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

NCT04710524 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Future Medicine

    lead INDUSTRY

Principal Investigators

  • WanSeok Jeong, MBA · Future Medicine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2023-05-31
Completion
2023-08-31

Countries

  • Hungary
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04710524 on ClinicalTrials.gov