WithdrawnPhase 3

A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH

Stopped: Business decision

0Started 2025-03

Plain-language summary

A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. T2DM
✓. At least 2 out of 4 of the following:
✓. HbA1c ≤9.5%
✓. If treatment naive: patients must have been diagnosed for at least 12 weeks prior to screening

Exclusion criteria

✕. ALT and/or AST \>5 × ULN.
✕. ALP ≥2 × ULN.
✕. Total serum bilirubin concentration \>1.3 mg/dL.
✕. Serum albumin concentration \<3.5 g/dL.
✕. International normalized ratio (INR) \>1.3, except for patients receiving anticoagulant treatment.
✕. Platelet count \<140,000/μL.
✕. Fasting TG level ≥500 mg/dL.
✕. eGFR \<45 mL/min/1.73 m2.

What they're measuring

Primary Safety Outcome Measure: TEAEs

Timeframe: 52 weeks

Trial details

NCT IDNCT06692283

SponsorSagimet Biosciences Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More MASLD trials