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NCT04771273 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 295
- Enrollment target
NCT04771273: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT04771273 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 295 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (122% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04771273, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 295 participants
- Enrollment target
Study Summary
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine. Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.
Primary Outcome
Percentage of patients who had an improvement from baseline in liver histological findings based on liver biopsy after 48 weeks of treatment is reported. Percentages were rounded to one decimal place. Improvement in histological findings was defined as a composite of improvement in NASH and no worsening of fibrosis. Improvement in non-alcoholic steatohepatitis (NASH) was defined as decrease of at least 2 points in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) with at least 1 p
Interventions
- DRUG Placebo
- DRUG Survodutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2023-12-21 |
| Phase | Phase 2 |
What the finished NCT04771273 record still lists
NCT04771273 is an interventional study that assigns participants to a tested intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (122% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04771273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04771273 about?
NCT04771273 is a clinical study titled "A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)". This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the...
What is the current status of trial NCT04771273?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 295 participants. The study started on 2021-04-27. Estimated completion is 2023-12-21.
What interventions are being tested in trial NCT04771273?
The interventions under investigation include: Placebo (DRUG), Survodutide (DRUG).
Who is sponsoring clinical trial NCT04771273?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04771273's enrollment target sits among peer trials
295 189th of 2000 higher than 1,811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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