Phase 1
N=63
A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
Non-alcoholic Fatty Liver Disease · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05970640 ↗Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Dec 2025
Primary outcome: Primary: Number of Subjects With Drug-related Adverse Events (AEs) — 9; 8; 14; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 3006337 (Drug); Placebo matching BI 3006337 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Drug-related Adverse Events (AEs) |
9; 8; 14; 5 | — |
| SECONDARY 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 |
21000; 38800; 67100 | — |
| SECONDARY Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Cmax,ss) After the Last Dose in Week 12 |
312; 761; 1060 | — |
| SECONDARY 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 |
13; 15; 27 | — |
| SECONDARY Relative Percentage Change in Liver Steatosis From Baseline After 12 Weeks of Treatment |
-13.01; -16.59; -39.21; 6.13 | — |
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 Criteria
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 - 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.
Data sourced from ClinicalTrials.gov (NCT05970640). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.