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

NCT05970640 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 1466-0002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 12

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Drug-related Adverse Events (AEs)

  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.

  From drug administration of BI 3006337 until end of the treatment, up to 99 days

Secondary Outcomes (4)

• Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Dosing Interval Tau at Steady State (AUCτ,ss) After the Last Dose in Week 12

  0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 and 504 hours after drug administration in week 12

• Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Cmax,ss) After the Last Dose in Week 12

  0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 hours after drug administration in week 12

• Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Tmax,ss) After the Last Dose in Week 12

  0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 hours after drug administration in week 12

• Relative Percentage Change in Liver Steatosis From Baseline After 12 Weeks of Treatment

  Baseline (-48 to -4): the last observed measurement prior to drug administration, Day 85

Study Arms (4)

BI 3006337 50 mg

EXPERIMENTAL

Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.

Drug: BI 3006337

BI 3006337 100 mg

EXPERIMENTAL

Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.

Drug: BI 3006337

BI 3006337 150 mg

EXPERIMENTAL

Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.

Drug: BI 3006337

Placebo

PLACEBO COMPARATOR

Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.

Drug: Placebo matching BI 3006337

Interventions

BI 3006337 DRUG

Subject with overweight/obesity and steatosis received subcutaneous solution once weekly.

BI 3006337 100 mg; BI 3006337 150 mg; BI 3006337 50 mg

Placebo matching BI 3006337 DRUG

Subject with overweight/obesity and steatosis received subcutaneous solution once weekly.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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
• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (12)

Velocity Clinical Research-Chula Vista

Chula Vista, California, 91911, United States

Location

Velocity Clinical Research-La Mesa-69117

La Mesa, California, 91942, United States

Location

Catalina Research Institute, LLC-Montclair-49051

Montclair, California, 91763, United States

Location

Accel Research Sites-Deland-67606

DeLand, Florida, 32720, United States

Location

Floridian Clinical Research-Miami Lakes-68368

Miami Lakes, Florida, 33016, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

Centricity Research-Columbus-68879

Columbus, Ohio, 43213, United States

Location

AMR Knoxville

Knoxville, Tennessee, 37920, United States

Location

The Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Velocity Clinical Research-West Jordan-69043

West Jordan, Utah, 84088, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: August 14, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 7, 2024
• Last Updated: December 5, 2025
• Results First Posted: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)