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NCT07052682 · ClinicalTrials.gov registry record · Phase 1

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 Phase 1 study, sponsored by Takeda.

Terminated
Registry status
Phase 1
Development phase
11
Enrollment target

NCT07052682: Clinical Trial Phase 1 study, sponsored by Takeda.

NCT07052682 is a Phase 1 study that was terminated before completion, run by Takeda. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07052682, a Phase 1 study, was terminated before completion, sponsored by Takeda.

TERMINATED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAEs was defined as any event that emerged or manifested at or after the initiation of treatment with a study drug or medicinal product, or any existing event that worsened in either intensity or frequency following exposure to the study drug or medicinal product.

Interventions

  • DRUG Ontamalimab

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2023-01-18
Est. Completion 2024-12-30
Phase Phase 1
Takeda

408 total trials

Why NCT07052682 stopped before completion

NCT07052682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 1 intervention - of which Ontamalimab is the first listed.

NCT07052682 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07052682 about?

NCT07052682 is a clinical study titled "A Study to Evaluate How Ontamalimab Works and Assess Its Safety and Tolerability in People With Nonalcoholic Steatohepatitis With Fibrosis Stages 1 to 4". 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 chec...

What is the current status of trial NCT07052682?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2023-01-18. Estimated completion is 2024-12-30.

What interventions are being tested in trial NCT07052682?

The interventions under investigation include: Ontamalimab (DRUG).

Who is sponsoring clinical trial NCT07052682?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07052682's enrollment target sits among peer trials

11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07052682, the US trial registry maintained by the National Library of Medicine. NCT07052682 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.