Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05583344 | Phase 2b Study of GSK4532990 in Adults With NASH | PHASE2 | ACTIVE NOT_RECRUITING | 284 | — | — | Jan 2, 2023 | Apr 5, 2027 | May 22, 2026 | 170 | United States, Argentina +15 |
Improvement in histological fibrosis is assessed with Clinical research network (CRN) Scoring. No worsening of NASH is defined as no increase in the NAFLD Activity Score (NAS) for steatosis, ballooning, or inflammation.
NASH resolution is defined as a ballooning score of 0 and an inflammation score of 0-1. No worsening of fibrosis is defined as no increase in CRN fibrosis score.
| Arm | Type | Description |
|---|---|---|
| High Dose GSK4532990 | EXPERIMENTAL | - |
| Low Dose GSK4532990 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GSK4532990 | DRUG | GSK4532990 will be administered. |
| Placebo | DRUG | Placebo will be administered. |
Inclusion Criteria: * 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 like...