NCT07052682

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Steatohepatitis

Interventions

Type	Name	Description
DRUG	Ontamalimab	Ontamalimab SC injection.

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2025-07-06
• Last updated: 2025-08-19
• Results posted: 2025-08-19

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study