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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

Awards & highlights

HORIZON Trial Summary

This trial will measure liver health improvements in people with NASH and advanced fibrosis treated with GSK4532990 compared to a placebo. It will last up to 76 weeks.

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.Check my eligibility

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.See study design

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.

HORIZON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose (day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

HORIZON 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,753 Previous Clinical Trials

8,069,212 Total Patients Enrolled

7 Trials studying Non-alcoholic Fatty Liver Disease

499 Patients Enrolled for Non-alcoholic Fatty Liver Disease

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,684 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any adverse effects to administering Low Dose GSK4532990?

"Our risk assessment at Power has assigned GSK4532990 a safety rating of 2, as the existing clinical data confirms its relative security but falls short of demonstrating efficacy."

Answered by AI

How many participants are involved in this clinical trial?

"Affirmative. Clinicaltrials.gov has the details of this medical study, which was launched on January 2nd 2023, and it is actively enrolling participants. A total of 246 individuals need to be recruited from two distinct sites."

Answered by AI

Is the age limit for participants in this experiment set beyond thirty?

"This clinical trial necessitates that participants must be between 18 and 75 years of age. There are 29 studies for those under the legal age and 316 studies involving individuals over 65."

Answered by AI

Is this research actively recruiting participants?

"Affirmative. According to clinicaltrials.gov, the trial originally posted on January 2nd 2023 is actively seeking participants. The latest update was February 8th 2023 and 246 individuals are required between two medical facilities."

Answered by AI

Is my eligibility to join this clinical research project in any way feasible?

"This clinical trial is looking for 246 individuals, aged between 18 and 75, who are suffering from non-alcoholic fatty liver disease. Participants must also meet the following criteria: have a BMI of 25 kg/m^2 or more (or 23 kg/m^2 if Asian), demonstrate features associated with metabolic syndrome as judged by the investigator, present an NAS score >=4 with at least 1 point each in steatosis, inflammation and ballooning; Fibrosis CRN score should be 3., agree to attend all assessments required for participation in this study including a Week 52 biopsy.."

Answered by AI

Who else is applying?

What state do they live in?

New Jersey

Texas

What site did they apply to?

GSK Investigational Site

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I havexbeen warned by my primary care doc several times. I need to make sure I protect my liver after being diagnosed with NAFLD.

PatientReceived 1 prior treatment

I'm hoping this clinical trial will address and held with my condition. I am hoping to find a cure for liver damage, I want to avoid Dialysis anytime soon.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Phase 2b Study of GSK4532990 in Adults With NASH

2023. "Phase 2b Study of GSK4532990 in Adults With NASH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05583344.

All > Fatty Liver Disease > Nash