At a glance
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Phase Ib Trial to Assess Safety and Tolerability of Multiple Subcutaneous Doses of BI 3006337 in Patients With Overweight or Obesity and Hepatic Steatosis
In Brief
A Phase 1 clinical trial evaluating BI 3006337 and Placebo matching BI 3006337 for Non-alcoholic Fatty Liver Disease and Obesity. Completed, enrolled 64 participants across 12 sites.
Detailed 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.
Study Details
Timeline
Interventions
Subject with overweight/obesity and steatosis received subcutaneous solution once weekly.
Subject with overweight/obesity and steatosis received subcutaneous solution once weekly.