RecruitingPhase 2NCT07662122

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

A Phase II, Randomised, Double-blind, Parallel-group, 42-week Dose-finding Trial for BI 3034701 Administered Subcutaneously Compared to Placebo in Participants With Obesity or Overweight


Sponsor

Boehringer Ingelheim

Enrollment

300 participants

Start Date

Jun 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BI 3034701 and a drug called Placebo matching BI 3034701 for people with obesity and overweight. The study is currently recruiting participants at 63 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBI 3034701

BI 3034701

DRUGPlacebo matching BI 3034701

Placebo matching BI 3034701


Locations(66)

Cahaba Research, Inc. - Trussville Location

Birmingham, Alabama, United States

Focus Clinical Research

West Hills, California, United States

CMR of Greater New Haven, LLC

Hamden, Connecticut, United States

Optimus U Corporation-Miami-69452

Miami, Florida, United States

Javara-Fayetteville-67354

Fayetteville, Georgia, United States

Monroe Biomedical Research - Louisville

Louisville, Kentucky, United States

Arcturus Healthcare - Troy Internal Medicine Research Division

Troy, Michigan, United States

StudyMetrix Research, LLC

City of Saint Peters, Missouri, United States

Clinvest Research LLC

Springfield, Missouri, United States

Centricity Research - Morehead City

Morehead City, North Carolina, United States

Accellacare-Wilmington-67123

Wilmington, North Carolina, United States

Lillestol Research, LLC

Fargo, North Dakota, United States

Tribe Clinical Research at Parkside OB-GYN, Greer

Greer, South Carolina, United States

Texas Diabetes and Endocrinology

Austin, Texas, United States

South Texas Research Institute - Brownsville

Brownsville, Texas, United States

South Texas Research Institute-Edinburg-67012

Edinburg, Texas, United States

IMA Clinical Research San Antonio

San Antonio, Texas, United States

Data Point Clinical, LLC

Kirkland, Washington, United States

Rainier Clinical Research Center

Renton, Washington, United States

Allegiance Research Specialists

Wauwatosa, Wisconsin, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Logan Hospital

Meadowbrook, Queensland, Australia

Southern Adelaide Diabetes and Endocrine Services

Oaklands Park, South Australia, Australia

Monash University

Box Hill, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Coastal Digestive Health & CDH Research Institute

Queensland, Australia

Ocean West Research Clinic (Surrey)

Surrey, British Columbia, Canada

Hilltop Medical Clinic

Surrey, British Columbia, Canada

Dr. M. B. Jones Inc.

Victoria, British Columbia, Canada

Apex Trials (Guelph)

Guelph, Ontario, Canada

Winterberry Research Inc.

Hamilton, Ontario, Canada

The Wharton Medical Clinic Clinical Trials Inc.

Hamilton, Ontario, Canada

Milestone Research Inc.

London, Ontario, Canada

Stouffville Medical Research Institute Inc.

Stouffville, Ontario, Canada

Canadian Phase Onward Inc.

Toronto, Ontario, Canada

Ecogene-21

Chicoutimi, Quebec, Canada

THEO Medical (Montreal)

Montreal, Quebec, Canada

Centre Medical Acadie (9109-0126 Quebec Inc)

Montreal, Quebec, Canada

Diex Recherche (Sherbrooke Est)

Sherbrooke, Quebec, Canada

Diex Recherche (Victoriaville)

Victoriaville, Quebec, Canada

Diex Recherche (Quebec)

Québec, Canada

Huzhou Central Hospital

Huzhou, China

Center Hospital of Jinan

Jinan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

First Hospital of Qinhuangdao

Qinhuangdao, China

Tianjin Medical University Chu Hisen-I Memorial Hospital

Tianjin, China

Yichang Central People's Hospital

Yichang, China

Momentum Clinical Research Dunedin

Dunedin, Otago, New Zealand

Waitemata Clinical Research

Auckland, New Zealand

Auckland City Hospital

Grafton / Auckland, New Zealand

Clinical Trials New Zealand Ltd

Hamilton, New Zealand

Momentum Clinical Research

Waikanae, New Zealand

The Catholic University of Korea, Bucheon St.Mary's Hospital

Bucheon-si, South Korea

Eulji University Hospital

Daejeon, South Korea

Chosun university hospital

Gwangju, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Korea University Anam Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Fylde Coast Clinical Research

Blackpool, United Kingdom

The Garth Surgery

Guisborough, United Kingdom

Velocity Clinical Research, High Wycombe

High Wycombe, United Kingdom

Leicester General Hospital

Leicester, United Kingdom

Linthorpe Surgery

Middlesbrough, United Kingdom

Banbury Cross Health Centre

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07662122


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