A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Public ClinicalTrials.gov record NCT04771273. 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
Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04771273
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 295 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 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
- Apr 27, 2021 (Actual)
- Primary completion
- Nov 9, 2023 (Actual)
- Completion
- Dec 21, 2023 (Actual)
- Last update posted
- Dec 3, 2024
2021 – 2023
United States locations
- U.S. sites
- 36
- U.S. states
- 16
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Alabama Health Research, LLC | Huntsville | Alabama | 35801 | — |
| Southern California Research Center | Coronado | California | 92118 | — |
| Velocity Clinical Research | Huntington Park | California | 90255 | — |
| Velocity Clinical Research | Panorama City | California | 91402 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Integrity Clinical Research, LLC | Doral | Florida | 33166 | — |
| Covenant Metabolic Specialists, LLC | Fort Myers | Florida | 33912 | — |
| Optimus U Corporation | Miami | Florida | 33135 | — |
| Sanchez Clinical Research ,Inc | Miami | Florida | 33157 | — |
| Ocala GI Research | Ocala | Florida | 34471 | — |
| Omega Research Orlando, LLC | Orlando | Florida | 32808 | — |
| Covenant Metabolic Specialists, LLC | Sarasota | Florida | 34240 | — |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | — |
| Digestive Research Alliance of Michiana | South Bend | Indiana | 46635 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Delta Research Partners, LLC | Bastrop | Louisiana | 71220 | — |
| Centex Studies, Inc. | Lake Charles | Louisiana | 70601 | — |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | — |
| NECCR PrimaCare Research, LLC | Fall River | Massachusetts | 02721 | — |
| National Diabetes and Obesity Research Institute | Biloxi | Mississippi | 39532 | — |
| Gastrointestinal Associates | Flowood | Mississippi | 39232 | — |
| AIG Digestive Disease Research | Florham Park | New Jersey | 07932 | — |
| Northeast GI Research Division | Concord | North Carolina | 28027 | — |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | — |
| Digestive Diseases Research Center | Greenwood | South Carolina | 29646 | — |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | — |
| Digestive Health Research, LLC | Hermitage | Tennessee | 37076 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Texas Liver Institute | Austin | Texas | 78757 | — |
| South Texas Research Institute | Brownsville | Texas | 78520 | — |
| South Texas Research Institute | Edinburg | Texas | 78539 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth University | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 118 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04771273, 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 Dec 3, 2024 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04771273 live on ClinicalTrials.gov.