Clinical trial NCT06104319: Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: GSK4532990
Non-alcoholic steatohepatitis (NASH)
Non-alcoholic fatty liver disease (NAFLD)
Suspected NASH
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-10-27
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 24-36 weeks.


Eligibility criteria: 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®.

Primary outcomes:
measure: Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels
timeFrame: Baseline (Day 1) and up to Week 28
measure: Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels
timeFrame: Baseline (Day 1) and up to Week 28
Secondary outcomes:
measure: Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
timeFrame: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose
measure: Maximum observed concentration (Cmax) of GSK4532990
timeFrame: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose
measure: Percent change from baseline in the. observed HSD17B13 protein expression. levels
timeFrame: Baseline and Weeks 8, 12, or 28 post-dose
measure: Percent change from baseline in the. observed HSD17B13 mRNA expression. levels
timeFrame: Baseline and Weeks 8, 12, or 28 post-dose
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: GSK Investigational Site
state: California
city: Montclair
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Brandon
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: El Dorado
country: United States
facility: GSK Investigational Site
state: Kansas
city: Marrero
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
References: