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NCT05970640 · ClinicalTrials.gov registry record · Phase 1
A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
A Phase 1 study of Obesity and Non-alcoholic Fatty Liver Disease, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 12
- Study locations
NCT05970640: Completed Phase 1 study of Obesity and Non-alcoholic Fatty Liver Disease, sponsored by Boehringer Ingelheim.
NCT05970640 is a Phase 1 study of Obesity and Non-alcoholic Fatty Liver Disease that has completed, run by Boehringer Ingelheim. The registered enrollment target is 64 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 12 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05970640, a Phase 1 study of Obesity and Non-alcoholic Fatty Liver Disease, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study is open to adults with overweight or obesity who also have fatty liver disease. The purpose of this study is to find the highest dose of BI 3006337 that people with overweight or obesity and with fatty liver disease can tolerate. Participants are divided into 4 groups of equal size randomly, which means by chance. Different doses of BI 3006337 are given to participants in each group. Participants in each group receive an injection of either BI 3006337 or placebo once a week. Placebo injections look like BI 3006337 injections but do not contain any medicine. Participants are in the study for about 4 months. During this time, they visit the study site 18 times. Three of the visits include overnight stays at the study site. The doctors check the health of the participants and note any health problems that could have been caused by BI 3006337.
Primary Outcome
Number of subjects with drug-related adverse events (AEs) occurring between first administration of trial medication (BI 3006337 or placebo) and end of study (EOS) is reported.
Conditions Studied
Interventions
- DRUG BI 3006337
- DRUG Placebo matching BI 3006337
Study Locations (12)
California
- Velocity Clinical Research-Chula Vista - Chula Vista
- Velocity Clinical Research-La Mesa-69117 - La Mesa
- Catalina Research Institute, LLC-Montclair-49051 - Montclair
Texas
- The Liver Institute at Methodist Dallas - Dallas
- American Research Corporation at the Texas Liver Institute - San Antonio
- Endeavor Clinical Trials - San Antonio
Florida
- Accel Research Sites-Deland-67606 - DeLand
- Floridian Clinical Research-Miami Lakes-68368 - Miami Lakes
Georgia
- iResearch Atlanta - Decatur
Ohio
- Centricity Research-Columbus-68879 - Columbus
Tennessee
- AMR Knoxville - Knoxville
Utah
- Velocity Clinical Research-West Jordan-69043 - West Jordan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2023-08-14 |
| Est. Completion | 2024-11-07 |
| Phase | Phase 1 |
What the finished NCT05970640 record still lists
NCT05970640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which BI 3006337 is the first listed.
NCT05970640 lists 12 locations in 7 states (California, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT05970640 about?
NCT05970640 is a clinical study titled "A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease". This study is open to adults with overweight or obesity who also have fatty liver disease. The purpose of this study is to find the highest dose of BI 3006337 that people with overweight or obesity and with fatty liver disease can tolerate. Participants are divided into 4 groups of equal size rando...
What is the current status of trial NCT05970640?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2023-08-14. Estimated completion is 2024-11-07.
What conditions does trial NCT05970640 study?
This clinical trial studies the following conditions: Obesity, Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT05970640?
The interventions under investigation include: BI 3006337 (DRUG), Placebo matching BI 3006337 (DRUG).
Who is sponsoring clinical trial NCT05970640?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05970640 being conducted?
This trial has 12 study locations across California, Florida, Georgia, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05970640's enrollment target sits among peer trials
64 623rd of 1053 higher than 428 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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.
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