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GSK4532990 for NASH (HORIZON Trial)

Verified Trial
Phase 2
Recruiting
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 pre-dose (day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

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 weeks
Treatment ~ Varies
Follow Up ~pre-dose (day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose (day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose for reporting.

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
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 - F3 Cohort
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 - F4 Cohort
Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - F3 Cohort
+37 more

Trial 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
4,805 Previous Clinical Trials
8,379,257 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
499 Patients Enrolled for Non-alcoholic Fatty Liver Disease
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,625 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
292 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

GSK4532990 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05583344 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: High Dose GSK4532990, Low Dose GSK4532990, Placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: GSK4532990 Highlights & Side Effects. Trial Name: NCT05583344 — Phase 2
GSK4532990 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05583344 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05583344 — Phase 2
~69 spots leftby Sep 2025
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