A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorBoehringer Ingelheim
About this trial
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
Qualifiers
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
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.
History of at least one self-reported unsuccessful dietary effort to lose body weight
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
Disqualifiers
Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening
Treatment with anti-obesity medication and/or body weight change-inducing medication within 3 months before screening
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
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)
Trial design
Treatments tested in this trial
- BI 3034701
- Placebo matching BI 3034701
Treatment groups
300 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov