Clinical Trials/NCT04710524

NCT04710524

Unknown

Phase 2

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

Future Medicine12 sites in 3 countries60 target enrollmentJune 10, 2021

ConditionsNonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

InterventionsFM101 300 mg BID Placebo FM101 150 mg BID

DrugsPlacebo FM101 150 mg BID FM101 300 mg BID

Overview

Phase: Phase 2
Intervention: FM101 300 mg BID
Conditions: Nonalcoholic Fatty Liver Disease
Sponsor: Future Medicine
Enrollment: 60
Locations: 12
Primary Endpoint: To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with NAFLD or NASH
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

June 10, 2021

End Date

August 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Future Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Individuals must meet all of the following criteria to be included in the study:
•Be able and willing to provide written informed consent to take part in the study, and to comply with all the study's requirements.
•Be a man or woman ≥18 years of age at screening.
•Have c. Histologic confirmation of NASH no more than 12 months before the screening visit date, demonstrating the existence of steatosis ≥5%, hepatocyte ballooning and chronic inflammation (at least 1 point for each component), and stage 1 through stage 3 liver fibrosis according to the NASH Clinical Research Network (CRN); OR d. NAFLD based upon demonstration of at least 3 of the following 5 components of the metabolic syndrome below, at screening:
•Fasting plasma glucose ≥100 mg/dL , or undergoing drug treatment for elevated plasma glucose concentrations
•High-density lipoprotein-cholesterol (HDL-c) concentration \<40 mg/dL in male patients, or \<50 mg/dL in female patients, or undergoing drug treatment for reduced serum HDL-c concentrations
•Serum triglyceride (TG) concentration ≥150 mg/dL, or undergoing drug treatment for elevated serum TG concentrations
•Waist circumference \>102 cm in male patients or \>88 cm in female patients
•Systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥85 mm Hg, or undergoing drug treatment for hypertension, or antihypertensive drug treatment in a patient with a history of systemic hypertension
•Serum ALT concentration \>1 × upper limit of normal (ULN) at screening

Exclusion Criteria

•Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
•Any patient who refuses to provide written informed consent to take part in the study, and/or appears unwilling to comply with study-specific requirements.
•Female persons who are pregnant, or are breastfeeding at screening, or who plan to become pregnant during the study.
•Body mass index (BMI) \<25 kg/m
•Fibrosis-4 index (FIB-4) \>2.6 at screening.
•Any of the following laboratory test abnormalities at screening:
•Serum ALT and/or AST concentration \>5 × upper limit of normal (ULN)
•Total serum bilirubin (BR) concentration \>ULN; if an established diagnosis of Gilbert's syndrome exists and the direct serum BR result at screening is less than or equal to ULN the patient may participate in the study
•Serum albumin concentration ≤3.5 g/dL
•International normalized ratio (INR) ≥1.3

Arms & Interventions

FM101 300 mg BID

orally administer FM101 300mg BID for 13 weeks except on Day 91 subject receive a single dose

Intervention: FM101 300 mg BID

Placebo

orally administer placebo BID for 13 weeks except on Day 91 subject receive a single dose

Intervention: Placebo

FM101 150 mg BID

orally administer FM101 150mg BID for 13 weeks except on Day 91 subject receive a single dose

Intervention: FM101 150 mg BID

Outcomes

Primary Outcomes

To assess the safety and tolerability of 13 weeks of treatment with FM101 in patients with NAFLD or NASH

Time Frame: Day 1 through Day 106

The number of TEAEs (frequency of occurrence, number of subjects experiencing the event)

To assess the treatment effect of FM101 on serum ALT concentrations during 13 weeks of treatment

Time Frame: Day 1 through Day 91

Changes in serum ALT level

Secondary Outcomes

To assess the effect of 13 weeks of treatment with FM101 on the change in liver stiffness (kPa) measured by magnetic resonance imaging-magnetic resonance elastography (MRI MRE) in patients with NAFLD or NASH(Day 1 through Day 91)