Drugs / Pegbelfermin

Trials 12

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT04649710 Jun → Sep 2021 — Bristol-Myers Squibb Withdrawn No outcome recorded Stop: Business
Phase 1 NCT04634149 Nov 2020 → Jun 2022 liver disorder Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT04493567 Jul 2020 → Jun 2021 — Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT03674476 Sep 2018 → Jun 2019 NAFLD1, metabolic dysfunction-associated steatohepatitis Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT03445208 Feb → May 2018 NAFLD1, cirrhosis of liver, fibrotic liver disease, metabolic dysfunction-associated steatohepatitis Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT03198182 Jun → Sep 2017 metabolic disease Bristol-Myers Squibb Completed No outcome recorded
Phase 25 trials · 1 met primary · 3 missed
Phase 2 NCT03486899 Jun 2018 → Sep 2020 NAFLD1, fibrotic liver disease, metabolic dysfunction-associated steatohepatitis Bristol-Myers Squibb Completed Missed primary
Phase 2 NCT03486912 Jun 2018 → Oct 2020 NAFLD1, cirrhosis of liver, fibrotic liver disease, metabolic dysfunction-associated steatohepatitis Bristol-Myers Squibb Completed Missed primary
Phase 2 NCT02413372 May 2015 → Jan 2017 metabolic dysfunction-associated steatohepatitis Bristol-Myers Squibb Completed Met primary
Phase 2 NCT03400163 May 2015 → Jan 2017 metabolic dysfunction-associated steatohepatitis Bristol-Myers Squibb Completed No outcome recorded
Phase 2 NCT02097277 Apr 2014 → Sep 2015 type 2 diabetes mellitus Bristol-Myers Squibb Completed Missed primary
Phase not stated1 trial
— NCT03611101 May 2018 → Aug 2020 metabolic dysfunction-associated steatohepatitis Meridian Bioscience, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2017-10-20 Bristol-Myers Squibb Results Bristol-Myers Squibb to Present New Data Advancing Research Across Serious Liver Diseases at The Liver Meeting® 2017 bms.com ↗
New analyses from a Phase 2 study of BMS-986036 (pegylated FGF21) in NASH further support non-invasive methods for assessing liver fibrosis
2017-04-22 Bristol-Myers Squibb Results Bristol-Myers Squibb’s BMS-986036 (Pegylated FGF21) Shows Consistent Improvement in Liver Fat, Liver Injury and Fibrosis in Patients with Nonalcoholic Steatohepatitis (NASH) in Phase 2 Trial bms.com ↗
The study achieved its primary endpoint of significant reduction in liver fat versus placebo.

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Pegbelfermin “This study assessed pegbelfermin (BMS-986036), recombinant PEGylated human fibroblast growth factor 21 (FGF21), in patients with obesity and T2DM predisposed to fatty liver.” PMID 30520566 ↗ Dec 2018
Known as ARX-618 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297578 ↗
Known as BMS-986036 “This study assessed pegbelfermin (BMS-986036), recombinant PEGylated human fibroblast growth factor 21 (FGF21), in patients with obesity and T2DM predisposed to fatty liver.” PMID 30520566 ↗ Dec 2018
11

NCT03198182 ↗

NCT03445208 ↗

NCT02413372 ↗

NCT03486899 ↗

NCT03674476 ↗

NCT04649710 ↗

NCT04493567 ↗

NCT04634149 ↗

NCT03400163 ↗

NCT03611101 ↗

Show 1 more source

Known as PEG-FGF21 “A Phase 2B Randomized Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and...” NCT03486899 ↗
Known as Pegbelfermina ChEMBL registry synonym — accepted as the source's own label CHEMBL4297578 ↗
Known as Pegbelfermine ChEMBL registry synonym — accepted as the source's own label CHEMBL4297578 ↗
Modality Protein / enzyme biologic “recombinant PEGylated human fibroblast growth factor 21 (FGF21)” PMID 30520566 ↗ Dec 2018
Route Subcutaneous “BMS-986036 1 mg subcutaneous injection once daily for 12 weeks” NCT02097277 ↗