A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4
Public ClinicalTrials.gov record NCT07052682. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07052682
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 11 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 17, 2023
- Primary completion
- Dec 29, 2024
- Completion
- Dec 29, 2024
- Last update posted
- Aug 18, 2025
2023 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 7
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Liver Health | Chandler | Arizona | 85224 | — |
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | — |
| Southern California Research Center | Coronado | California | 92118 | — |
| University of California, San Diego, NAFLD Research Center | La Jolla | California | 92037 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| Inland Empire Clinical Trials, LLC | Rialto | California | 92377 | — |
| Covenant Metabolic Specialist LLC | Fort Myers | Florida | 33912 | — |
| Covenant Metabolic Specialist LLC | Sarasota | Florida | 34240 | — |
| Tandem Clinical Research GI, LLC | Marrero | Louisiana | 70072 | — |
| Lucas Research, Inc | Morehead City | North Carolina | 28557 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Houston Research Institute | Houston | Texas | 77079 | — |
| Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Pinnacle Clinical Research LLC | San Antonio | Texas | 78229 | — |
| VCU Dept of Internal Medicine, Division of GI, Hepatology & Nutrition | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07052682, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 18, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07052682 live on ClinicalTrials.gov.