11 completed, 1 withdrawn. 6 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 5, Withdrawn 1 |
| Phase 2 | 5 | Completed 5 |
Follow Pegbelfermin: new trials by email Literature Review of Pegbelfermin trials Research Report on Pegbelfermin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants BMS-986036, Placebo - Healthy Participants | Phase 1 | Withdrawn | Bristol-Myers Squibb | 2021-06-21 | 2022-04-28 | |
| 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 BMS-986036 - Moderate Liver Impairment, Severe Liver Impairment | Phase 1 | Completed | Bristol-Myers Squibb | 16 | 2020-11-23 | 2022-06-16 |
| Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe BMS-986036 - Healthy Participants | Phase 1 | Completed | Bristol-Myers Squibb | 102 | 2020-07-29 | 2022-03-18 |
| An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function BMS-986036 - NAFLD, Nonalcoholic Fatty Liver Disease | Phase 1 | Completed | Bristol-Myers Squibb | 40 | 2018-09-11 | 2019-10-08 |
| A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis BMS-986036, Placebo - Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD) | Phase 2 | Completed | Bristol-Myers Squibb | 197 | 2018-06-19 | 2022-09-09 |
| A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis BMS-986036, Placebo - Hepatic Cirrhosis, Liver Fibrosis | Phase 2 | Completed | Bristol-Myers Squibb | 155 | 2018-06-12 | 2022-10-13 |
| Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials ¹³C-Methacetin Breath Test, BMS-986036, BreathID MCS device - NASH - Nonalcoholic Steatohepatitis | Completed | Meridian Bioscience, Inc. | 124 | 2018-05-04 | 2022-12-20 | |
| A Study of Experimental Medication BMS-986036 Given to Healthy Participants BMS-986036 - Hepatic Cirrhosis, Liver Fibrosis | Phase 1 | Completed | Bristol-Myers Squibb | 30 | 2018-02-14 | 2020-03-19 |
| A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects Placebo, BMS-986036 - Metabolics | Phase 1 | Completed | Bristol-Myers Squibb | 63 | 2017-06-28 | 2019-05-01 |
| A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH) BMS-986036, Placebo - Non-Alcoholic Steatohepatitis | Phase 2 | Completed | Bristol-Myers Squibb | 184 | 2015-05-08 | 2021-02-26 |
| A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH) BMS-986036, Placebo - Non-Alcoholic Steatohepatitis | Phase 2 | Completed | Bristol-Myers Squibb | 3 | 2015-05-08 | 2021-02-26 |
| A Study to Evaluate BMS-986036 in Obese Adults With Type-2 Diabetes BMS-986036, Placebo (Matching with BMS-986036) - Diabetes Mellitus Type 2 | Phase 2 | Completed | Bristol-Myers Squibb | 219 | 2014-04-15 | 2019-07-31 |
Non-alcoholic Fatty Liver Disease (8) · Liver Cirrhosis (3) · Diabetes Mellitus, Type 2 (1) · Fibrosis (1) · Obesity (1) · Overweight (1)
Bristol-Myers Squibb (11) · Meridian Bioscience, Inc. (1)
United States (10) · Japan (2) · Canada (1) · China (1) · Czechia (1) · Hungary (1) · South Korea (1)
PMID 33657443, PMID 30520566, PMID 30554783, PMID 36866389, PMID 37088457, PMID 37088458
2018 (1)