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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 non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH), and alcohol-related liver disease. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.
GSK4532990 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting multiple Phase 2 trials to evaluate the drug's safety and efficacy in liver disease indications.
GSK4532990 is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. The company is conducting several Phase 2 trials, including a Phase 2b study in adults with NASH and a dose exploration study in participants with NASH.
GSK4532990 is being studied in three Phase 2 trials: NCT05583344, a Phase 2b study in adults with NASH (active, not recruiting); NCT06104319, a dose exploration study in participants with NASH (completed); and NCT06613698, a study comparing GSK4532990 with placebo in adults with alcohol-related liver disease (recruiting).
GSK4532990 is a distinct investigational compound developed by GSK plc. It is not known to be the same as any other marketed drug. Its mechanism of action has not been publicly disclosed in the available clinical trial information.