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TERMINATEDPHASE1

A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4

A Multicenter, Single-arm, Open-label, Phase 1b Study to Explore the Mechanism of Action and Evaluate the Safety of Ontamalimab in Participants With Nonalcoholic Steatohepatitis With Fibrosis Stage 1 Through 4

NCT07052682•Takeda

View on ClinicalTrials.gov

Summary

The main aim of this study is to evaluate the safety and tolerability of ontamalimab in participants with a liver disease called nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) with scarring in the liver (fibrosis stage 1 to 4). The study will also check if there are any important changes in the body's health markers (biomarkers) from the beginning of the study to see if ontamalimab stops liver scarring and reduces inflammation of the liver. Participants will be in the study for approximately up to 46 weeks.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The participant is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator.
•2. The participant and/or the participant's legally acceptable representative has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\] or electronic consent \[eConsent\] if applicable) and any required privacy authorization prior to the initiation of any study procedures.
•3. The participant is aged 18 to 70 years, inclusive, at the time of signing the ICF.
•4. The participant has signs of fibrogenic activity (Pro-C3 greater than or equal to \[\>=\] 12.6 nanograms per milliliter \[ng/mL\], ELF score \>=7.7) at the Week -8 (screening visit 1 \[SV1\]) (applies to all participants regardless of whether historical biopsy results are available at screening).
•5. The participant has indication of NASH via biopsy (Nonalcoholic fatty liver disease activity score \[NAS\] \>=3 with at least 1 point in lobular inflammation) and liver fibrosis stage 1 (F1) through fibrosis stage 4 compensated cirrhotic (F4cc) according to NASH Clinical Research Network (CRN).
•6. The participant is a male participant or a nonpregnant, nonlactating female participant who, if sexually active, agrees to comply with the contraceptive requirements of the protocol, or a female participant of nonchildbearing potential. Participants of reproductive potential who are sexually active must agree to use appropriate contraception (that is, highly effective methods for female participants and medically appropriate methods for male participants) for the duration of the study and for at least 12 weeks after the last dose of study drug.
•7. The participant, if capable of breastfeeding, agrees to forego breastfeeding for the period from informed consent until 12 weeks after the last dose of study drug.
•5. The participant has a history of impaired hemostasis that, in the investigator's judgement, would increase the risk to the participant if he or she participates in the study.
•6. The participant has a significant concurrent medical condition at the time of screening or baseline, including, but not limited to, the following:
•1. Any major illness/condition or evidence of an unstable clinical condition (example, hepatic, renal, hematologic, gastrointestinal, endocrine \[example, uncontrolled diabetes or type 1 diabetes mellitus, or thyroid disease\], neurological \[pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening\], cardiovascular, pulmonary, immunologic \[example, Felty's syndrome\], or local active infection/infectious illness \[any bacterial, fungal, or viral, example, clinically active cytomegalovirus, Epstein-Barr virus, herpes simplex virus\]) that, in the investigator's judgment will substantially increase the risk to the participant if he or she participates in the study.
+31 more criteria

Exclusion Criteria

•1. The following laboratory findings are exclusionary for all participants if found during screening visits (Week -8 \[SV1\], Week -6 \[SV2\] or at Day -4 visit \[Visit 4a2\]):
•1. Aspartate aminotransferase (AST) levels greater than (\>) 5\*the upper limit of normal (ULN).
•2. Alanine aminotransferase (ALT) levels \>5\*ULN.
•2. The following laboratory findings are exclusionary for all participants if found during either screening visit (SV1 or SV2):
•1. Alkaline phosphatase (ALP) \>=2\*ULN.
•2. Serum creatinine \>=1.5\*ULN or has an estimated glomerular filtration rate (eGFR) less than (\<) 45 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
•3. International normalized ratio (INR) \>=1.3 (except for participants who are receiving anticoagulant treatment).
•4. Total bilirubin level (TBL) \>=ULN (except for participants with a documented history of Gilbert's syndrome if direct bilirubin is within normal reference range).
•5. Direct bilirubin \>=3\*ULN.
•6. Platelet count \<60\*10\^9 per liter (/L).
+4 more criteria

Locations (15)

Arizona Liver Health

Chandler, Arizona, United States

Adobe Clinical Research, LLC

Tucson, Arizona, United States

Southern California Research Center

Coronado, California, United States

University of California, San Diego, NAFLD Research Center

La Jolla, California, United States

California Liver Research Institute

Pasadena, California, United States

Inland Empire Clinical Trials, LLC

Rialto, California, United States

Covenant Metabolic Specialist LLC

Fort Myers, Florida, United States

Covenant Metabolic Specialist LLC

Sarasota, Florida, United States

Tandem Clinical Research GI, LLC

Marrero, Louisiana, United States

Lucas Research, Inc

Morehead City, North Carolina, United States

Key Dates

Start Date

January 18, 2023

Primary Completion Date

December 30, 2024

Completion Date

December 30, 2024

Last Updated

August 19, 2025

Enrollment

ACTUAL participants

Conditions

Steatohepatitis

Interventions

Ontamalimab

DRUG

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

NCT06632444

Metabolic Dysfunction Associated Steatohepatitis (MASH)Liver Fibrosis

View study

RECRUITING

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

NCT02815891

Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4

Inclusion Criteria

Exclusion Criteria

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Identification of Liver Fibrosis Biomarkers

Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

Using Hydroxychloroquine (HCQ) to Treat Steatohepatitis

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients