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

Conditions

• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• BI 3034701 — DRUG
  BI 3034701
• Placebo matching BI 3034701 — DRUG
  Placebo matching BI 3034701

Study Details

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.

Key Dates

First listed

Jun 23, 2026

Start date

Jun 30, 2026

Status verified

Sep 2026

Primary completion

Aug 4, 2027

Completion

Aug 18, 2027

Study Design

Enrollment

342 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BI 3034701 treatment group 1
• Experimental: BI 3034701 treatment group 2
• Experimental: BI 3034701 treatment group 3
• Experimental: BI 3034701 treatment group 4
• Experimental: BI 3034701 treatment group 5
• Experimental: BI 3034701 treatment group 6
• Placebo Comparator: Placebo

Primary Outcome Measure

Percentage change in body weight from baseline at Week 42 [%] [ Time Frame: Baseline and at Week 42. ]

Locations (19)

Find similar trials in Birmingham, AL

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