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GSK4532990 for NASH (HORIZON Trial)
Verified Trial
Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and at week 24 and 52
Summary
This trial is testing a new drug called GSK4532990 to see if it can help people with severe liver damage caused by NASH. The drug aims to reduce liver scarring and swelling. The study will last over a year, with about a year of treatment.
Who is the study for?
Adults with a liver condition called NASH and advanced fibrosis can join this trial. They must have a BMI of at least 25, or 23 for Asian participants, and show certain features on a liver biopsy. Participants need to be able to follow the study plan, including another biopsy after one year. People who've had weight reduction surgery recently, have cirrhosis, drink heavily, or had cancer (except some skin cancers) in the last two years cannot join.
What is being tested?
The trial is testing GSK4532990 against a placebo to see if it's better at reducing liver scarring and inflammation in people with NASH. Everyone will be randomly assigned to either get GSK4532990 or a dummy pill (placebo), and they won't know which one they're taking for up to 52 weeks of treatment.
What are the potential side effects?
Possible side effects of GSK4532990 are not detailed here but could include reactions similar to other medications that target liver conditions such as digestive issues, discomfort at the injection site if applicable, fatigue, and potential changes in blood tests related to liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and at week 24 and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and at week 24 and 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - F3 Cohort
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - F3 Cohort
Secondary study objectives
Change from baseline in Enhanced Liver Fibrosis (ELF) Score - F3 Cohort
Change from baseline in Enhanced Liver Fibrosis (ELF) Score - Pooled Cohort (F3 participants and F4 participants)
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - Pooled Cohort (F3 participants and F4 participants)
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose GSK4532990Experimental Treatment1 Intervention
Group II: High Dose GSK4532990Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,812 Previous Clinical Trials
8,381,926 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
499 Patients Enrolled for Non-alcoholic Fatty Liver Disease
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,605 Previous Clinical Trials
6,144,749 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
292 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor thinks my liver issues are mostly due to fatty liver disease linked to metabolic syndrome.My liver biopsy shows I have significant fatty liver disease with inflammation and scarring.I have been diagnosed with cirrhosis through a biopsy.I have not had weight loss surgery in the last 2 years.I haven't had any cancer except for non-melanoma skin cancer, which was completely removed, in the last 2 years.My doctor thinks my liver issues are due to NAFLD, possibly because I have diabetes, obesity, high cholesterol, or high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose GSK4532990
- Group 2: Low Dose GSK4532990
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05583344 — Phase 2