Placebo matching BI 3034701: Placebo matching BI 3034701
Study 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
Sex
ALL
Min age
18 Years
Max age
74 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Percentage change in body weight from baseline at Week 42 [%] — Baseline and at Week 42.
Trial sites (54)
Facility
City
Region
Status
Cahaba Research, Inc. - Trussville Location
Birmingham
Alabama
Focus Clinical Research
West Hills
California
Optimus U Corporation-Miami-69452
Miami
Florida
Javara-Fayetteville-67354
Fayetteville
Georgia
Monroe Biomedical Research - Louisville
Louisville
Kentucky
Arcturus Healthcare - Troy Internal Medicine Research Division
Troy
Michigan
StudyMetrix Research, LLC
City of Saint Peters
Missouri
Clinvest Research LLC
Springfield
Missouri
Centricity Research - Morehead City
Morehead City
North Carolina
Accellacare-Wilmington-67123
Wilmington
North Carolina
Lillestol Research, LLC
Fargo
North Dakota
Tribe Clinical Research at Parkside OB-GYN, Greer
Greer
South Carolina
Texas Diabetes and Endocrinology
Austin
Texas
South Texas Research Institute - Brownsville
Brownsville
Texas
South Texas Research Institute-Edinburg-67012
Edinburg
Texas
IMA Clinical Research San Antonio
San Antonio
Texas
Data Point Clinical, LLC
Kirkland
Washington
Rainier Clinical Research Center
Renton
Washington
Allegiance Research Specialists
Wauwatosa
Wisconsin
Coastal Digestive Health & CDH Research Institute
Maroochydore
Queensland
Southern Adelaide Diabetes and Endocrine Services (SADES)
Oaklands Park
South Australia
Eastern Health-Box Hill Hospital
Box Hill
Victoria
Ocean West Research Clinic (Surrey)
Surrey
British Columbia
Hilltop Medical Clinic
Surrey
British Columbia
Dr. M. B. Jones Inc.
Victoria
British Columbia
Apex Trials (Guelph)
Guelph
Ontario
Winterberry Research Inc.
Hamilton
Ontario
The Wharton Medical Clinic Clinical Trials Inc.
Hamilton
Ontario
Milestone Research Inc.
London
Ontario
Stouffville Medical Research Institute Inc.
Stouffville
Ontario
Canadian Phase Onward Inc.
Toronto
Ontario
Ecogene-21
Chicoutimi
Quebec
THEO Medical (Montreal)
Montreal
Quebec
Centre Medical Acadie (9109-0126 Quebec Inc)
Montreal
Quebec
Diex Recherche (Sherbrooke Est)
Sherbrooke
Quebec
Diex Recherche (Victoriaville)
Victoriaville
Quebec
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
+ 14 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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