NCT04004325

A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis

A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Efficacy of FT-4101 in Overweight/Obese Subjects With NASH

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Forma Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts.

Conditions

• Nonalcoholic Steatohepatitis (NASH)
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	FT-4101	FT-4101 will be supplied as active capsules and will be administered per the protocol defined frequency and dose level.
DRUG	FT-4101 placebo	FT-4101 placebo will be supplied as placebo capsule matching in size and color to all the active capsules and will be administered per the protocol defined frequency and dose level.
OTHER	Deuterated Water	Deuterated water will be provided as individual ready-to-use, single dose bottles each containing 50 mL of deuterated water (70%).

Timeline

• Start date: 2019-05-17
• Primary completion: 2020-01-20
• Completion: 2020-01-20
• First posted: 2019-07-02
• Last updated: 2025-10-20
• Results posted: 2024-11-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study