NCT05970640

A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease

Phase Ib Trial to Assess Safety and Tolerability of Multiple Subcutaneous Doses of BI 3006337 in Patients With Overweight or Obesity and Hepatic Steatosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-alcoholic Fatty Liver Disease
• Obesity

Interventions

Type	Name	Description
DRUG	BI 3006337	Subject with overweight/obesity and steatosis received subcutaneous solution once weekly.
DRUG	Placebo matching BI 3006337	Subject with overweight/obesity and steatosis received subcutaneous solution once weekly.

Timeline

• Start date: 2023-08-14
• Primary completion: 2024-10-31
• Completion: 2024-11-07
• First posted: 2023-08-01
• Last updated: 2025-12-05
• Results posted: 2025-12-05

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study