Adults 18 to 75, any sex, with Hepatic Cirrhosis or Liver Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48Primary· From first dose to 48 weeks after first dose
An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage.
Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score.
Group
Value
95% CI
BMS-986036 10 mg
28.2
BMS-986036 20 mg
24.3
BMS-986036 40 mg
28.2
Placebo
30.8
The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48Secondary· From first dose to 48 weeks after first dose
An improvement in Ishak fibrosis is defined as a decrease of fibrosis by ≥ 1-stage in the Ishak fibrosis score at week 48 in liver biopsy. ISHAKs uses a 0-6 scale: 1: centrilobular pericellular fibrosis, 2: centrilobular and periportal fibrosis, 3: bridging fibrosis (few bridges), 4: bridging fibrosis (many bridges), 5: early or incomplete cirrhosis, 6: established or advanced cirrhosis.
Group
Value
95% CI
BMS-986036 10 mg
38.5
BMS-986036 20 mg
32.4
BMS-986036 40 mg
33.3
Placebo
35.9
The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48Secondary· From first dose to 48 weeks after first dose
The percentage of participants who achieved a ≥1-stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis at week 48 in liver biopsy. Improvement in fibrosis is defined by the NASH Clinical Research Network (CRN) Fibrosis Score. Improvement in NASH is defined by a ≥2-stage decrease in the nonalcoholic fatty liver disease activity score (NAS). NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
Group
Value
95% CI
BMS-986036 10 mg
33.3
BMS-986036 20 mg
40.5
BMS-986036 40 mg
35.9
Placebo
30.8
The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48Secondary· From first dose to 48 weeks after first dose
An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the non-alcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Score at week 48 in liver biopsy. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).
Group
Value
95% CI
BMS-986036 10 mg
35.9
BMS-986036 20 mg
29.7
BMS-986036 40 mg
28.2
Placebo
33.3
The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48Secondary· From first dose to 48 weeks after first dose
An improvement in CPA is defined as any decrease in CPA at week 48 in liver biopsy.
Group
Value
95% CI
BMS-986036 10 mg
61.8
BMS-986036 20 mg
54.2
BMS-986036 40 mg
41.9
Placebo
53.1
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48Secondary· From first dose to 48 weeks after first dose
NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 48 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade \<2).
Group
Value
95% CI
BMS-986036 10 mg
2.6
BMS-986036 20 mg
5.4
BMS-986036 40 mg
2.6
Placebo
0.0
The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48Secondary· From first dose to 48 weeks after first dose
The percentage of participants with NASH improvement at week 48 in liver biopsy. NASH improvement is defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥ 2 points with contribution from \> 1 NAS component. The NASH CRN system assesses liver biopsies for degree of steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2), and fibrosis (0-4). The 3 categories are added together in an unweighted fashion to determine the NAS, which ranges from 0 to 8.
Group
Value
95% CI
BMS-986036 10 mg
15.4
BMS-986036 20 mg
24.3
BMS-986036 40 mg
12.8
Placebo
2.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants were assessed for All-Cause Mortality from their randomization until the study was completed (up to approximately 39 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 52 weeks)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and liver cirrhosis (liver damage characterized by normal liver tissue being replaced by scar tissue).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04649710 — A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Partic
· Phase 1
· withdrawn
NCT04634149 — A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function a
· Phase 1
· completed
NCT04493567 — Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Admi
· Phase 1
· completed
NCT03674476 — An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney
· Phase 1
· completed
NCT03486899 — A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibro
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 13 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03486912.