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FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT04710524•Future Medicine

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Individuals must meet all of the following criteria to be included in the study:
•1. Be able and willing to provide written informed consent to take part in the study, and to comply with all the study's requirements.
•2. Be a man or woman ≥18 years of age at screening.
•3. 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
•4. Serum ALT concentration \>1 × upper limit of normal (ULN) at screening
+15 more criteria

Exclusion Criteria

•Individuals meeting any of the following criteria at screening or baseline are ineligible to participate in this study:
•1. 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.
•2. Female persons who are pregnant, or are breastfeeding at screening, or who plan to become pregnant during the study.
•3. Body mass index (BMI) \<25 kg/m2.
•4. Fibrosis-4 index (FIB-4) \>2.6 at screening.
•5. Any of the following laboratory test abnormalities at screening:
•1. Serum ALT and/or AST concentration \>5 × upper limit of normal (ULN)
•2. 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
•3. Serum albumin concentration ≤3.5 g/dL
•4. International normalized ratio (INR) ≥1.3
+29 more criteria

Locations (12)

Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika

Budapest, Hungary

West Health Kft.,

Budapest, Hungary

Krakowskie Centrum Medyczne sp z o.o.

Krakow, Poland

ID Clinic Arkadiusz Pisula

Mysłowice, Poland

Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Centrum Medyczne K2J2

Wołomin, Poland

Centrum Badan Klinicznych Piotr Napora lekarze

Wroclaw, Poland

Hospital Universitari Vall d Hebron

Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitario Virgen del Rocio (HUVR)

Seville, Spain

Key Dates

Start Date

June 10, 2021

Primary Completion Date

May 31, 2023

Completion Date

August 31, 2023

Last Updated

July 1, 2022

Enrollment

ESTIMATED participants

Conditions

Nonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis

Interventions

Placebo

DRUG

FM101 150 mg BID

DRUG

FM101 300 mg BID

DRUG

Contacts

Saehan Kang, MS

CONTACT

+82232873805 saehan@futuremedicine.co.kr

Kyounghee Kim, MS

CONTACT

+8222898540 kkh@futuremedicine.co.kr

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

NCT02815891

Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects

Hepatic Energy Fluxes in NASH and NAS Patients

Phase 2b Study of GSK4532990 in Adults With NASH