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Efimosfermin · 2 trials · 3 indications
To assess the effects of efimosfermin on safety and tolerability.
The effects of Efimosfermin on safety and tolerability will be assessed.
The effects of Efimosfermin on safety and tolerability will be assessed.
The effects of Efimosfermin on safety and tolerability will be assessed.
The effects of Efimosfermin on safety and tolerability will be assessed.
| Arm | Type | Description |
|---|---|---|
| Efimosfermin (Dose 1) | EXPERIMENTAL | Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W). |
| Efimosfermin (Dose 2) | EXPERIMENTAL | Participants will receive efimosfermin (Dose 2) Q4W. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo Q4W. |
| Cohort A1: Efimosfermin Dose 1 or placebo (PBO) | EXPERIMENTAL | - |
| Cohort A2: Efimosfermin Dose 2 or PBO | EXPERIMENTAL | - |
| Cohort A3: Efimosfermin Dose 3 or PBO | EXPERIMENTAL | - |
| Cohort A4: Efimosfermin Dose 4 or PBO | EXPERIMENTAL | - |
| Cohort A5: Efimosfermin Dose 5 or PBO | EXPERIMENTAL | - |
| Part B: Efimosfermin Dose 1 or PBO | EXPERIMENTAL | - |
| Part C: Efimosfermin Dose 1 | EXPERIMENTAL | - |
| Part D: Efimosfermin Dose 6 or PBO | EXPERIMENTAL | - |
| Part D: Efimosfermin Dose 1 or PBO | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Efimosfermin | DRUG | Efimosfermin will be administered as a subcutaneous injection. |
| Placebo | DRUG | Placebo will be administered as a subcutaneous injection. |
Inclusion Criteria: * Ability to understand and sign a written informed consent form (ICF) * Age 18 through 75 years at enrollment * History or presence of 2 or more of the 5 components of metabolic syndrome * Liver biopsy confirmation of MASH consistent with stage F4 fibrosis * Other inclusion cri...
Efimosfermin is an investigational small molecule being developed for Nonalcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-Associated Steatohepatitis (MASH). It is being studied in patients with biopsy-confirmed NASH or MASH, including those with compensated cirrhosis due to MASH.
Efimosfermin is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials of the drug in the United States for Nonalcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-Associated Steatohepatitis (MASH).
Efimosfermin is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials are listed: one completed study and one actively recruiting study in patients with MASH-related cirrhosis.
Efimosfermin is being studied in two Phase 2 trials. NCT04880031, a completed study in obese subjects at risk for or with biopsy-confirmed NASH, enrolled 231 participants. NCT06920043, currently recruiting, is studying the drug in 42 participants with biopsy-confirmed compensated cirrhosis due to MASH.
Efimosfermin is the same drug as BOS-580. The completed Phase 2 trial NCT04880031 was titled 'A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension,' and the drug is now referred to as Efimosfermin in later trials.