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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
307
once weekly subcutaneous injection
Once weekly subcutaneous injection
Beijing Chao-Yang Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Beijing Pinggu Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
The Second Hospital of Jilin University
Changchun, China
Changzhou Second People's Hospital
Changzhou, China
People's Hospital of Sichuan Province
Chengdu, China
Second Affiliated Hospital Chongqing Medical University
Chongqing, China
NanFang Hosptial
Guangzhou, China
Forth Clinical Hospital of Harbin Medical University
Harbin, China
...and 18 more locations
Percentage change in body weight from baseline to Week 52
Time frame: At baseline and at Week 52.
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52
Time frame: At baseline and at Week 52.
Key secondary endpoint: Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52
Time frame: At baseline and at Week 52
Key secondary endpoint: Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 52
Time frame: At baseline and at Week 52
Key secondary endpoint: Absolute change from baseline to Week 52 in waist circumference (cm)
Time frame: At baseline and at Week 52
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in body weight (kg)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in glycosylated haemoglobin A1c (HbA1c) (%)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in HbA1c (mmol/mol)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in systolic blood pressure (SBP) (mmHg)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in diastolic blood pressure (DBP) (mmHg)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in body mass index (BMI) (kg/m^2)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in fasting plasma glucose (FPG) (mg/dL)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in fasting plasma insulin (FPI) (mIU/L)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in total cholesterol (mg/dL)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in high-density lipoprotein (HDL) cholesterol (mg/dL)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in low-density lipoprotein (LDL) cholesterol (mg/dL)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in very low-density lipoprotein (VDL) cholesterol (mg/dL)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in triglycerides (mg/dL)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in free fatty acids (mg/dL)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in alanine aminotransferase (ALT) (U/L)
Time frame: At baseline and at Week 52
Absolute change from baseline to Week 52 in aspartate aminotransferase (AST) (U/L)
Time frame: At baseline and at Week 52
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