Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK4532990 · 3 trials · 3 indications
Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device.
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
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 |
|---|---|---|
| GSK4532990 Dose 1 | EXPERIMENTAL | - |
| GSK4532990 Dose 2 | EXPERIMENTAL | - |
| GSK4532990 Dose 3 | EXPERIMENTAL | - |
| GSK4532990 Dose 4 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| High Dose GSK4532990 | EXPERIMENTAL | - |
| Low Dose GSK4532990 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| GSK4532990 | DRUG | GSK4532990 will be administered |
| Placebo | DRUG | Placebo will be administered |
Inclusion Criteria: * Capable of giving signed informed consent prior to the performance of any study-specific procedures. * Able and willing to comply with all study assessments and adhere to the protocol schedule of activities. * In the opinion of the investigator, there is a history of alcohol c...
GSK4532990 is an investigational small molecule being studied for nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), and alcohol-related liver disease. It is currently in Phase 2 clinical development for these liver conditions.
GSK4532990 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting multiple Phase 2 trials of the drug in liver disease indications.
GSK4532990 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Active and completed Phase 2 trials are evaluating its safety and efficacy in NASH and alcohol-related liver disease.
GSK4532990 is being studied in several Phase 2 trials. NCT05583344 is a Phase 2b study in adults with NASH with 284 participants. NCT06104319 is a completed dose exploration study in NASH. NCT06613698 is a recruiting study comparing GSK4532990 to placebo in alcohol-related liver disease with 393 participants.
Yes, GSK4532990 is being studied in alcohol-related liver disease. Trial NCT06613698 is a Phase 2 study recruiting adults aged 18 to 70 with this condition. The trial is placebo-controlled and enrolls participants across multiple countries including the United States, United Kingdom, and Japan.
The GSK4532990 clinical program includes trials with varying enrollment. The Phase 2b NASH study NCT05583344 enrolls 284 participants, the dose exploration study NCT06104319 enrolled 61 participants, and the alcohol-related liver disease study NCT06613698 aims to enroll 393 participants.