NCT06352437CompletedPhase 1
A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity
Safety, Tolerability and Pharmacokinetics of Single Subcutaneous Doses of BI 3034701 in Healthy Male Volunteers (Part A) and of Multiple Rising Subcutaneous Doses in Otherwise Healthy Male and Female Volunteers With Obesity/Overweight (Part B)
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy. The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood. Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time. Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 5 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 125 (actual)
- First submitted
- 3 Apr 2024
- Start date
- 10 Jun 2024
- Primary completion date
- 7 Oct 2025
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Obesity
- NCT number
- NCT06352437
- EU CT number
- 2023-508767-79-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 125
- From 10 Jun 2024 to the primary completion date, 7 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator.
Lab values
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and, in particular:
- Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%
- Aspartate aminotransferase (AST) above ULN + 20%
- Gamma-Glutamyl-Transferase (GGT) above ULN + 20%
- Lipase or amylase above ULN + 20%
- Bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome)
- Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m²
Other
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm).
- Further exclusion criteria apply.
Who the study is looking for
- Part A: healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- Part B: healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
- Part A: age of 18 to 55 years (inclusive). Part B: age 18 to 65 years (inclusive).
- Parts A and B: Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Further inclusion criteria apply
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.