gluud 1, Stephen A. Harrison 2, Maximilian Kurt Jara 3, Mette Skalshøi Kjær 4, Amine Lotfi 4, Karina Phonekeo 4, Mads Sundby Palle 4, Philip Newsome 5, Kwabena Opuni 4

1 The Gastro Unit, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark

2 Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom

3 Novo Nordisk Inc., Plainsboro, United States

4 Novo Nordisk A/S, Søborg, Denmark

5 Centre for Liver and Gastrointestinal Research, Institute of Immunology and Inflammation, and National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, The Medical School, University of Birmingham, Birmingham, United Kingdom

Conference

UEG Week Vienna 2024

Topics

Hepatobiliary

Submission format

Abstract

Session

Advances in MASLD (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Introduction

Cardiovascular (CV) risk is increased in people living with metabolic dysfunction-associated steatohepatitis (MASH). Although liver biopsy remains the gold standard to diagnose MASH, it is not practical to implement on a large scale. However, non-invasive tests, such as the Fibrosis-4 score (FIB-4), are useful for staging patients with fibrotic MASH and predict overall, CV- and liver-related mortality. In the SELECT CV outcome trial, which included patients with a body mass index ≥27.0 kg/m2 and established CV disease but without diabetes, those treated with the glucagon-like peptide-1 receptor agonist semaglutide had a 20% CV risk reduction compared with those receiving placebo. We examined the CV benefits of semaglutide in a subgroup of participants at high risk of MASH as defined by FIB-4.

Aims & Methods

SELECT was a multicentre, randomised, double-blind, placebo-controlled, event-driven trial that enrolled 17,604 patients aged ≥45 years. Patients were randomly assigned in a 1:1 ratio to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo in addition to standard of care recommendations for CV disease prevention. This subgroup analysis for the primary composite endpoint of 3-point major adverse cardiovascular event (MACE; non-fatal myocardial infarction, non-fatal stroke, CV death) was performed for patients with increased MASH risk as indicated by FIB-4 ≥1.3 for patients aged <65 years and FIB-4 ≥2.0 for patients aged ≥65 years, and for a second subgroup of patients of any age with FIB-4 >2.67, respectively. As identified by review of medical history and co-medication, patients with a cause of liver disease other than MASH were not included in this analysis.

Results

From the SELECT cohort, 3,665 patients (20.8% of all) aged <65 years with FIB-4 ≥1.3 and aged ≥65 years with FIB-4 ≥2.0 were included in this analysis. The primary CV endpoint occurred in 140 of the 1,834 patients (7.6%) in the semaglutide group and in 176 of the 1,831 patients (9.6%) in the placebo group (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.63, 0.98; p < 0.03). In the subgroup of 475 patients with suspected MASH and advanced fibrosis (FIB-4 >2.67 irrespective of age), there were 22 CV events in 235 patients treated with semaglutide 2.4 mg compared with 35 events in 240 placebo-treated patients, yielding an HR of 0.64 (95% CI 0.37, 1.08; p = 0.10).

Conclusion

In line with the primary analysis of the SELECT trial, use of semaglutide 2.4 mg in a subgroup of patients at high risk of fibrotic MASH as defined by FIB-4 produced a 21% reduction in MACE outcomes.

Disclosure

SM received consulting honoraria from Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Daichii-Sankyo, esanum, Gilead, Ipsen, Lilly, Novartis, Novo Nordisk, Sandoz, Sanofi.
CB reports grants and personal fees from Amgen, Regeneron and Sanofi, and personal fees from Abbott, Akcea, AstraZeneca, Bristol Myers Squibb, Genfit, Gilead, Eli Lilly and Company, Merck (MSD) and Novo Nordisk.
CC served as advisory board for Novo Nordisk and reports having received research grants from Eli-Lilly, Novo Nordisk, Merck, Boehringer Ingelheim, Eurofarma, Fractyl, and EMS.
HC served on advisory panels for Novo Nordisk and Bayer; receiving research funding from Sanofi, Roche and IQVIA, and grants from Chief Scientist Office, Diabetes UK, European Commission, Juvenile Diabetes Research Foundation and Medical Research Council; serving on speaker’s bureau for Novo Nordisk; and holding stock in Roche Pharmaceuticals and Bayer.
AKDH, IK and ML are employees and stockholders of Novo Nordisk A/S.
ML declares having received honoraria from Akebia, Alnylam, Ardelyx, Becton Dickson, Brainstorm Cell, Eli Lilly, Endologix, FibroGen, GSK, Intarcia, Medtronic, Neovasc, Novo Nordisk, Provention Bio and ReCor, and for consulting activities and research funding to his institution from AbbVie, AstraZeneca, CSL Behring, Eli Lilly, Esperion and Novartis.
IL declares having received research grants from Boehringer Ingelheim, Merck, Mylan Pharmaceuticals Inc., Novo Nordisk, Pfizer and Sanofi US Services Inc., and has served as a consultant for AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Biomea Fusion, Boehringer Ingelheim, Carmot, Eli Lilly, Intarcia, Intercept Pharmaceuticals Inc., Janssen Global Services, LLC, Johnson & Johnson Medical Devices & Diagnostics Group - Latin America, L.L.C., MannKind Corporation, Merck, Novo Nordisk, Pfizer Inc., Sanofi US Services Inc., Shionogi Inc., Structure Therapeutics, Target pharma, Valeritas Inc., and Zealand Pharma A/S, and has received travel expenses from Boehringer Ingelheim, Eli Lilly and Company, Johnson & Johnson Medical Devices & Diagnostics Group - Latin America, L.L.C., Novo Nordisk, Sanofi US Services Inc. and Zealand Pharma A/S.
PN reports grants from Novo Nordisk, and has received consulting fees from Novo Nordisk, Boehringer Ingelheim, Gilead, Intercept, Poxel Pharmaceuticals, Bristol Myers Squibb (BMS), Pfizer, Sun Pharma, Madrigal and GSK. PNN also reports honoraria as a speaker for Novo Nordisk and AiCME; support for attending meetings for Novo Nordisk; and participation on an advisory board for Novo Nordisk, Boehringer Ingelheim, Gilead, Intercept, Poxel Pharmaceuticals, BMS, Pfizer, Sun Pharma, Madrigal and GSK.
SN received research support from AstraZeneca, Amgen, Anthera, CSL Behring, Cerenis, Cyclarity, Eli Lilly, Esperion, Resverlogix, New Amsterdam Pharma, Novartis, InfraReDx and Sanofi-Regeneron and is also a consultant for Amgen, Akcea, AstraZeneca, Boehringer Ingelheim, CSL Behring, Eli Lilly, Esperion, Kowa, Merck, Takeda, Pfizer, Sanofi- Regeneron, Vaxxinity, CSL Sequiris, and Novo Nordisk.
MQP is an employee and stockholder of Novo Nordisk A/S.
FS worked as a consultant, participated in studies, and/or received travel funds from the following companies that are involved with obesity, lipodystrophy and/or diabetes: Aegerion/Amryt, Novo Nordisk, Lilly, Bruno Pharma, Boehringer, Pfizer, BioItalia.
AJS consults for and advises Avant Santé and AstraZeneca. AJS also consults for and has received grants from Akero, BMS, Intercept, Eli Lilly, Madrigal and Novo Nordisk. AJS consults for and owns stock in Rivus, and also consults for AGED Diagnostics, Albireo, Alnylam, Altimmune, Boehringer Ingelheim, 89Bio, Echosens, Genentech, Gilead, GSK, HistoIndex, Mallinckrodt , Merck, NGM Bio, Novartis, PathAI, Pfizer, Poxel, Regeneron, Salix, Siemens, Surrozen, Takeda, Terns and Zydus. AJS owns stock in Durect, Exalenz, Genfit, Indalo, Inversago and Tiziana, and has received royalties from Elsevier and Wolters Kluwer.
SK, for the period over which SELECT was conducted, declares receiving advisory board/consulting fees from AltPep, Bayer, Boehringer Ingelheim, Casma Therapeutics, Eli Lilly, Intarcia, Merck, Novo Nordisk, Oramed, Pfizer and Third Rock Ventures.

SEMAGLUTIDE IMPROVES CARDIOVASCULAR OUTCOMES IN PATIENTS WITH HIGH RISK FOR METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS – A SUBGROUP ANALYSIS FROM THE SELECT TRIAL

Sebastian Meyhöfer 1, Cariou Bertrand 2, Cintia Cercato 3, Helen Colhoun 4, Anne Katrine Duun-Henriksen 5, Iris Kliers 5, Michael Lincoff 6, Ildiko Lingvay 7, Michelle Long 8, Philip Newsome 9, Stephen Nicholls 10, Maria Quiroga Pelaez 5, Ferruccio Santini 11, Arun Sanyal 12, Steven Kahn 13, Bernhard Ludvik 14

1 Clinical, Medical & Regulatory, Novo Nordisk Pharma GmbH, Mainz, Germany, Mainz, Germany|||Department of Internal Medicine 1 - Endocrinology & Diabetes, University Medical Centre Lübeck, Lübeck, Germany

2 Nantes Université, CHU Nantes, CNRS, INSERM, l’institut du thorax, Nantes, France, Nantes, France

3 Obesity Unit, Department of Endocrinology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil

4 Institute of Genetics and Cancer, The University of Edinburgh, Edinburgh, United Kingdom

5 Novo Nordisk A/S, Copenhagen, Denmark

6 Department of Cardiovascular Medicine, Cleveland Clinic and Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, United States

7 Department of Internal Medicine/Endocrinology and Peter O’Donnell Jr. School of Public Health, University of Texas Southwestern Medical Center, Dallas, United States

8 Novo Nordisk A/S, Copenhagen, Denmark|||Department of Medicine, Section of Gastroenterology, Boston University Chobanian & Avedisian School of Medicine, Boston, United States

9 Institute of Hepatology, King’s College London and King’s College Hospital, London, United Kingdom

10 Victorian Heart Institute, Monash University, Melbourne, Australia

11 Obesity and Lipodystrophy Centre, University Hospital of Pisa, Pisa, Italy

12 Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, United States

13 Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, United States

14 1st Medical Department and Karl Landsteiner Institute for Obesity and Metabolic Disorders, Vienna, Austria

Conference

UEG Week Vienna 2024

Topics

Hepatobiliary

Submission format

Abstract

Session

Advances in MASLD (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Introduction

ESSENCE (NCT04822181) is an ongoing 247-week Phase 3, randomised, placebo-controlled trial evaluating the effect of the glucagon-like peptide-1 analogue, semaglutide 2.4 mg subcutaneous once weekly (OW) in participants with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH). We report the baseline characteristics of the randomised participants.

Aims & Methods

Following a 14-week screening phase, 800 participants (part 1) of 1200 planned (part 2) with MASH and fibrosis stages 2/3 (F2/F3) were randomised 2:1 to receive semaglutide 2.4 mg subcutaneous OW or placebo OW added to standard of care. In part 1, the two primary endpoints at 72 weeks are resolution of steatohepatitis and no worsening of liver fibrosis, and improvement in liver fibrosis and no worsening of steatohepatitis. Based on a central pathologist evaluation, inclusion criteria were histological presence of steatohepatitis stages F2/F3 per the Nonalcoholic Steatohepatitis Clinical Research Network classification, and a non-alcoholic fatty liver disease activity score (NAS) of ≥ 4, with a score of ≥ 1 in steatosis, lobular inflammation and hepatocyte ballooning.

Results

800 participants (250 F2; 550 F3) were randomised. Mean (SD) age was 56 (11.6) years; 57.1% were female; ≥ 99% had ≥ 1 cardiometabolic risk factor(s) in accordance with the metabolic dysfunction-associated steatotic liver disease (MASLD) definition. Mean (SD) NAS was 5.05 (0.95), and higher in F3 versus F2 (5.11 [0.95] vs 4.92 [0.93], respectively). Notably, participants with a higher NAS had more cardiometabolic risk factors for MASLD (52.9% with NAS ≥ 5 vs 45.3% with NAS 4). Similarly, a greater proportion of participants with F3 had all five cardiometabolic risk factors versus F2 (52.9% vs 44.8%, respectively). Although cardiometabolic comorbidities were highly prevalent, 44.5% of participants did not have type 2 diabetes (T2D), and 27.3% did not have obesity. Normal liver transaminases were observed in 26.3% of participants (28% F2; 26% F3). Mean (SD) FibroScan liver stiffness was 12.8 (6.9) kPa, and values of < 8 kPa were observed in 15.3% of participants. Mean (SD) controlled attenuation parameter value was 329 (46) dB/m; mean (SD) enhanced liver fibrosis (ELF) score was 10.0 (1.0), and 43.5% of participants had an ELF score of < 9.8. Overall, 8.8% and 9.0% of participants with/without T2D did not meet any of the following non-invasive criteria: Fibrosis-4 index ≥ 1.3, vibration-controlled transient elastography ≥ 8.1, or ELF ≥ 9.8, and more participants with F2 (14.7–16.4%) did not meet these criteria versus F3 (4.5–6.7%).

Conclusion

The ESSENCE baseline population includes participants with significant fibrosis (F2 and F3) and approximately 91% of the trial population had ≥ 1 positive diagnostic non-invasive test. Cardiometabolic risk factors were found in ≥ 99% of participants, and in increased numbers in those with higher NAS and fibrosis stages.
This is an encore of an abstract that will be presented for the first time at the European Association for the Study of the Liver (EASL) Congress, 5–8 June 2024, Milan, Italy.

Disclosure

The ESSENCE trial is funded by Novo Nordisk A/S.
PNN: reports grants from Novo Nordisk, and has received consulting fees from Novo Nordisk, Boehringer Ingelheim, Gilead, Intercept, Poxel Pharmaceuticals, Bristol Myers Squibb (BMS), Pfizer, Sun Pharma, Madrigal and GSK. PNN also reports honoraria as a speaker for Novo Nordisk and AiCME; support for attending meetings for Novo Nordisk; and participation on an advisory board for Novo Nordisk, Boehringer Ingelheim, Gilead, Intercept, Poxel Pharmaceuticals, BMS, Pfizer, Sun Pharma, Madrigal and GSK.
EB: served as a consultant or advisory board member for Boehringer Ingelheim, Gilead, Intercept, Merck, Novo Nordisk, Pfizer, ProSciento, and as a speaker for Gilead, Intercept, Merck, Novo Nordisk and Pfizer. EB has also received a research grant from Gilead for fatty liver research.
VR: received consulting fees from Novo Nordisk, Sagimet, Madrigal, Enyo, Poxel, Northsea, Intercept and ProSciento, and research grants (to institution) from Gilead and Intercept.
MER: consults for Boehringer Ingelheim, CytoDyn, GSK, Novo Nordisk, HistoIndex, Intercept, Madrigal, NGM Bio and Sonic Incytes.
MR: reports grants from Boehringer Ingelheim and Novo Nordisk, and has received fees for consulting or participation in advisory boards for Boehringer Ingelheim, Echosens, Eli Lilly and Novo Nordisk. MR also reports honoraria as a speaker for AstraZeneca, Boehringer Ingelheim, Novo Nordisk and Madrigal.
AJS: consults for and advises Avant Santé and AstraZeneca. AJS also consults for and has received grants from Akero, BMS, Intercept, Eli Lilly, Madrigal and Novo Nordisk. AJS consults for and owns stock in Rivus, and also consults for AGED Diagnostics, Albireo, Alnylam, Altimmune, Boehringer Ingelheim, 89Bio, Echosens, Genentech, Gilead, GSK, HistoIndex, Mallinckrodt, Merck, NGM Bio, Novartis, PathAI, Pfizer, Poxel, Regeneron, Salix, Siemens, Surrozen, Takeda, Terns and Zydus. AJS owns stock in Durect, Exalenz, Genfit, Indalo, Inversago and Tiziana, and has received royalties from Elsevier and Wolters Kluwer.
KAE, IK, LHØ, DV and JZ: employees and stockholders of Novo Nordisk A/S.

PHASE 3 RANDOMISED, PLACEBO-CONTROLLED ESSENCE TRIAL OF SEMAGLUTIDE 2.4 MG IN PARTICIPANTS WITH NON-CIRRHOTIC NON-ALCOHOLIC STEATOHEPATITIS: BASELINE CHARACTERISTICS, IMPACT OF NEW METABOLIC DYSFUNCTION-ASSOCIATED STEATOTIC LIVER DISEASE CRITERIA AND NON-

Philip Newsome 1, Elisabetta Bugianesi 2, Vlad Ratziu 3, Mary Rinella 4, Michael Roden 5, Kristiane A. Engebretsen 6, Iris Kliers 6, Laura Harms Østergaard 6, Denise Vanni 6, Jeppe Zacho 6, Arun Sanyal 7

1 National Institute for Health Research, Birmingham Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University of Birmingham,

2 Department of Medical Sciences, University of Turin, Turin, Italy

3 Sorbonne Université, Institute for Cardiometabolism and Nutrition, Hospital Pitié-Salpêtrière, INSERM UMRS 1138 CRC, Paris, France

4 Department of Medicine, University of Chicago, Chicago, IL, United States

5 Department of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany|||German Center for Diabetes Research, Partner Düsseldorf, München-Neuherberg, Germany|||Institute f

6 Novo Nordisk A/S, Copenhagen, Denmark

7 Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, VCU School of Medicine, Richmond, VA, United States

Conference

UEG Week Vienna 2024

Topics

Hepatobiliary

Submission format

Abstract

Session

Epidemiology in MASLD (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Introduction

MAESTRO-NASH is an ongoing 54-month, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy of resmetirom in patients with biopsy-confirmed MASH and fibrosis. 966 patients with biopsy-confirmed NASH were randomized 1:1:1 to resmetirom 80 mg, resmetirom 100 mg, or placebo once daily. Dual primary endpoints at Week 52 were achieved with both resmetirom 80 mg and 100 mg: NASH resolution with no worsening of fibrosis (NR) or ≥1-stage improvement in fibrosis with no worsening of NAS (FI). Both Week 52 liver biopsy endpoints, NR and FI, were achieved. Resmetirom was recently approved for the treatment of adult patients with noncirrhotic NASH and liver fibrosis consistent with F2 to F3 stages. Expert guidance recommends treatment with resmetirom based on staging fibrosis using Vibration-Controlled Transient Elastography (VCTE). EASL recommends stratifying patients using Fibrosis-4 Index (FIB-4). Most guidelines recommend using VCTE cutoffs lower than 10 to <15 kPa for treatment.

Aims & Methods

We assessed results from baseline noninvasive tests (FIB-4, VCTE) against biopsy results in MAESTRO-NASH to measure how well they diagnosed noncirrhotic patients with NASH (consistent
with F2-F3 stages at baseline). We assessed the utility of a lower VCTE cutoff (8.5 to <10 kPa) in capture of F2 and F3 patients who otherwise would be missed. Also evaluated was the addition of
MRE/MRI-PDFF or ELF to VCTE to assess diagnostic utility.

Results

FIB-4 poorly predicted patients in the non-cirrhotic fibrosis stages: F2 (60% patients fell into low-risk) and F3 (40% fell into low-risk). Including a lower cutoff of VCTE (8.5 to <10 kPa) captured
F1B (34% 8.5 to <10 kPa) and many F2 (25% 8.5 to <10 kPa) and F3 patients (19% 8.5 to <10 kPa). The addition of MRE/MRI-PDFF to VCTE increased diagnostic accuracy for F2/F3 to 68% and
F4 to 81%. The addition of the ELF to the VCTE suggested that a low ELF result paired with high VCTE may warrant a VCTE repeat.

Conclusion

Identification of patients with NASH F2 to F3 was achieved with VCTE. F1B are F2 equivalent (F1B is moderate fibrosis on biopsy). Patients with fibrosis stage F4 were effectively ruled out. In addition to VCTE, practitioners may consider expanded noninvasive criteria (ELF, MRE) to help refine fibrosis staging.

Disclosure

This study was supported by Madrigal Pharmaceuticals, Inc.

USE OF NONINVASIVE TESTS (NITS) TO DIAGNOSE AND FOLLOW METABOLIC DYSFUNCTION ASSOCIATED STEATOHEPATITIS (MASH) WITH LIVER FIBROSIS PATIENTS TREATED WITH RESMETIROM

Jörn Schattenberg 1

1 Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Homburg, Germany

Conference

UEG Week Berlin 2025

Topics

Hepatobiliary

Submission format

Abstract

Session

MASH: Screening, monitoring and treatment (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

Metabolic dysfunction-associated steatohepatitis (MASH) is linked to increased risk of cardiovascular (CV) disease (CVD), but many aspects of CVD burden in patients with MASH remain unknown. Particularly, data on the clinical burden of CVD and specific CV events in patients with non-cirrhotic MASH vs those without non-cirrhotic MASH are limited.

Aims & Methods

The aim of this real-world study was to assess CVD burden in patients with and without non-cirrhotic MASH. Patients with MASH were identified using the International Classification of Diseases code for non-alcoholic steatohepatitis (K75.81) from October 2015–June 2022, using data from a federated network (TriNetX). The index date was defined as the date of first MASH diagnosis. Exclusion criteria were viral hepatitis, alcohol use disorder, chronic liver diseases other than MASH or metabolic dysfunction-associated steatotic liver disease, cirrhosis, decompensated MASH, hepatocellular carcinoma and human immunodeficiency virus. Patients with MASH were matched 1:1 to patients without MASH based on demographics (sex, age, year of start/end of insurance enrolment, and insurance scheme). Outcomes were CVD prevalence (assessed up to 1 year prior to index) and risk of CV events(s) during follow-up (index date to end of enrolment, death or study end) amongst patients with no history of respective CV event(s) at baseline. For CV risk, cumulative incidence was plotted using Aalen-Johansen curves after adjusting for competing risk of non-CV death. Incidence rate (IR) was calculated per 100 person-years (PY) and hazard ratios (HR) were calculated using Cox proportional hazard models (crude and adjusted for CV risk factors [age, sex, type 2 diabetes (T2D), chronic kidney disease (CKD), obesity, hyperlipidaemia and hypertension]).

Results

In total, 9,642 patients (4,821 with MASH; 4,821 without MASH) were included. In both groups, mean (standard deviation) age was 50.8 (13.2) years and 58.5% were women. Compared with those without MASH, more patients with MASH had hypertension (58% vs 31%), hyperlipidaemia (57% vs 30%), obesity (45% vs 17%), T2D (41% vs 14%) and CKD (6% vs 3%) at baseline. Prevalence of any CVD was higher in patients with MASH than without MASH (23% vs 12%), as was risk of any CV event (IR: 11.1 vs 4.5 per 100 PY; crude HR [95% confidence interval]: 2.72 [2.30, 3.22], p < 0.0001; adjusted HR: 2.27 [1.95, 2.66], p < 0.0001). Similar results were seen for individual CV events, namely ischaemic heart disease (IR: 5.3 vs 2.3), cerebrovascular disease (IR: 4.4 vs 2.1), atherosclerosis (IR: 3.9 vs 1.8), and heart failure (IR: 3.2 vs 1.5).

Conclusion

CVD prevalence at baseline and risk of CV events during follow-up were significantly higher in patients with non-cirrhotic MASH compared with matched controls without MASH in a real-world cohort. These data provide additional evidence of the association between MASH and CVD and complement a previous analysis of the unCoVer-MASH study.

Disclosure

EB has acted as a consultant for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences, Intercept Pharmaceuticals, Inventiva SA, Merck Sharp & Dohme (UK) limited, Novo Nordisk and Pfizer.
AM has no conflicts of interest.
KKM, ASC, KG, NK and ASP are employees of Novo Nordisk A/S and own employee shares/stocks.
KEC has acted as a consultant for Theratechnologies and Novo Nordisk, and has received grants from Bristol Myers Squibb and Novartis.

CARDIOVASCULAR DISEASE BURDEN IN PATIENTS WITH METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS VERSUS MATCHED-CONTROL PATIENTS: DATA FROM THE UNCOVER-MASH LONGITUDINAL COHORT STUDY

Elisabetta Bugianesi 1, Anurag Mehta 2, Kamal Kant Mangla 3, Abhishek Shankar Chandramouli 4, Katrine Grau 3, Niels Krarup 3, Ahsan Shoeb 3, Kwabena Opuni 3

1 Department of Medical Sciences, University of Turin, Turin, Italy

2 VCU Health Pauley Heart Center, Richmond, VA, United States

3 Novo Nordisk A/S, Søborg, Denmark

4 Novo Nordisk Service Center India Pvt Ltd, Bangalore, India

Conference

UEG Week Vienna 2024

Topics

Hepatobiliary

Submission format

Abstract

Session

LIVER (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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