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Monoclonal Antibodies

GSK4532990 Dose 1 for Non-alcoholic 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

SKYLINE Trial 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.Check my eligibility

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.See study design

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.

SKYLINE Trial 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.

SKYLINE Trial Timeline

Screening ~ 3 weeks3 visits

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

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

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

Primary outcome measures

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 outcome measures

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

SKYLINE 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,768 Total Patients Enrolled

7 Trials studying Non-alcoholic Fatty Liver Disease

697 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

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

Are there any available vacancies for patient participation in this clinical trial?

"Based on the information provided by clinicaltrials.gov, this particular clinical trial is not currently in the recruitment phase. The trial was initially posted on January 18th, 2024 and last updated on January 10th, 2024. However, it's important to note that there are currently 371 other ongoing clinical trials actively seeking participants."

Answered by AI

In how many different geographical areas can patients access this clinical trial?

"Currently, this clinical trial is enrolling participants from a total of 8 locations. These sites are spread across various cities including Chula Vista, Montclair, and Miami Lakes among others. When considering enrollment, it would be beneficial to select the site closest to your location in order to minimize travel obligations."

Answered by AI

Has the FDA given its approval for Dose 4 of GSK4532990?

"Given that this trial is in Phase 2, our team at Power rates the safety of GSK4532990 Dose 4 as a 2. While there is limited evidence supporting its safety, no data has yet been collected regarding efficacy."

Answered by AI

Could individuals younger than 60 years old be considered as potential candidates for participation in this clinical trial?

"To be eligible for enrollment in this clinical trial, patients must fall within the age range of 18 to 75 years. It is noteworthy that there are 31 trials available specifically for individuals under the age of 18 and 324 trials catered towards those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Exploration Study of GSK4532990 in Participants With NASH or Suspected NASH

2024. "Dose Exploration Study of GSK4532990 in Participants With NASH or Suspected NASH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06104319.

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