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Phase 2b Study of GSK4532990 in Adults With NASH | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Phase 2b Study of GSK4532990 in Adults With NASH

17 β-Hydroxysteroid Dehydrogenase Type 13 Minimization for the Treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults With Nonalcoholic Steatohepatitis

NCT05583344•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Body Mass Index (BMI) ≥25 kilogram per meter square (kg/m\^2) (all ethnic origins) except for Asian participants who qualify for the study with BMI ≥23 kg/m2 at Screening.
•In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension.
•A liver biopsy at baseline showing NAFLD Activity Score (NAS) \>=4 with at least 1 point each in steatosis, inflammation and ballooning and either Fibrosis 3 or Fibrosis 4 using NASH CRN Scoring System.
•Able and willing to comply with all study assessments, including a liver biopsy at Week 52.

Exclusion Criteria

•Current alcohol consumption ≥14 standard drinks (24 units, 196 g ethanol) per week for females or ≥21 standard drinks (37 units, 294g ethanol) per week for males.
•Weight reduction surgery or procedures (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1 and/or planned during the study.
•History of cancer within previous 2 years from Screening 1, except basal or squamous cell carcinoma of the skin or in situ cervical carcinoma or any other type of cancer which has been treated medically or surgically with curative outcome.

Locations (170)

GSK Investigational Site

Homewood, Alabama, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

North Little Rock, Arkansas, United States

GSK Investigational Site

Huntington Park, California, United States

GSK Investigational Site

La Jolla, California, United States

GSK Investigational Site

Orange, California, United States

GSK Investigational Site

Poway, California, United States

Key Dates

Start Date

January 2, 2023

Primary Completion Date

February 10, 2026

Completion Date

April 5, 2027

Last Updated

October 27, 2025

Enrollment

284

ACTUAL participants

Conditions

Nonalcoholic Fatty Liver DiseaseNon-alcoholic Fatty Liver Disease

Interventions

GSK4532990

DRUG

Placebo

DRUG

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

NCT07237750

Overweight and/or ObesityMetabolic Syndrome+2 more

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RECRUITING

Identification of Liver Fibrosis Biomarkers

NCT06819917

Non-alcoholic Fatty LiverNon-Alcoholic Fatty Liver Disease+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 2b Study of GSK4532990 in Adults With NASH

Inclusion Criteria

Exclusion Criteria

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

Identification of Liver Fibrosis Biomarkers

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

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

Nonalcoholic Steatohepatitis in Chinese Children