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Completed

NCT Number: 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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velocity Clinical Research-Chula Vista, Chula Vista, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Use of Glucagon-like peptide 1 (GLP1)-receptor agonists within last 90 days before screening Further exclusion criteria apply.

Treatment and study plan

BI 3006337

Drug

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

Placebo matching BI 3006337

Drug

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

Primary outcomes

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

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

    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.

Secondary outcomes

  1. 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

    Time frame: 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

    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 is reported.

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

    Time frame: 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

    Maximum measured concentration of BI 3006337 in serum at steady state (Cmax,ss) after the last dose in Week 12 is reported.

  3. 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

    Time frame: 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 is reported.

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

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

    Relative percentage change in liver steatosis from baseline after 12 weeks of treatment is reported. Liver steatosis is measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2023
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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