A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
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ClinicalTrials.gov Identifier: NCT04771273 |
Recruitment Status :
Completed
First Posted : February 25, 2021
Last Update Posted : April 30, 2024
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | February 24, 2021 | ||||||||||||||||
First Posted Date ICMJE | February 25, 2021 | ||||||||||||||||
Last Update Posted Date | April 30, 2024 | ||||||||||||||||
Actual Study Start Date ICMJE | April 27, 2021 | ||||||||||||||||
Actual Primary Completion Date | November 9, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Percentage of patients with histological improvement of NASH (NAS reduction of 2 or more points) after 48 weeks of treatment [ Time Frame: Week 48 ] Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) represents the sum of scores for steatosis (0-3), lobular inflammation (0-3) and ballooning (0-2); the total score ranges from 0 to 8.
Improvement in histological findings is defined as a composite of:
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3) | ||||||||||||||||
Official Title ICMJE | 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 | 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. |
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Detailed Description | Not Provided | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Non-alcoholic Steatohepatitis (NASH) | ||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||
Actual Enrollment ICMJE |
295 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
240 | ||||||||||||||||
Actual Study Completion Date ICMJE | December 21, 2023 | ||||||||||||||||
Actual Primary Completion Date | November 9, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Further inclusion criteria apply. Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, New Zealand, Poland, Portugal, Singapore, Spain, Taiwan, United Kingdom, United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04771273 | ||||||||||||||||
Other Study ID Numbers ICMJE | 1404-0043 2020-002723-11 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Boehringer Ingelheim | ||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||
Current Study Sponsor ICMJE | Boehringer Ingelheim | ||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE | Not Provided | ||||||||||||||||
PRS Account | Boehringer Ingelheim | ||||||||||||||||
Verification Date | April 2024 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |