A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH (ZENITH-1)

April 13, 2026 updated by: GlaxoSmithKline

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)

The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Arcadia, California, United States, 91006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elias Tarakji
      • Covina, California, United States, 91723
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masoud Azizad
      • Los Angeles, California, United States, 90057
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Lamb
      • Santa Maria, California, United States, 93458
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Keval Shah
      • Van Nuys, California, United States, 91405
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Jenders
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aaron Cohen
      • Cape Coral, Florida, United States, 33914
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paige Kreegel
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Diaz
      • Inverness, Florida, United States, 34452
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul Hellstern Jr.
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffry Jacqmein
      • Kissimmee, Florida, United States, 34744
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Alvarado
      • Lakeland, Florida, United States, 33803
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • James Andersen
      • Maitland, Florida, United States, 32751
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Eva Maria Heurich
        • Contact:
      • Miami, Florida, United States, 33144
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos Ramos
      • Miami, Florida, United States, 33155
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • JORGE AMAYA
        • Contact:
        • Contact:
      • Miami, Florida, United States, 33156
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lazaro M Garcia
      • Miami, Florida, United States, 33135
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yaneicy Gonzalez Rojas
      • Miami, Florida, United States, 33184
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Franciso Bautista
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Aponte
      • Ocala, Florida, United States, 34471
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Robert Barish
        • Contact:
        • Contact:
      • Palmetto Bay, Florida, United States, 33157
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karen Figueredo Reyes
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shekhar Challa
        • Contact:
        • Contact:
    • Missouri
      • Springfield, Missouri, United States, 62703
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dmitry Shuster
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fred Williams
    • New York
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Barbara Connor
      • New York, New York, United States, 10036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eli Shalenberg
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kathryn Lucas
        • Contact:
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44320
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ganesh Veerappan
      • Springboro, Ohio, United States, 45066
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anjali Morey
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chirag Patel
        • Contact:
        • Contact:
    • Texas
      • Austin, Texas, United States, 78704
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nomita Kim
      • Austin, Texas, United States, 78759
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Patrick Zimmerman
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Everald Manning
      • Brownsville, Texas, United States, 78526
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Christopher Romero
        • Contact:
        • Contact:
      • Dallas, Texas, United States, 75243
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valentine Ebuh
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • HARESH BOGHARA
      • Richmond, Texas, United States, 77406
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brian Chou
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emanuel DeNoia
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Eric Lawitz
        • Contact:
        • Contact:
      • Seabrook, Texas, United States, 77586
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joe Pouzar
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Harish Thakkar
        • Contact:
        • Contact:
      • Tomball, Texas, United States, 77375
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhammad Irfan
      • Waco, Texas, United States, 76712
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hanumantha Ancha
      • Waco, Texas, United States, 76710
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gregg Lucksinger
        • Contact:
        • Contact:
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Barbara Rizzardi
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nabil Andrawis
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kris Kowdley
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
  2. Age >=18 and <=75 years at enrollment
  3. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
  4. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score >=4 confirmed by a central pathologist

Exclusion Criteria:

  1. Contraindication or ineligibility for percutaneous liver biopsy
  2. ALT or AST >=5 x upper limit of normal (ULN)
  3. Total bilirubin >=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of >=1.3 mg/dL and direct bilirubin is <=20% of total bilirubin; otherwise, the individual will be excluded.
  4. Serum albumin <=3.5 grams per deciliter (g/dL)
  5. International normalized ratio (INR) >=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
  6. Alkaline phosphatase (ALP) >=2*ULN
  7. Platelet (PLT) count <140,000 per (/) cubic millimeter (mm^3); individuals with a PLT count between 110,000/mm^3 and 140,000/mm^3 may be enrolled after discussion with the Study Medical Monitor.
  8. Serum creatinine >=1.5 mg/dL or creatinine clearance <=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation
  9. Alpha-fetoprotein >=20 nanogram per milliliter (ng/mL)
  10. Glycated hemoglobin >=9.0%
  11. Model for End-Stage Liver Disease score >=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)
  12. Phosphatidyl ethanol (PEth) >=80 ng/mL at Screening

  13. Evidence of infection with any of the following:

    1. Human immunodeficiency virus;
    2. Hepatitis B virus (detectable HBsAg at Screening);
    3. Hepatitis C virus (HCV);
  14. Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis or any history or evidence of cirrhosis on screening liver biopsy; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
  15. Current or history of excessive alcohol intake for >=3 months within the 12-month period prior to Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Participants receiving Placebo
Drug: Placebo
Placebo will be administered
Experimental: Participants receiving dose level 1 of efimosfermin alfa
Drug: Efimosfermin alfa
Efimosfermin alfa will be administered
Experimental: Participants receiving dose level 2 of efimosfermin alfa
Drug: Efimosfermin alfa
Efimosfermin alfa will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants experiencing improvement in fibrosis by >=1 stage and no worsening of steatohepatitis at Week 52
Time Frame: At Week 52
Proportion of participants experiencing improvement in fibrosis of greater than or equal to (>=) 1 stage by MASH clinical research network (CRN) fibrosis scores and no worsening of steatohepatitis (defined as no increase in nonalcoholic fatty liver disease activity score [NAS] for ballooning, inflammation, or steatosis) at 52 weeks will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. NAS score ranges from 0 to 8, higher score indicates worse disease activity.
At Week 52
Proportion of participants experiencing resolution of steatohepatitis reading and no worsening of MASH CRN fibrosis score at Week 52
Time Frame: At Week 52
Resolution of steatohepatitis is defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0 or 1 for inflammation, 0 for ballooning, and any value for steatosis. NAS score ranges from 0 to 8, higher score indicates worse disease activity. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.
At Week 52
Time from randomization to an adjudicated composite liver-related clinical outcome
Time Frame: From Randomization (Day 1) to 48 months
Liver-related outcome will comprised of all-cause mortality; transplantation; occurrence of significant hepatic events.
From Randomization (Day 1) to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Time Frame: At Week 52 and at Month 48
At Week 52 and at Month 48
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Time Frame: At Week 52 and at Month 48
At Week 52 and at Month 48
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
Time Frame: At Week 52 and at Month 48
At Week 52 and at Month 48
Proportion of participants experiencing resolution of steatohepatitis on overall histopathological reading and improvement in liver fibrosis of >=1 stage at Week 52
Time Frame: At Week 52
Resolution of steatohepatitis is defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis on overall histopathological reading on liver biopsies. Proportion of participants experiencing improvement in fibrosis of >=1 stage by MASH CRN fibrosis scores and resolution of steatohepatitis on overall histopathological reading at 52 weeks will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity
At Week 52
Proportion of participants experiencing improvement in fibrosis by >=1 stage and no worsening of Steatohepatitis at Month 48
Time Frame: At Month 48
Proportion of participants experiencing improvement in fibrosis of >=1 stage by MASH CRN fibrosis scores and no worsening of steatohepatitis (defined as no increase in NAS for ballooning, inflammation, or steatosis) at Month 48 will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. NAS score ranges from 0 to 8, higher score indicates worse disease activity.
At Month 48
Proportion of participants experiencing improvement in fibrosis by >=2 stage and no worsening of Steatohepatitis at Week 52 and Month 48
Time Frame: At Week 52 and Month 48
Proportion of participants experiencing improvement in fibrosis of >=2 stage by MASH CRN fibrosis scores and no worsening of steatohepatitis (defined as no increase in NAS for ballooning, inflammation, or steatosis) at at Week 52 and Month 48 will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. NAS score ranges from 0 to 8, higher score indicates worse disease activity
At Week 52 and Month 48
Proportion of participants experiencing resolution of steatohepatitis reading and no worsening of MASH CRN score at Month 48
Time Frame: At Month 48
Resolution of steatohepatitis is defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0 or 1 for inflammation, 0 for ballooning, and any value for steatosis. NAS score ranges from 0 to 8, higher score indicates worse disease activity. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.
At Month 48
Absolute change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)
Time Frame: Baseline (Day 1), Week 52 and Month 48
Baseline (Day 1), Week 52 and Month 48
Absolute change from Baseline in controlled attenuation parameter (CAP) scores
Time Frame: Baseline (Day 1), Week 52 and Month 48
The CAP score is measured by FibroScan, will be used to quantify and detect liver fat. CAP less than (<) 238 decibel-milliwatts (dB/m) indicated no hepatic steatosis, 238 less than or equal to (<=) CAP <=259 dB/m denoted mild steatosis, 260 <=CAP <=291 dB/m indicated moderate steatosis, and CAP greater than (>) 291 dB/m denoted severe steatosis.
Baseline (Day 1), Week 52 and Month 48
Proportion of participants achieving Change from Baseline in VCTE-LSM >=30 percent (%) at Week 52 and Month 48
Time Frame: Baseline (Day 1), Week 52 and Month 48
VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascal (kPa).
Baseline (Day 1), Week 52 and Month 48
Absolute change from Baseline in magnetic resonance elastography (MRE) scores
Time Frame: Baseline (Day 1), Week 52 and Month 48
MRE is a non-invasive imaging technique that combine magnetic resonance imaging (MRI) scanning with low-frequency mechanical vibrations to measure the stiffness of liver. MRE scores <2.5 is normal, 2.5 - 3.0 Normal or inflammation, 3.0 - 3.5 Stage 1-2 fibrosis, 3.5 - 4.0 Stage 2-3 fibrosis, 4.0 - 5.0 Stage 3-4 fibrosis and > 5.0 Stage 4 fibrosis.
Baseline (Day 1), Week 52 and Month 48
Absolute change from Baseline in Enhanced Liver Fibrosis (ELF) Score
Time Frame: Baseline (Day 1), Week 52 and Month 48
The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score <9.8: Low risk of progression, ELF score 9.8 to <11.3: Moderate risk of progression and ELF score >=11.3: High risk of progression.
Baseline (Day 1), Week 52 and Month 48
Proportion of participants experiencing improvement in ELF score of >=0.5
Time Frame: At Week 52 and Month 48
The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score <9.8: Low risk of progression, ELF score 9.8 to <11.3: Moderate risk of progression and ELF score >=11.3: High risk of progression.
At Week 52 and Month 48
Absolute change from Baseline in hepatic fat fraction (HFF) by MRI-derived proton density fat fraction (PDFF)
Time Frame: Baseline (Day 1), Week 52 and Month 48
HFF is the percentage of fat in the liver measured by MRI proton density fat fraction technique, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver.
Baseline (Day 1), Week 52 and Month 48
Absolute change from Baseline in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (International units per liter)
Time Frame: Baseline (Day 1), Week 52 and Month 48
Baseline (Day 1), Week 52 and Month 48
Absolute change from Baseline in ALT and AST ratio (ALT/AST)
Time Frame: Baseline (Day 1), Week 52 and Month 48
ALT/AST ratio is calculated as ALT/AST ratio equal to ALT divided by AST.
Baseline (Day 1), Week 52 and Month 48
Proportion of participants experiencing ALT and HFF normalization at Week 52 and Month 48
Time Frame: At Week 52 and Month 48
At Week 52 and Month 48
Proportion of participants experiencing HFF <=5% at Week 52 and Month 48
Time Frame: At Week 52 and Month 48
HFF is the percentage of fat in the liver measured by MRI proton density fat fraction technique, which ranges from 0-75%. Less than or equal to 5% is considered normal (no significant fatty infiltration (steatosis) in the liver.
At Week 52 and Month 48
Change from Baseline in glycated hemoglobin (HbA1c) (Percentage of HbA1c) in participants with Type 2 Diabetes Mellitus (T2DM)
Time Frame: Baseline (Day 1), Week 52 and Month 48
Baseline (Day 1), Week 52 and Month 48
Change from Baseline in body weight (kilograms)
Time Frame: Baseline (Day 1), Week 52 and Month 48
Baseline (Day 1), Week 52 and Month 48
Change from Baseline in fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)- cholesterol, and triglycerides (Millimoles per liter)
Time Frame: Baseline (Day 1), Week 52 and Month 48
Baseline (Day 1), Week 52 and Month 48
Proportion of participants with antidrug and antiFGF21 antibody (ADA)
Time Frame: At Week 52 and Month 48
At Week 52 and Month 48
Change from Baseline in Chronic Liver Disease Questionnaire-Nonalcoholic Steatohepatitis (CLDQ-NASH) in domain and total score
Time Frame: Baseline (Day 1), Week 52 and Month 48
CLDQ-NASH is a NASH-specific health-related quality of life (HRQoL) Patient-Reported Outcomes (PRO) designed to assess 6 health domains over 36 items: abdominal symptoms (3 items), activity/energy (5 items), emotional health (9 items), fatigue (6 items), systemic symptoms (6 items) and worry (7 items). The domain scores range from 1 to 7, higher scores indicating better HRQoL. A score of 1 meaning the symptom being assessed is "present always" while a score of 7 means the symptom is "never present". The total score can range from 36 to 252, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life.
Baseline (Day 1), Week 52 and Month 48
Change from Baseline in Short Form-36 (SF-36) component and domain scores at Week 52 and Month 48
Time Frame: Baseline (Day 1), Week 52 and Month 48
SF-36 is a generic HRQoL PRO designed to assess 8 health domains over 36 items: physical functioning (10 items), bodily pain (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), general health (5 items), mental health (5 items), social functioning (2 items), and vitality (4 items). Each domain is scored from 0 (poorer health) to 100 (better health). SF-36 is scored into 8 domains and 2 component scores: physical component summary (PCS) and mental component summary (MCS). The domain and component scores range from 0 to 100, with higher scores indicating better HRQoL.
Baseline (Day 1), Week 52 and Month 48
Serum drug Concentration of efimosfermin alfa
Time Frame: Up to Month 48
Up to Month 48
Percent change from Baseline in VCTE-LSM
Time Frame: Baseline (Day 1), Week 52 and Month 48
Baseline (Day 1), Week 52 and Month 48
Percent change from Baseline in CAP scores
Time Frame: Baseline (Day 1), Week 52 and Month 48
The CAP score is measured by FibroScan, will be used to quantify and detect liver fat. CAP <238 dB/m indicated no hepatic steatosis, 238 <=CAP <=259 dB/m denoted mild steatosis, 260 <=CAP <=291 dB/m indicated moderate steatosis, and CAP >291 dB/m denoted severe steatosis.
Baseline (Day 1), Week 52 and Month 48
Percent change from Baseline in MRE Score
Time Frame: Baseline (Day 1), Week 52 and Month 48
MRE is a non-invasive imaging technique that combine MRI scanning with low-frequency mechanical vibrations to measure the stiffness of liver. MRE scores <2.5 is normal, 2.5 - 3.0 Normal or inflammation, 3.0 - 3.5 Stage 1-2 fibrosis, 3.5 - 4.0 Stage 2-3 fibrosis, 4.0 - 5.0 Stage 3-4 fibrosis and > 5.0 Stage 4 fibrosis.
Baseline (Day 1), Week 52 and Month 48
Percent change from Baseline in ELF Score
Time Frame: Baseline (Day 1), Week 52 and Month 48
The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers. The ELF score is used as a prognostic marker for disease progression: ELF score <9.8: Low risk of progression, ELF score 9.8 to <11.3: Moderate risk of progression and ELF score >=11.3: High risk of progression.
Baseline (Day 1), Week 52 and Month 48
Percent change from Baseline in HFF by MRI-PDFF
Time Frame: Baseline (Day 1), Week 52 and Month 48
HFF is the percentage of fat in the liver measured by MRI proton density fat fraction technique, which ranges from 0-75%. Greater than 5% is considered extra fat in the liver.
Baseline (Day 1), Week 52 and Month 48
Percent change from Baseline in ALT and AST (International units per liter)
Time Frame: Baseline (Day 1), Week 52 and Month 48
Baseline (Day 1), Week 52 and Month 48
Percent change from Baseline in ALT and AST ratio (ALT/AST)
Time Frame: Baseline (Day 1), Week 52 and Month 48
ALT/AST ratio is calculated as ALT/AST ratio equal to ALT divided by AST.
Baseline (Day 1), Week 52 and Month 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2025

Primary Completion (Estimated)

March 29, 2028

Study Completion (Estimated)

December 12, 2031

Study Registration Dates

First Submitted

October 15, 2025

First Submitted That Met QC Criteria

October 24, 2025

First Posted (Actual)

October 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301160
  • 2025-523675-39 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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