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NCT07662122PHASE2Recruiting

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

Boehringer Ingelheim

Start Date

6/30/2026

Completion Date

8/18/2027

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 Criteria

Age Range: 18 years to 74 years

Inclusion criteria: 1. Male or female, age ≥18 to \<75 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years 2. Body mass index (BMI) ≥30 kg/m² at screening, OR BMI ≥27 kg/m² 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 participant information sheet and in protocol. 6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Sign the informed consent form (ICF); Learn how to self-inject the investigational medicinal product (IMP)(s) in the abdomen as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP(s)) OR Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and physical activity plan), maintain diaries, complete required questionnaires, and handle the IMP(s) as described in the instructions for use (IFU) Exclusion criteria: 1. Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening 2. Treatment with anti-obesity medication and/or body weight change-inducing medication within 3 months before screening 3. Prior surgery of the gastrointestinal (GI) tract that could interfere with body weight including minimally invasive/endoscopic bariatric devices and any bariatric or metabolic surgery involving resection, sleeve gastrectomy, or bypass procedures (e.g. Roux-en-Y, one-anastomosis gastric bypass, duodenal-jejunal bypass sleeve), regardless of whether the device or bypass was removed. The following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening 4. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome) 5. A Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening 6. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose-lowering agent starting within 3 months before screening 7. Use of glucagon-like-peptide-1 receptor (GLP-1R), glucose-dependent insulinotropic polypeptide receptor (GIPR), glucagon receptor (GCGR) or neuropeptide Y receptor 2 (NPY2R) agonists (or the combinations thereof) within 3 months before screening 8. Answered "yes" to any of the suicide-related behaviours (actual attempt, interrupted attempt, aborted attempt, preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the "Suicidal Behaviour" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening visit up to and including the randomisation visit Further exclusion criteria apply.

Interventions

DRUG

BI 3034701

DRUG

Placebo matching BI 3034701

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Conditions

ObesityOverweight

Locations

Cahaba Research, Inc. - Trussville Location

Birmingham, Alabama 35235

United States

Focus Clinical Research

West Hills, California 91307

United States

CMR of Greater New Haven, LLC

Hamden, Connecticut 06517

United States

Optimus U Corporation-Miami-69452

Miami, Florida 33135

United States

Javara-Fayetteville-67354

Fayetteville, Georgia 30214

United States

Monroe Biomedical Research - Louisville

Louisville, Kentucky 40213

United States

Arcturus Healthcare - Troy Internal Medicine Research Division

Troy, Michigan 48098

United States

StudyMetrix Research, LLC

City of Saint Peters, Missouri 63303

United States

Clinvest Research LLC

Springfield, Missouri 65807

United States

Centricity Research - Morehead City

Morehead City, North Carolina 28557

United States

Accellacare-Wilmington-67123

Wilmington, North Carolina 28401

United States

Lillestol Research, LLC

Fargo, North Dakota 58104

United States

Tribe Clinical Research at Parkside OB-GYN, Greer

Greer, South Carolina 29650

United States

Texas Diabetes and Endocrinology

Austin, Texas 78731

United States

South Texas Research Institute - Brownsville

Brownsville, Texas 78520

United States

South Texas Research Institute-Edinburg-67012

Edinburg, Texas 78539

United States

IMA Clinical Research San Antonio

San Antonio, Texas 78229

United States

Data Point Clinical, LLC

Kirkland, Washington 98034

United States

Rainier Clinical Research Center

Renton, Washington 98057

United States

Allegiance Research Specialists

Wauwatosa, Wisconsin 53226

United States

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Logan Hospital

Meadowbrook, Queensland 4131

Australia

Southern Adelaide Diabetes and Endocrine Services

Oaklands Park, South Australia 5046

Australia

Monash University

Box Hill, Victoria 3128

Australia

Austin Health

Heidelberg, Victoria 3048

Australia

Coastal Digestive Health & CDH Research Institute

Queensland, 4558

Australia

Ocean West Research Clinic (Surrey)

Surrey, British Columbia V3Z 2N6

Canada

Hilltop Medical Clinic

Surrey, British Columbia V4A 0C1

Canada

Dr. M. B. Jones Inc.

Victoria, British Columbia V8V 4A1

Canada

Apex Trials (Guelph)

Guelph, Ontario N1G 0B4

Canada

Winterberry Research Inc.

Hamilton, Ontario L8J 0B6

Canada

The Wharton Medical Clinic Clinical Trials Inc.

Hamilton, Ontario L8L 5G8

Canada

Milestone Research Inc.

London, Ontario N5W 6A2

Canada

Stouffville Medical Research Institute Inc.

Stouffville, Ontario L4A 1H2

Canada

Canadian Phase Onward Inc.

Toronto, Ontario M3J 0K2

Canada

Ecogene-21

Chicoutimi, Quebec G7H 7K9

Canada

THEO Medical (Montreal)

Montreal, Quebec H3M 1L3

Canada

Centre Medical Acadie (9109-0126 Quebec Inc)

Montreal, Quebec H4N 2W2

Canada

Diex Recherche (Sherbrooke Est)

Sherbrooke, Quebec J1E 0N8

Canada

Diex Recherche (Victoriaville)

Victoriaville, Quebec G6P 3Z8

Canada

Diex Recherche (Quebec)

Québec, G1V 4T3

Canada

Huzhou Central Hospital

Huzhou, 313000

China

Center Hospital of Jinan

Jinan, 250013

China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, 471000

China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, 210011

China

The First Affiliated Hospital of Ningbo University

Ningbo, 315010

China

First Hospital of Qinhuangdao

Qinhuangdao, 066099

China

Tianjin Medical University Chu Hisen-I Memorial Hospital

Tianjin, 300070

China

Yichang Central People's Hospital

Yichang, 443008

China

Momentum Clinical Research Dunedin

Dunedin, Otago 9016

New Zealand

Waitemata Clinical Research

Auckland, 0626

New Zealand

Auckland City Hospital

Grafton / Auckland, 1023

New Zealand

Clinical Trials New Zealand Ltd

Hamilton, 3204

New Zealand

Momentum Clinical Research

Waikanae, 5036

New Zealand

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

Bucheon-si, 14647

South Korea

Eulji University Hospital

Daejeon, 35233

South Korea

Chosun university hospital

Gwangju, 61453

South Korea

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Fylde Coast Clinical Research

Blackpool, FY3 7EN

United Kingdom

The Garth Surgery

Guisborough, TS14 7DJ

United Kingdom

Velocity Clinical Research, High Wycombe

High Wycombe, HP11 2QW

United Kingdom

Leicester General Hospital

Leicester, LE5 4PW

United Kingdom

Linthorpe Surgery

Middlesbrough, TS5 6HA

United Kingdom

Banbury Cross Health Centre

Oxford, OX16 9AD

United Kingdom