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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

  • NCT05970640
  • PHASE1
  • INTERVENTIONAL

Last updated: 2024-08-21

Purpose of  Trial

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.


This study is for people with

Non-alcoholic Fatty Liver Disease

Obesity


Interventions being studied

BI 3006337

Placebo matching BI 3006337

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ELIGIBILITY

Gender: ALL

Age: 18+

Healthy Volunteers: No

14 Locations
Chula Vista

Velocity Clinical Research


California, 91911, United States
La Mesa

Velocity Clinical Research


California, 91942, United States
Montclair

Catalina Research Institute, LLC


California, 91763, United States
DeLand

Accel Research Sites


Florida, 32720, United States
Hollywood

Research Centers of America


Florida, 33024, United States
Miami Lakes

Floridian Clinical Research


Florida, 33016, United States
Miami

Clinical Pharmacology of Miami


Florida, 33014, United States
Decatur

iResearch Atlanta


Georgia, 30030, United States
Columbus

Centricity Research


Ohio, 43213, United States
Knoxville

AMR Knoxville


Tennessee, 37920, United States
Dallas

The Liver Institute at Methodist Dallas


Texas, 75203, United States
San Antonio

American Research Corporation at the Texas Liver Institute


Texas, 78215, United States
San Antonio

Endeavor Clinical Trials


Texas, 78240, United States
West Jordan

Velocity Clinical Research


Utah, 84088, United States
Primary Contact(s)

Boehringer Ingelheim

Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at ClinicalTrials.gov

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