Clinical trial

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

Recruiting now · Phase 2 · 6 countries · Registry ID NCT07662122

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 74 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight

Full registry criteria

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.

Treatments and study arms

BI 3034701

Drug

BI 3034701

Placebo matching BI 3034701

Drug

Placebo matching BI 3034701

Primary outcomes

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

Study locations

54 locations were listed when this page was built. The first 40 are shown.

Eastern Health-Box Hill Hospital🇦🇺 Box Hill, Victoria, Australia
Boehringer IngelheimContact
Southern Adelaide Diabetes and Endocrine Services (SADES)🇦🇺 Oaklands Park, South Australia, Australia
Boehringer IngelheimContact
Coastal Digestive Health & CDH Research Institute🇦🇺 Queensland, Australia
Boehringer IngelheimContact
Ecogene-21🇨🇦 Chicoutimi, Quebec, Canada
Boehringer IngelheimContact
Apex Trials (Guelph)🇨🇦 Guelph, Ontario, Canada
Boehringer IngelheimContact
The Wharton Medical Clinic Clinical Trials Inc.🇨🇦 Hamilton, Ontario, Canada
Boehringer IngelheimContact
Winterberry Research Inc.🇨🇦 Hamilton, Ontario, Canada
Boehringer IngelheimContact
Milestone Research Inc.🇨🇦 London, Ontario, Canada
Boehringer IngelheimContact
Centre Medical Acadie (9109-0126 Quebec Inc)🇨🇦 Montreal, Quebec, Canada
Boehringer IngelheimContact
THEO Medical (Montreal)🇨🇦 Montreal, Quebec, Canada
Boehringer IngelheimContact
Diex Recherche (Quebec)🇨🇦 Québec, Canada
Boehringer IngelheimContact
Diex Recherche (Sherbrooke Est)🇨🇦 Sherbrooke, Quebec, Canada
Boehringer IngelheimContact
Stouffville Medical Research Institute Inc.🇨🇦 Stouffville, Ontario, Canada
Boehringer IngelheimContact
Hilltop Medical Clinic🇨🇦 Surrey, British Columbia, Canada
Boehringer IngelheimContact
Ocean West Research Clinic (Surrey)🇨🇦 Surrey, British Columbia, Canada
Boehringer IngelheimContact
Canadian Phase Onward Inc.🇨🇦 Toronto, Ontario, Canada
Boehringer IngelheimContact
Dr. M. B. Jones Inc.🇨🇦 Victoria, British Columbia, Canada
Boehringer IngelheimContact
Diex Recherche (Victoriaville)🇨🇦 Victoriaville, Quebec, Canada
Boehringer IngelheimContact
Huzhou Central Hospital🇨🇳 Huzhou, China
Boehringer IngelheimContact
Center Hospital of Jinan🇨🇳 Jinan, China
Boehringer IngelheimContact
The First Affiliated Hospital of Henan University of Science and Technology🇨🇳 Luoyang, China
Boehringer IngelheimContact
The Second Affiliated Hospital of Nanjing Medical University🇨🇳 Nanjing, China
Boehringer IngelheimContact
The First Affiliated Hospital of Ningbo University🇨🇳 Ningbo, China
Boehringer IngelheimContact
First Hospital of Qinhuangdao🇨🇳 Qinhuangdao, China
Boehringer IngelheimContact
Tianjin Medical University Chu Hisen-I Memorial Hospital🇨🇳 Tianjin, China
Boehringer IngelheimContact
Yichang Central People's Hospital🇨🇳 Yichang, China
Boehringer IngelheimContact
Waitemata Clinical Research🇳🇿 Auckland, New Zealand
Boehringer IngelheimContact
Momentum Clinical Research Dunedin🇳🇿 Central Dunedin, Dunedin, New Zealand
Boehringer IngelheimContact
Momentum Clinical Research Wellington🇳🇿 Mount Cook, Wellington Region, New Zealand
Boehringer IngelheimContact
Fylde Coast Clinical Research🇬🇧 Blackpool, United Kingdom
Boehringer IngelheimContact
The Garth Surgery🇬🇧 Guisborough, United Kingdom
Boehringer IngelheimContact
Velocity Clinical Research, High Wycombe🇬🇧 High Wycombe, United Kingdom
Boehringer IngelheimContact
Leicester General Hospital🇬🇧 Leicester, United Kingdom
Boehringer IngelheimContact
Linthorpe Surgery🇬🇧 Middlesbrough, United Kingdom
Boehringer IngelheimContact
Banbury Cross Health Centre🇬🇧 Oxford, United Kingdom
Boehringer IngelheimContact
Texas Diabetes and Endocrinology🇺🇸 Austin, Texas, United States
Boehringer IngelheimContact
Cahaba Research, Inc. - Trussville Location🇺🇸 Birmingham, Alabama, United States
Boehringer IngelheimContact
South Texas Research Institute - Brownsville🇺🇸 Brownsville, Texas, United States
Boehringer IngelheimContact
StudyMetrix Research, LLC🇺🇸 City of Saint Peters, Missouri, United States
Boehringer IngelheimContact
South Texas Research Institute-Edinburg-67012🇺🇸 Edinburg, Texas, United States
Boehringer IngelheimContact