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
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
- DRUG
-
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
-
A Phase 2b Study of Icosabutate in Fatty Liver Disease
NCT04052516 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
NCT04171765 ·Status: TERMINATED ·Phase: PHASE2
-
Nonalcoholic Fatty Liver Disease (NAFLD) Pharmacological Treatment: Metformin Versus Atorvastatin
NCT01544751 ·Status: UNKNOWN ·Phase: NA
-
A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease
NCT01277094 ·Status: COMPLETED ·Phase: PHASE1
-
Non Alcoholic Fatty Liver Disease Influence of Statin Therapy
NCT00375349 ·Status: WITHDRAWN ·Phase: NA
-
Ursodeoxycholic Acid in Patients With NAFLD - Clinical Observation
NCT05256979 ·Status: ACTIVE_NOT_RECRUITING
-
A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03350165 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease
NCT04766476 ·Status: TERMINATED ·Phase: PHASE1
-
A Research Study of a Potential New Medicine (NNC4005-0001) for Liver Disease in Adult Participants With Increased Body Weight and Liver Fat
NCT07214870 ·Status: RECRUITING ·Phase: PHASE1
-
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
NCT05364684 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Healthy Adults Evaluating PF-07202954
NCT04857437 ·Status: COMPLETED ·Phase: PHASE1
-
6-week Safety and PD Study in Adults With NAFLD
NCT03256526 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NCT04849728 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD
NCT02941549 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients
NCT01999101 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03248882 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
NCT02316717 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
NCT02548351 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease
NCT02927314 ·Status: COMPLETED ·Phase: PHASE2
-
FTIH of ECC4703 in Healthy Volunteers
NCT05552274 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Study to Evaluate MET642 in Patients With NASH
NCT04773964 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
NCT04505436 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Fecal Microbiota Transplantation (FMT) in Nonalcoholic Steatohepatitis(NASH). A Pilot Study
NCT02469272 ·Status: UNKNOWN ·Phase: PHASE1
-
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
NCT04006145 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction
NCT05478603 ·Status: COMPLETED ·Phase: PHASE1