BMS-986036

DRUG12 trials

Sponsors

Bristol-Myers Squibb, Meridian Bioscience, Inc.

Conditions

Diabetes Mellitus Type 2Healthy ParticipantsHepatic CirrhosisLiver FibrosisMetabolicsModerate Liver ImpairmentNAFLDNASH - Nonalcoholic Steatohepatitis

Phase 1

A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects

CompletedNCT03198182

Bristol-Myers SquibbMetabolics

Start: 2017-06-28End: 2017-09-22Updated: 2019-05-01

A Study of Experimental Medication BMS-986036 Given to Healthy Participants

CompletedNCT03445208

Bristol-Myers SquibbHepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease +1

Start: 2018-02-14End: 2018-05-02Updated: 2020-03-19

An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function

CompletedNCT03674476

Bristol-Myers SquibbNAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Start: 2018-09-11End: 2019-06-24Updated: 2019-10-08

Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

CompletedNCT04493567

Bristol-Myers SquibbHealthy Participants

Start: 2020-07-29End: 2021-06-11Updated: 2022-03-18

A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment

CompletedNCT04634149

Bristol-Myers SquibbModerate Liver Impairment, Severe Liver Impairment

Start: 2020-11-23End: 2022-06-02Updated: 2022-06-16

A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants

WithdrawnNCT04649710

Bristol-Myers SquibbHealthy Participants

Start: 2021-06-21End: 2021-09-22Updated: 2022-04-28

Phase 2

A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes

CompletedNCT02097277

Bristol-Myers SquibbDiabetes Mellitus Type 2

Start: 2014-04-15End: 2016-05-17Updated: 2019-07-31

A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

CompletedNCT02413372

Bristol-Myers SquibbNon-Alcoholic Steatohepatitis

Start: 2015-05-08End: 2017-06-19Updated: 2021-02-26

A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

CompletedNCT03400163

Bristol-Myers SquibbNon-Alcoholic Steatohepatitis

Start: 2015-05-08End: 2017-06-19Updated: 2021-02-26

A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

CompletedNCT03486899

Bristol-Myers SquibbLiver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis

Start: 2018-06-19End: 2021-08-17Updated: 2022-09-09

A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

CompletedNCT03486912

Bristol-Myers SquibbHepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD) +1

Start: 2018-06-12End: 2021-09-14Updated: 2022-10-13

Unknown Phase

Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials

CompletedNCT03611101

Meridian Bioscience, Inc.NASH - Nonalcoholic Steatohepatitis

Start: 2018-05-04End: 2021-11-10Updated: 2022-12-20

Related Papers

Pegbelfermin in Patients With Nonalcoholic Steatohepatitis and Compensated Cirrhosis (FALCON 2): A Randomized Phase 2b Study.

2023-04-2364 citations

Pegbelfermin in Patients With Nonalcoholic Steatohepatitis and Stage 3 Fibrosis (FALCON 1): A Randomized Phase 2b Study.

2023-04-2356 citations

Effect of pegbelfermin on NASH and fibrosis-related biomarkers and correlation with histological response in the FALCON 1 trial.

2023-01-0721 citations

Pegbelfermin selectively reduces secondary bile acid concentrations in patients with non-alcoholic steatohepatitis.

2021-11-1212 citations

The FALCON program: Two phase 2b randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of pegbelfermin in the treatment of patients with nonalcoholic steatohepatitis and bridging fibrosis or compensated cirrhosis.

2021-02-2850 citations

Pegbelfermin (BMS-986036), a PEGylated fibroblast growth factor 21 analogue, in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 2a trial.

2018-12-13386 citations