A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Ob… (NCT06214741) | Clinical Trial Compass
CompletedPhase 3
A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
China307 participantsStarted 2024-02-06
Plain-language summary
This study in China is open to adults who are at least 18 years old who are living with overweight or obesity. People with a body mass index (BMI) of 28 kg/m\^2 or higher or 24 kg/m\^2 or higher with at least 1 weight related problem can join the study. The main purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity. 2 different doses of survodutide are tested in this study.
Participants are put into 3 groups by chance. Each participant has an equal chance of being in each group. 2 groups get different doses of survodutide. 1 group gets placebo. Participants get survodutide or placebo as injections under the skin once a week for about 19 months.
Placebo injections look like survodutide injections but do not contain any medicine.
Participants are in the study for about 21 months. During this time, there are 20 visits. 14 visits are in person at the study site. Where possible, 6 visits can be done by video call, or by phone in rare cases. During this time, doctors regularly measure participant's body weight. Results are compared between the survodutide groups and placebo group to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, age ≥18 years at the time of signing informed consent.
✓. Body mass index (BMI) ≥28 kg/m\^2 at screening, OR BMI ≥24 kg/m\^2 at screening with the presence of at least one of the following weight-related complications:
✓. History of at least one self-reported unsuccessful dietary effort to lose body weight
✓. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
✓. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per 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.
Exclusion criteria
✕. Body weight change (self-reported) \>5% within 3 months before screening.
✕. Treatment with any medication for the indication obesity within 3 months before screening.
What they're measuring
1
Percentage change in body weight from baseline to Week 52
Timeframe: At baseline and at Week 52.
2
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52
✕. Previous or planned (during the trial period) treatment for obesity with surgery or a weight loss device, or prior surgery of the GI tract that could interfere with body weight 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) duodenal-jejunal bypass sleeve, if the sleeve has been removed \>1 year before screening, (5) appendectomy, (6) simple hernia repair, or (7) cholecystectomy
✕. 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) (B) Diabetes-related for participants with T2DM:
✕. Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before screening (i.e. insulin, amylin analogues, glucagon-like peptide-1 receptor (GLP- 1R)) agonists, GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations, and dipeptidyl peptidase 4 inhibitor (DPP-4i))
✕. New initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial
✕. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, verified by an eye examination within 3 months prior to screening or in the period between screening and randomisation Further exclusion criteria apply.