Loading clinical trials...

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

COMPLETEDPHASE1

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

NCT05970640•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\- Male or female trial participants ≥18 years and ≤75 years of age at time of consent.
•Women of child-bearing potential (WOCBP) must be willing and able to use 2 forms of effective contraception where at least 1 form is a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly. Male trial participants must be willing and able to use condom if their partner is a WOCBP
•Body mass index (BMI) ≥25 - \<40 kg/m\^2
•Liver fat fraction ≥8% as measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF)
•Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria

•\- Current or past significant alcohol consumption (daily alcohol consumption in women should not exceed more than one standard drink per day and two drinks per day for men, whereby one standard drink is equivalent to 12 oz beer \[5% alcohol\]; 5 ounces of wine \[12% alcohol\], 1.5 ounces of 80 proof \[40% alcohol\]) or inability to reliably quantify alcohol consumption based on Investigator judgement within the last 5 years.
•The Alcohol Use Disorders Identification Test (AUDIT) shall be used a standardized screening tool for alcohol use disorder
•Intake of medications historically associated with liver injury, hepatic steatosis, or steatohepatitis (e.g. oral or intravenous corticosteroids, methotrexate, valproic acid, tamoxifen, tetracycline, amiodarone) for more than 14 consecutive days within 12 weeks prior to the screening visit
•Presence of any form of acute or chronic liver disease other than simple steatosis (e.g. viral hepatitis, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency). Chronic viral hepatitis parameters that would be considered exclusionary for the participation to this trial are (hepatitis B and C testing will be done at the screening visit):
•* Hepatitis B virus (HBV): trial participants with positive Hepatitis B virus surface antigen (HbsAg)
•* Hepatitis C virus (HCV): trial participants with positive HCV RNA. Trial participants treated for hepatitis C must have a negative RNA test at screening and also be HCV RNA negative for at least 3 years prior to screening in order to be eligible for the trial
•Liver stiffness \>10 Kilopascal (kPa) as measured using Fibroscan. In patients with a non-valid Fibroscan measurement, a Fib-4 score \>1.3 should be considered exclusionary.
•Suspicion, confirmed diagnosis, or history of hepatocellular carcinoma
•Treatment with vitamin E (at a minimum dose of 800 IU/day) or pioglitazone not stable (in the opinion of the Investigator) within 90 days before screening
•History of type 1 diabetes

Locations (12)

Velocity Clinical Research-Chula Vista

Chula Vista, California, United States

Velocity Clinical Research-La Mesa-69117

La Mesa, California, United States

Catalina Research Institute, LLC-Montclair-49051

Montclair, California, United States

Accel Research Sites-Deland-67606

DeLand, Florida, United States

Floridian Clinical Research-Miami Lakes-68368

Miami Lakes, Florida, United States

iResearch Atlanta

Decatur, Georgia, United States

Centricity Research-Columbus-68879

Columbus, Ohio, United States

AMR Knoxville

Knoxville, Tennessee, United States

The Liver Institute at Methodist Dallas

Dallas, Texas, United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

Key Dates

Start Date

August 14, 2023

Primary Completion Date

October 31, 2024

Completion Date

November 7, 2024

Last Updated

December 5, 2025

Enrollment

ACTUAL participants

Conditions

Non-alcoholic Fatty Liver DiseaseObesity

Interventions

BI 3006337

DRUG

Placebo matching BI 3006337

DRUG

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

View study

RECRUITINGNA

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial

Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose

Protein Supplementation Intervention on Body Weight

iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss