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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
342
BI 3034701
Placebo matching BI 3034701
Cahaba Research, Inc. - Trussville Location
Birmingham, Alabama, United States
Focus Clinical Research
West Hills, California, 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
Percentage change in body weight from baseline at Week 42 [%]
Time frame: Baseline and at Week 42.
Achievement of weight loss of ≥5% of baseline weight at Week 42
Time frame: Baseline and at Week 42.
Achievement of weight loss of ≥10% of baseline weight at Week 42
Time frame: Baseline and at Week 42.
Achievement of weight loss of ≥15% of baseline weight at Week 42
Time frame: Baseline and at Week 42.
Achievement of weight loss of ≥20% of baseline weight at Week 42
Time frame: Baseline and at Week 42.
Absolute change from baseline at Week 42 in body weight [kg]
Time frame: Baseline and at Week 42.
Absolute change from baseline at Week 42 in waist circumference [cm]
Time frame: Baseline and at Week 42.
Absolute change from baseline at Week 42 in waist-to-height ratio (WHtR) [dimensionless ratio]
Time frame: Baseline and at Week 42.
Absolute change from baseline at Week 42 in systolic blood pressure (SBP) [mmHg]
Time frame: Baseline and at Week 42.
Absolute change from baseline at Week 42 in diastolic blood pressure (DBP) [mmHg]
Time frame: Baseline and at Week 42.
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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
...and 44 more locations