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

NCT04710524 | Unknown Phase 2

• 1 other identifier: FM101-CTP2-001
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 12

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

Conditions

Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic Fatty Liver Disease; NAFLD; Nonalcoholic Steatohepatitis; NASH; FM101

Outcome Measures

Primary Outcomes (2)

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

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

  Day 1 through Day 106

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

  Changes in serum ALT level

  Day 1 through Day 91

Secondary Outcomes (1)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

FM101 150 mg BID

EXPERIMENTAL

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

Drug: FM101 150 mg BID

FM101 300 mg BID

EXPERIMENTAL

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

Drug: FM101 300 mg BID

Interventions

Placebo DRUG

Placebo BID for 13 weeks

Placebo

FM101 150 mg BID DRUG

FM101 (150 mg) BID for 13 weeks

FM101 150 mg BID

FM101 300 mg BID DRUG

FM101 (300 mg) BID for 13 weeks

FM101 300 mg BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Undergo MRI-PDFF that demonstrates ≥8% liver steatosis during the screening period.
• Undergo MRE with a score ≥2.9 kPa during the screening period.
• Women of childbearing potential (WoCBP) must have a negative serum beta human chorionic gonadotropin (HCG) test result at screening.
• Female patients must agree to use highly effective birth control throughout the study and up to 30 days after the last dose of study drug has been taken. Highly effective contraception measures include the following, but not limited to:
• Combined estrogen- and progestogen-containing hormonal contraception (oral, intravaginal and transdermal);

You may not qualify if:

• 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/m2.
• 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
• Platelet count less than the lower limit of normal range (LLN)
• Creatinine clearance rate \<60 mL/minute as calculated by the modification of diet in renal disease (MDRD) estimated glomerular filtration rate (eGFR) equation
• Positive COVID-19 polymerase chain reaction (PCR) test result at screening NOTE: Repeat testing of a given parameter or parameters that returned ineligible results, may be performed during the same screening period in consultation with the sponsor's Medical Monitor. An interval of at least 7 days should exist between receipt of the ineligible test result and re-testing.
• Chronic liver disease other than confirmed or suspected NASH, including but not limited to the following diagnoses / entities:
• Chronic hepatitis B virus infection (defined by the presence of hepatitis B surface antigen at screening) and / or chronic hepatitis C virus (HCV) infection (defined by the presence of detectable HCV ribonucleic acid (RNA) antibody \[anti-HCV\] at screening). Patients whose anti-HCV antibody test at screening is positive, but who test negative for HCV RNA at screening will be permitted to participate in the study as long as there has been evidence of viral negativity for at least 24 months prior to screening)

Sponsors & Collaborators

• Future Medicine: lead

Study Sites (12)

Semmelweis Egyetem I. sz. Sebészeti és Intervenciós Gasztroenterológiai Klinika

Budapest, Hungary

RECRUITING

West Health Kft.,

Budapest, Hungary

RECRUITING

Krakowskie Centrum Medyczne sp z o.o.

Krakow, Poland

RECRUITING

ID Clinic Arkadiusz Pisula

Mysłowice, Poland

RECRUITING

Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

RECRUITING

Centrum Medyczne K2J2

Wołomin, Poland

RECRUITING

Centrum Badan Klinicznych Piotr Napora lekarze

Wroclaw, Poland

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Spain

RECRUITING

Hospital Universitario Virgen del Rocio (HUVR)

Seville, Spain

RECRUITING

Consorcio Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Clnico Universitario de Valencia

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• WanSeok Jeong, MBA

  Future Medicine Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Saehan Kang, MS

CONTACT

+82232873805; saehan@futuremedicine.co.kr

Kyounghee Kim, MS

CONTACT

+8222898540; kkh@futuremedicine.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: January 14, 2021
• Study Start: June 10, 2021
• Primary Completion: May 31, 2023
• Study Completion: August 31, 2023
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); HU (2); PL (5)