NCT03486899 (FALCON 1) is a Phase 2 clinical trial of BMS-986036 in Liver Fibrosis, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT03486899?

NCT03486899 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT03486899?

Interventions in NCT03486899: BMS-986036, Placebo.

What condition does NCT03486899 study?

NCT03486899 studies Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis.

Is NCT03486899 still recruiting?

NCT03486899 is currently completed. Last updated 9 September 2022.

Are results published for NCT03486899?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-09-09 · How we verify

NCT03486899: FALCON 1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 9 September 2022

What this trial tests

Phase 2 trial testing BMS-986036 in Liver Fibrosis in 197 participants. Completed in 17 August 2021.

Timeline

19 June 2018

Primary endpoint
14 September 2020

17 August 2021

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	197
Start date	19 June 2018
Primary completion	14 September 2020
Estimated completion	17 August 2021
Sites	89 locations across Japan, United States

Drugs / interventions tested

BMS-986036 — full drug profile →
Placebo

Conditions studied

Liver Fibrosis — all drugs for Liver Fibrosis →
Nonalcoholic Fatty Liver Disease (NAFLD) — all drugs for Nonalcoholic Fatty Liver Disease (NAFLD) →
Nonalcoholic Steatohepatitis — all drugs for Nonalcoholic Steatohepatitis →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 75, any sex, with Liver Fibrosis or Nonalcoholic Fatty Liver Disease (NAFLD). 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 With Improvement in Fibrosis or Nonalcoholic Steatohepatitis (NASH) at Week 24 Primary · From first dose to 24 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 24 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). 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 deter

Group	Value	95% CI
BMS-986036 10 mg	30.6	0.88 – 8.52
BMS-986036 20 mg	24.0	0.61 – 6.27
BMS-986036 40 mg	26.5	0.71 – 7.10
Placebo	14.3	NA – NA

The Percentage of Participants Who Achieved an Improvement in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Score at Week 24 Secondary · From first dose to 24 weeks after first dose

An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the NASH CRN Fibrosis Score at week 24 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	16.3
BMS-986036 20 mg	14.0
BMS-986036 40 mg	20.4
Placebo	8.2

The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 24 Secondary · From first dose to 24 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 24 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	22.4
BMS-986036 20 mg	16.0
BMS-986036 40 mg	26.5
Placebo	12.2

The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 24 Secondary · From first dose to 24 weeks after first dose

An improvement in CPA is defined as any decrease in CPA at week 24 in liver biopsy.

Group	Value	95% CI
BMS-986036 10 mg	42.9
BMS-986036 20 mg	53.5
BMS-986036 40 mg	55.8
Placebo	65.9

The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis at Week 24 Secondary · From first dose to 24 weeks after first dose

The percentage of participants with NASH resolution without worsening of fibrosis at week 24 in liver biopsy. NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1. Worsening of fibrosis is defined as an increase of fibrosis by ≥ 1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade \<2). NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridg

Group	Value	95% CI
BMS-986036 10 mg	8.2
BMS-986036 20 mg	4.0
BMS-986036 40 mg	2.0
Placebo	6.1

The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 24 Secondary · From first dose to 24 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 24 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade \<2).

Group	Value	95% CI
BMS-986036 10 mg	8.2
BMS-986036 20 mg	4.0
BMS-986036 40 mg	2.0
Placebo	6.1

The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement Without Worsening of Fibrosis at Week 24 Secondary · From first dose to 24 weeks after first dose

The percentage of participants with NASH improvement without worsening of fibrosis at week 24 in liver biopsy. NASH improvement defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥2 points with contribution from \>1 NAS component. Worsening of fibrosis is defined as an increase of ≥1-point in the NASH Clinical Research Network (CRN) Fibrosis Score. 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	22.4
BMS-986036 20 mg	14.0
BMS-986036 40 mg	16.3
Placebo	10.2

The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 24 Secondary · From first dose to 24 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 24 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. 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	16.3
BMS-986036 20 mg	14.0
BMS-986036 40 mg	16.3
Placebo	8.2

The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 24 Secondary · From first dose to 24 weeks after first dose

The percentage of participants with NASH improvement at week 24 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	24.5
BMS-986036 20 mg	18.0
BMS-986036 40 mg	16.3
Placebo	10.2

The Percentage of Participants With Progression to Cirrhosis at Week 24 Secondary · From first dose to 24 weeks after first dose

Progression to cirrhosis is defined by the nonalcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Stage 4 at Week 24 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	30.6
BMS-986036 20 mg	22.0
BMS-986036 40 mg	28.6
Placebo	20.4

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality was assessed from first dose to study completion (up to approximately 35 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.

BMS-986036 10 mg

Serious: 3/49 (6%)

Deaths: 1/49

BMS-986036 20 mg

Serious: 7/50 (14%)

Deaths: 0/50

BMS-986036 40 mg

Serious: 6/49 (12%)

Deaths: 0/49

BMS-986036 Placebo

Serious: 9/49 (18%)

Deaths: 1/49

Serious adverse events (29 terms)

Reaction	System	BMS-986036 10 mg	BMS-986036 20 mg	BMS-986036 40 mg	BMS-986036 Placebo
Non-cardiac chest pain	General disorders	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—
Coronary artery occlusion	Cardiac disorders	—	—	—	—
Vertigo positional	Ear and labyrinth disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—
Epiploic appendagitis	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—	—
Campylobacter infection	Infections and infestations	—	—	—	—
Post procedural infection	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—
Splenic rupture	Injury, poisoning and procedural complications	—	—	—	—
Liver function test increased	Investigations	—	—	—	—
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	—	—	—	—
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—

Other adverse events (40 terms — click to expand)

Reaction	System	BMS-986036 10 mg	BMS-986036 20 mg	BMS-986036 40 mg	BMS-986036 Placebo
Nausea	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Injection site erythema	General disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Injection site bruising	General disorders	—	—	—	—
Injection site pain	General disorders	—	—	—	—
Increased appetite	Metabolism and nutrition disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Injection site pruritus	General disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—
Type 2 diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Frequent bowel movements	Gastrointestinal disorders	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—
Vulvovaginal mycotic infection	Infections and infestations	—	—	—	—
Flank pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—

Most-reported serious reactions: Non-cardiac chest pain, Coronary artery disease, Coronary artery occlusion, Vertigo positional, Abdominal pain upper, Colitis, Epiploic appendagitis, Vomiting.

Data from ClinicalTrials.gov NCT03486899 adverse events section.

Sponsor's own description

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 stage 3 liver fibrosis (severe fibrosis).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Polymer-drug conjugate therapeutics: advances, insights and prospects.
Ekladious I, Colson YL, Grinstaff MW. · · 2019 · cited 493× · PMID 30542076 · DOI 10.1038/s41573-018-0005-0
Emerging therapeutic approaches for the treatment of NAFLD and type 2 diabetes mellitus.
Ferguson D, Finck BN. · · 2021 · cited 370× · PMID 34131333 · DOI 10.1038/s41574-021-00507-z
NAFLD: Mechanisms, Treatments, and Biomarkers.
Nassir F. · · 2022 · cited 245× · PMID 35740949 · DOI 10.3390/biom12060824
Targeted therapeutics and novel signaling pathways in non-alcohol-associated fatty liver/steatohepatitis (NAFL/NASH).
Xu X, Poulsen KL, Wu L, Liu S, et al · · 2022 · cited 235× · PMID 35963848 · DOI 10.1038/s41392-022-01119-3
Combination therapy for non-alcoholic steatohepatitis: rationale, opportunities and challenges.
Dufour JF, Caussy C, Loomba R. · · 2020 · cited 145× · PMID 32381514 · DOI 10.1136/gutjnl-2019-319104
New targets for NAFLD.
Parlati L, Régnier M, Guillou H, Postic C. · · 2021 · cited 128× · PMID 34667947 · DOI 10.1016/j.jhepr.2021.100346
Therapeutic targets, novel drugs, and delivery systems for diabetes associated NAFLD and liver fibrosis.
Kumar V, Xin X, Ma J, Tan C, et al · · 2021 · cited 128× · PMID 34314787 · DOI 10.1016/j.addr.2021.113888
Nonalcoholic Fatty Liver Disease (NAFLD). Mitochondria as Players and Targets of Therapies?
Di Ciaula A, Passarella S, Shanmugam H, Noviello M, et al · · 2021 · cited 93× · PMID 34065331 · DOI 10.3390/ijms22105375

Verify or expand the search:

Other trials of BMS-986036

Trials testing the same drug.

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
NCT03486912 — A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis · Phase 2 · completed

Other recruiting trials for Liver Fibrosis

Currently open trials in the same condition.

NCT07031089 — City-Hospital Collaboration for Early Detection of Liver Fibrosis in Primary Care: A Secondary Prevention Project in the · recruiting
NCT06940375 — Incidence of Liver Disease-Related Outcomes in People With HIV · recruiting
NCT07271576 — Research on the Protective Effects of Phycocyanin Against Liver Fibrosis and Cirrhosis · NA · recruiting
NCT07069725 — The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Partic · Phase 1 · recruiting
NCT07122700 — Evaluation of Non-Invasive Tests for Metabolic Liver Disease · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03486899 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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: 9 September 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/NCT03486899.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing