Phase 2b Study of GSK4532990 in Adults with NASH (HORIZON)
- Conditions
- on-alcoholic Fatty Liver DiseaseTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-507503-62-00
- Lead Sponsor
- Glaxosmithkline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 258
Participant must be 18 to 75 years of age inclusive, at the time of screening., Body Mass Index (BMI) =25 kilogram per meter square (kg/m^2) (all ethnic origins) except for Asian participants who qualify for the study with BMI =23 kg/m2 at Screening., In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension., The liver biopsy must show a NAS =4 with at least 1 point each in steatosis, inflammation, and ballooning and Fibrosis 3 using NASH CRN Scoring System, confirmed by central scoring., Capable of giving signed informed consent prior to the performance of any study-specific procedures, Able and willing to comply with all study assessments., A female participant is eligible to participate, if she is not pregnant or breastfeeding and one of the following conditions applies: • Is a woman of nonchildbearing potential (WONCBP) as defined in Section 10.4 Contraception and Barrier Guidance OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4. Contraceptive measures must start from the time of negative serum pregnancy test at screening and at least 28 days before first administration of study intervention. Contraceptive measures should then continue during the study intervention period, and for at least 18 weeks after the last administration of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention). o A WOCBP must have a negative highly sensitive pregnancy test (serum or urine as required by local regulations) within 24 hours before the first dose of study intervention, see Section 8.2.5 Pregnancy Testing.
Current alcohol consumption =14 standard drinks (24 units, 196 g ethanol) per week for females or =21 standard drinks (37 units, 294g ethanol) per week for males. One standard drink is equivalent to: 12 US fluid ounces (oz) beer (5% alcohol); 5 oz of wine (12% alcohol), or 1.5 oz of 80 proof spirits (40% alcohol)., Weight reduction surgery (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1., History of cancer within previous 2 years from Screening 1, except adequately
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method