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Clinical Trial ยท PHASE2 ยท Recruiting

A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight

07 September 2026 NCT07662122 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE2
Participants
ALL
Age Range
18 Years โ€“ 74 Years

About This Trial

This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg/m2 or more, or a BMI of 27 kg/m2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study.

The purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.

Participants are in the study for about 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.

Who Can Join?

Inclusion criteria: 1. Male or female, age โ‰ฅ18 to 18 years 2. Body mass index (BMI) โ‰ฅ30 kg/mยฒ at screening, OR BMI โ‰ฅ27 kg/mยฒ at screening with the presence of at least 1 weight-related complication. 3. History of at least one self-reported unsuccessful dietary effort to lose body weight 4. Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently 5. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the…

⚠ Always speak to your doctor before applying to any clinical trial.

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