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PEGOZAFERMIN DEMONSTRATED ROBUST HISTOLOGICAL IMPROVEMENT AND BENEFIT IN HEPATIC AND METABOLIC BIOMARKERS: RESULTS FROM A 48-WEEK MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL (ENLIVEN)

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PEGOZAFERMIN DEMONSTRATED ROBUST HISTOLOGICAL IMPROVEMENT AND BENEFIT IN HEPATIC AND METABOLIC BIOMARKERS: RESULTS FROM A 48-WEEK MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL (ENLIVEN)

Jörn Schattenberg 1, Arun Sanyal 2, Naim Alkhouri 3, Mildred D. Gottwald 4, Shibao Feng 4, Germaine D. Agollah 4, Cynthia L Hartsfield 4, Hank Mansbach 4, Maya Margalit 5, Rohit Loomba 6

Affiliations

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

2 Virginia Commonwealth University School of Medicine, Richmond, United States

3 Arizona Liver Health, Phoenix, United States

4 89bio, San Francisco, United States

5 89bio, Rehovot, Israel

6 University of California San Diego MASLD Research Center, San Diego, United States

Summary

AI Generated

Pegozafermin, an FGF21 analog, demonstrated statistically significant fibrosis regression and MASH resolution at 24 weeks in patients with F2/F3 fibrosis in the Phase 2b ENLIVEN trial.

Treatment with pegozafermin 30mg weekly or 44mg every two weeks achieved both primary histological endpoints: one-stage fibrosis improvement without worsening of MASH and MASH resolution without worsening of fibrosis, compared to placebo.
Pegozafermin is the first therapy to achieve fibrosis regression and MASH resolution with an every-two-week dosing regimen.
Non-invasive tests at weeks 24 and 48 showed robust and sustained reductions in liver fat content by MRI-PDFF, biomarkers of fibrosis including VCTE, ELF, and PRO-C3, and liver injury markers ALT and AST.
Metabolic parameters including lipids and HbA1c improved at both 24 and 48 weeks.
Pegozafermin was generally safe and well tolerated, with the most common adverse events being mild to moderate nausea and diarrhea; no deaths occurred and six patients discontinued early for treatment-emergent adverse events including one drug-related serious adverse event.
Phase 3 studies ENLIGHTEN-Fibrosis in noncirrhotic patients and ENLIGHTEN-cirrhosis in cirrhotic patients are currently underway.

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Abstract

Introduction

Metabolic dysfunction-associated steatohepatitis (MASH) is often associated with metabolic disorders such as obesity, metabolic syndrome, and/or diabetes. FGF21 analogs are promising therapies for MASH due to their direct anti-fibrotic effects as well as additional hepatic and extrahepatic benefits. Pegozafermin (PGZ), an FGF21 analog, was evaluated for safety and efficacy in a Phase 2b trial (ENLIVEN) with either weekly (QW) or every two-week (Q2W) dosing versus matching placebo in MASH patients with biopsy-proven F2/F3 fibrosis. Primary histology endpoints and non-invasive tests (NITs) were assessed at week 24, followed by additional NIT evaluation at the end of a 24-week blinded extension for a total of 48 weeks.

Aims & Methods

Patients were randomized to PGZ 15mg QW, 30mg QW, or 44mg Q2W or placebo for 24 weeks (histology-based primary endpoints). During the 24-week extension, most patients continued their assigned treatment with the exception of a subset of placebo patients who were re-randomized to receive PGZ 30mg QW. The full analysis set includes F2/F3 patients with NAFLD activity score (NAS) ≥4 at baseline (n=192).

Results

At 24-weeks, PGZ 30mg QW or 44mg Q2W led to statistically significant and clinical meaningful improvement in both primary histological endpoints (one stage of fibrosis improvement without worsening of MASH and MASH resolution without worsening of fibrosis) compared to placebo. Non-invasive testing at weeks 24 and 48 demonstrated that PGZ treatment was associated with robust and sustained reductions in liver fat content (MRI-PDFF), biomarkers of fibrosis (VCTE, ELF, PRO-C3) and liver injury (ALT, AST). PGZ also improved metabolic parameters such as lipids and HbA1c at both 24 and 48 weeks. PGZ was generally safe and well tolerated with the most common treatment emergent adverse events (TEAEs) being mild/moderate nausea and diarrhea. No deaths occurred; six early terminations for TEAEs including one drug-related serious AE occurred.

Conclusion

At 24 weeks, treatment with PGZ in MASH patients with F2/F3 fibrosis led to significant fibrosis regression and MASH resolution, which was corroborated by improvement across a variety of non-invasive tests including liver fat, inflammation, fibrosis, and metabolic markers. Benefits on NITs were sustained over the full 48-weeks of the study, with favorable safety and tolerability. PGZ is the first therapy to achieve fibrosis regression and MASH resolution with a Q2W dosing regimen. Phase 3 studies in noncirrhotic (ENLIGHTEN-Fibrosis) and cirrhotic (ENLIGHTEN-cirrhosis) patients are currently underway to confirm these results.

Disclosure

Jörn Schattenberg: Consultant: Akero, Alentis Therapeutics, Astra Zeneca, 89Bio, Boehringer Ingelheim, GSK, Ipsen, Inventiva Pharma, Madrigal, MSD, Northsea Therapeutics, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Siemens Healthineers; Speaker: Gilead Sciences, Advanz, Echosens, MedPublico GmbH; Grants: Boehringer Ingelheim, Siemens Healthcare GmbH; Stock Options: AGED diagnostics, Hepta Bio
Arun J Sanyal: Consulting: Genefit, Gilead, Malinckrodt, Pfizer, Salix, Boehringer Ingelheim, Novartis, Bristol Meyers Squibb, Merck, Hemoshear, Lilly, Novo Nordisk, Terns, Albireo, Jannsen, Poxel, 89bio, Siemens, AstraZeneca, NGM Bio, Amgen, Regeneron, Genentech, Alnylam, Roche, Madrigal, Inventiva, Covance, Prosciento, HistoIndex, PathAI; Grants: Gilead, Malinckrodt, Boehringer Ingelheim, Novartis, Bristol Meyers Squibb, Merck, Lilly, Novo Nordisk, Fractyl, Madrigal, Inventiva; Stock holder: Exhalenz, GenFit, Hemoshear, Durect, Indalo, NorthSea, Tiziana, Rivus
Naim Alkhouri: Research funding: 89Bio, AbbVie/Allergan, Akero, Better Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Corcept, DSM, Galectin, Genentech, Genfit, Gilead, Hepagene, Healio, Intercept, Inventiva, Ionis, Madrigal, Merck, NGM, Noom, NorthSea, Novo Nordisk, Perspectum, Pfizer, Poxel, Viking, and Zydus; Speaker bureau: AbbVie/Allergan, Alexion, Echosens, Eisai, Exelixis, Gilead, Intercept, Perspectum, Salix, and Theratechnologies; Consultant: 89Bio, AbbVie/Allergan, Echosens, Fibronostics, Gilead, Intercept, Madrigal, Novo Nordisk, Perspectum, Pfizer, and Zydus.
Rohit Loomba: Consultant: Aardvark Therapeutics, Altimmune, Anylam/Regeneron, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Boston Pharmaceuticals, Bristol-Meyers Squibb, CohBar, Eli Lilly, Galmed, Gilead, Glympse Bio, Hightide, Inipharma, Intercept, Inventiva, Ionis, Janssen Inc., Madrigal, Metacrine, Inc., NGM Biopharmaceuticals, Novartis, Novo Nordisk, Merck, Pfizer, Sagimet, Theratechnologies, 89bio, Terns Pharmaceuticals and Viking Therapeutics; Grants: Arrowhead Pharmacetuicals, AstraZeneca, Boegringer-Ingelheim, Bristol-Meyers Squibb, Eli Lilly, Galectin Therapeutics, Galmeed Pharmaceuticals, Gilead, Hanmi, Intercept, Inventiva, Ionis, Janssen, Madrigal Pharmaceuticals, Merck, NGM Biopharmaceuticals, Novo Nordisk, Pfizer, Sonic Incytes and Terns Pharmaceuticals; Stockholder: Co-founder LipoNexus, Inc
Mildred D Gottwald, Shibao Feng, Germaine D Agollah, Cynthia L Hartsfield, Hank Mansbach, Maya Margalit: 89bio employee and stock holder

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

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1 Al Jalila Children's Specialty Hospital, DUBAI, United Arab Emirates

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UEG Week Berlin 2025

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Endoscopy Nurses Paediatrics Surgery

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Crash course: Foreign bodies

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

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Affiliations

1 Division of Gastroenterology, Hospital Beatriz Ângelo, Loures, Portugal

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Event

UEG Week Berlin 2025

Topics

IBD Mechanisms & Personalised Medicine Paediatrics Surgery

Session

What's new in ulcerative colitis 2025?

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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BURNOUT SYNDROME ASSESSMENT OF NURSING STAFF IN A DIGESTIVE ENDOSCOPY UNIT AT A TERTIARY REFERRAL HOSPITAL

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BURNOUT SYNDROME ASSESSMENT OF NURSING STAFF IN A DIGESTIVE ENDOSCOPY UNIT AT A TERTIARY REFERRAL HOSPITAL

YAIZA DEL CARMEN TORRES ZAMORA 1

Affiliations

1 Complejo Hospitalario Insular Materno Infantil, Las Palmas de Gran Canaria, Spain

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Abstract

Introduction

Burnout Syndrome is a subject that has been studied for several decades. Despite the fact that is a well-known topic and that more and more people are suffering from it, the bibliography shows that there are no great changes in it and as a consequence, there are still great deficiencies in the prevention of this syndrome today.
In 1981, Maslach and Jackson defined Burnout as a syndrome that occurs when there is inadequate coping with chronic stress, i.e., as a consequence of continuous work stress, negative attitudes and feelings appear both in the professional role itself and towards colleagues, and this makes the person suffering from it emotionally exhausted.
Burnout syndrome is now considered a public health problem because of the number and severity of the consequences for the physical and psychological integrity of workers. According to the International Council of Nurses, professionals who suffer higher levels of work and personal stress are 30% more likely to suffer accidents in their workplace. This means that on the one hand the person suffering from work-related stress and/or burnout syndrome has a series of complications of varying degrees of severity and on the other hand the organisation has to bear the costs involved (e.g. sick leave).

Results & Findings

Observational, descriptive and cross-sectional study, carried out in March 2025 on the nursing staff of our Digestive Endoscopy Unit. A survey was distributed with a section for the analysis of socio-demographic data and another presenting the Maslach Burnout Inventory (MBI) questionnaire.
Descriptive statistical analysis was performed using frequency and association tables.
All questionnaires received were analysed and no exclusion criteria were established. Total sample was 30 professionals, 18 nurses (60%) and 12 TCAES (40%).

Interpreting MBI Scores	LOW BURNOUT	MODERATE BURNOUT	HIGH BURNOUT
EMOTIONAL EXHAUSTION	<19	19-26	>27
DEPERSONALIZATION	<5	6-9	>10
PERSONAL ACCOMPLISHMENT	<33	34-39	>40

Burnout Syndrome was evident in 4 professionals (13,3%) and a total of 10 professionals (33,3%) showed a tendency to suffer from it.

Summary & Discussion

Proffesionals with presence and/or tendency to suffer burnout is characterised by being a professional of nursing on a temporary contract, female, aged 31-45 years and who have been working in our Endoscopy Unit from 5 to 10 years.
It is worth emphasising that there is a significant percentage of professionals who suffer from a high level of emotional exhaustion (63,3%)
Excessive workload (73,3%) and high-pressure job (52,6%), as well as poor workplace relationships (73,7%) are the main precursors highlighted by professionals for the appearance of burn out.

Conclusion

These data show that this is a latent problem and it is therefore necessary to take measures, both of an organisational nature and to intervene in the
nursing staff.

References

Maslach C, Schaufeli WB, Leiter M. 2001. Job burnout. Annual Review of Psychology. 52, 397-422.Gordon, S. 2005.
ICN (13 January 2021). Mass Trauma Experienced by the Global Nursing Workforce. [Internet] 2021 [Access 30/03/2025] Available at: https://www.icn.ch/sites/default/files/inline-files/ICN%20COVID19%20update%20report%20FINAL.pdf
Nursing against the odds: How health care cost cutting, media stereotypes, and medical hubris undermine nurses and patient care. Ithaca, NY: ILR Press (Cornell University Press).
Baiget, D, Chapela, R, López-Pérez, A, Milà, A. Síndrome de burnout entre el personal de enfermería del Servicio de Endoscopia Digestiva del HUVH. Enferm Endosc Dig. [Internet] 2016 [Access 30/03/2025];3(2): 30-37. Available at: http://aeeed.com/documentos/publicos/revista/octubre2016/Enferm%20Endosc %20Dig.%202016;3(2)30-37.pdf

Event

UEG Week Berlin 2025

Topics

Nurses

Submission format

Abstract

Session

Abstracts I: Management and education

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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1 IPO Porto, Porto, Portugal

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UEG Week Berlin 2025

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Digestive Oncology Endoscopy Mechanisms & Personalised Medicine Stomach & H. Pylori Surgery

Session

Gastric cancer: MDT approach

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1 Univertsity of Oslo, Oslo, Norway

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Event

UEG Week Berlin 2025

Topics

Colorectal Hepatobiliary Primary Care

Session

Cross-cutting: Management changes in high prevalence problems

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

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Philip Newsome 1

Affiliations

1 University of Birmingham, Birmingham, United Kingdom

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Abstract

Event

UEG Week Berlin 2025

Topics

Hepatobiliary Nurses Small Intestine & Nutrition Pancreas

Session

Mistakes in …: Hepatobiliary and pancreas

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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