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Monoclonal Antibodies

GSK4532990 for Fatty Liver Disease (SKYLINE 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
Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.
Participant must be 18 to 75 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose (day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate how the drug GSK4532990 is processed in the body and how it affects the liver. The study will also assess the safety and tolerability of the drug. Participants

Who is the study for?
This trial is for adults aged 18 to 75 who have been diagnosed with NASH (a type of fatty liver disease) or are suspected to have it. They must be able to consent to the study and follow its rules, including stable use of any other medications they're on.
What is being tested?
The study is testing GSK4532990's effects in the body and liver, specifically looking at how it's processed and how it works against NASH. Participants will be involved in the study for about 24 weeks.
What are the potential side effects?
While specific side effects aren't listed here, common ones for drugs treating NASH may include gastrointestinal discomfort, headaches, fatigue, itching or skin reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with or suspected to have NASH.
Select...
I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose (day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 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, 3, 4, 6, 8, 12, 24 and 48 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
Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels
Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels
Secondary study objectives
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
Maximum observed concentration (Cmax) of GSK4532990
Percent change from baseline in the observed HSD17B13 mRNA expression levels
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: GSK4532990 Dose 4Experimental Treatment1 Intervention
Participants will receive GSK4532990 Dose 4
Group II: GSK4532990 Dose 3Experimental Treatment1 Intervention
Participants will receive GSK4532990 Dose 3
Group III: GSK4532990 Dose 2Experimental Treatment1 Intervention
Participants will receive GSK4532990 Dose 2
Group IV: GSK4532990 Dose 1Experimental Treatment1 Intervention
Participants will receive GSK4532990 Dose 1

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,807 Previous Clinical Trials
8,381,270 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
697 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~20 spots leftby Jun 2025
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