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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 295 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04771273
The ClinicalTrials.gov registry entry for NCT04771273 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 295 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04771273 reports 0 study locations.
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.
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