NCT06352437

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 3034701	BI 3034701
DRUG	Placebo matching BI 3034701	Placebo matching BI 3034701

Timeline

• Start date: 2024-06-10
• Primary completion: 2025-10-07
• Completion: 2025-10-07
• First posted: 2024-04-08
• Last updated: 2025-11-21

Locations

1 site across 1 country: Germany