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

Non-alcoholic Fatty Liver Disease Clinical Trial

— SKYLINE  

Official title:

A Phase 2a, Single Dose, Open-label, Dose Exploration Study to Assess the PK-PD Activity, Safety, and Tolerability of GSK4532990 in Adult Participants With NASH or Suspected NASH

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104319
• Other study ID #: 218675
• Status: Recruiting
• Phase: Phase 2
• Start date: January 22, 2024
• Est. completion date: June 27, 2025

Study information

• Verified date: March 2024
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 27, 2025
• Est. primary completion date: June 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participant must be 18 to 75 years of age.

• Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.

• Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.

• Participants must meet predefined stable use requirements of concomitant medications based on study criteria.

Exclusion Criteria:

Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:

• Cirrhosis or current unstable liver or biliary disease.

• Other causes of liver disease including, but not limited to, alcohol-related liver disease, autoimmune disorders.

• Known weight loss of =5% within 3 months prior to Screening.

• Weight reduction surgery or procedures within 2 years of Screening.

• Any contraindication to undergoing liver biopsy.

• Any contraindication to undergoing Magnetic Resonance Imaging or FibroScan®.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• GSK4532990
GSK4532990 will be administered

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Chula Vista	California
United States	GSK Investigational Site	Chula Vista	California
United States	GSK Investigational Site	El Dorado	Kansas
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Marrero	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami Lakes	Florida
United States	GSK Investigational Site	Montclair	California
United States	GSK Investigational Site	Morehead City	North Carolina
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels		Baseline (Day 1) and up to Week 16
Primary	Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels		Baseline (Day 1) and up to Week 16
Secondary	Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990		Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose
Secondary	Maximum observed concentration (Cmax) of GSK4532990		Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose
Secondary	Percent change from baseline in the observed HSD17B13 protein expression levels		Baseline and Weeks 8, 12, or 16 post-dose
Secondary	Percent change from baseline in the observed HSD17B13 mRNA expression levels		Baseline and Weeks 8, 12, or 16 post-dose