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Phase 2b Study of GSK4532990 in Adults with NASH (HORIZON)
EU CTIS ID: 2023-507503-62-00
What this study is testing
To evaluate whether GSK4532990 can cause one (or both) of fibrosis regression and/or NASH resolution in participants with NASH and bridging (F3) fibrosis
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Korea, Republic of
- Argentina
- Panama
- United Kingdom
- India
- Mexico
- United States
- Australia
- Turkey
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Korea, Republic of; Argentina; Panama; United Kingdom; India and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.