Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Semaglutide · 2 trials · 1 indication
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off.
Treatment-emergent adverse events (TEAEs) were defined as, any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants were assessed for AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post-baseline up to and including the date of last dose of study drug plus 30 days, were summarized by treatment group. Graded laboratory abnormalities were defined using the grading scheme in the CTCAE 5.0.
| Arm | Type | Description |
|---|---|---|
| SEMA + CILO/FIR FDC | EXPERIMENTAL | Participants will receive semaglutide (SEMA) 3.0 mg/mL, once weekly and cilofexor and firsocostat (CILO/FIR) 30 mg/20 mg fixed-dose combination (FDC) tablet, once daily up to 72 weeks. |
| SEMA + PTM CILO/FIR | EXPERIMENTAL | Participants will receive SEMA 3.0 mg/mL, once weekly and Placebo-To-Match (PTM) CILO/FIR FDC tablet, once daily up to 72 weeks. |
| PTM SEMA + CILO/FIR FDC | EXPERIMENTAL | Participants will receive PTM SEMA, once weekly and CILO/FIR 30 mg/20 mg FDC tablet, once daily up to 72 weeks. |
| PTM SEMA + PTM CILO/FIR | PLACEBO_COMPARATOR | Participants will receive PTM SEMA, once weekly and PTM CILO/FIR FDC tablet, once daily up to 72 weeks. |
| Semaglutide | EXPERIMENTAL | Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) for 24 weeks |
| Semaglutide + Firsocostat 20 mg | EXPERIMENTAL | Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + firsocostat 20 mg for 24 weeks |
| Semaglutide + Cilofexor 30 mg | EXPERIMENTAL | Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + cilofexor 30 mg for 24 weeks |
| Semaglutide + Cilofexor 100 mg | EXPERIMENTAL | Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + cilofexor 100 mg for 24 weeks |
| Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | EXPERIMENTAL | Semaglutide 0.24 mg - 2.4 mg (dose escalated over 16 weeks) + firsocostat 20 mg + cilofexor 30 mg for 24 weeks |
| Name | Type | Description |
|---|---|---|
| Semaglutide (SEMA) | DRUG | Administered as subcutaneous (SC) injection |
| Cilofexor (CILO)/Firsocostat (FIR) | DRUG | Tablets administered orally |
| PTM SEMA | DRUG | Administered as SC injection |
| PTM CILO/FIR | DRUG | Tablets administered orally |
| Semaglutide | DRUG | Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly |
| Firsocostat | DRUG | Tablets administered orally once daily |
| Cilofexor | DRUG | Tablets administered orally once daily |
Key Inclusion Criteria: * Liver biopsy consistent with cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH) in the opinion of the central reader. In individuals who have never had a liver biopsy, a screening liver biopsy may be performed. * Screening laboratory parameters as determined by the ...
Semaglutide is being investigated as a treatment for Nonalcoholic Steatohepatitis (NASH). It is in Phase 2 clinical development for this condition. The drug is being studied both as a monotherapy and in combination with other agents to evaluate its safety, tolerability, and efficacy in adults with NASH, including those with cirrhosis.
Semaglutide is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Nonalcoholic Steatohepatitis.
Semaglutide is currently in Phase 2 clinical development for Nonalcoholic Steatohepatitis. Two Phase 2 trials have been completed, with a total of 566 participants enrolled across studies. The drug remains investigational and has not yet been approved for this indication.
Semaglutide has been studied in two completed Phase 2 clinical trials. The first trial, NCT03987074, enrolled 109 participants in the United States to evaluate monotherapy and combination regimens in NASH. The second trial, NCT04971785, enrolled 457 participants across multiple countries to study semaglutide alone and in combination with cilofexor/firsocostat in adults with cirrhosis due to NASH.
Semaglutide is a small molecule being developed for Nonalcoholic Steatohepatitis. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated for its effects on liver-related outcomes in patients with NASH.
Semaglutide is being studied as a distinct investigational agent for Nonalcoholic Steatohepatitis. In clinical trials, it has been evaluated both alone and in combination with cilofexor and firsocostat, which are separate drugs. No alternative names for semaglutide have been reported in the trial data.