Trials / Withdrawn
WithdrawnNCT06594523
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis (MASH) and F2/F3 Fibrosis (FASCINATE-3)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sagimet Biosciences Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression without the worsening of steatohepatitis.
Detailed description
Approximately 1260 patients (including at least 60% of F3 patients) will be enrolled to receive either denifanstat 50 mg (580 patients), placebo (580 patients), or denifanstat 25 mg (100 patients).
Conditions
- MASH
- NASH
- Metabolic Dysfunction-associated Steatohepatitis
- Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis
- Nonalcoholic Steatohepatitis
- Nonalcoholic Fatty Liver
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denifanstat | Tablet |
| DRUG | Placebo | Matching Tablet |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2030-12-01
- Completion
- 2030-12-01
- First posted
- 2024-09-19
- Last updated
- 2025-05-15
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06594523. Inclusion in this directory is not an endorsement.