NCT04710524

FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Future Medicine · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Randomized Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of FM101 in Adults with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis

Conditions

• Nonalcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo BID for 13 weeks
DRUG	FM101 150 mg BID	FM101 (150 mg) BID for 13 weeks
DRUG	FM101 300 mg BID	FM101 (300 mg) BID for 13 weeks

Timeline

• Start date: 2021-06-10
• Primary completion: 2023-05-31
• Completion: 2023-08-31
• First posted: 2021-01-14
• Last updated: 2022-07-01

Locations

12 sites across 3 countries: Hungary, Poland, Spain