Overweight and obesity are long-term health conditions that can increase the risk of serious health problems, including heart disease, type 2 diabetes, and other medical conditions. The purpose of this study is to learn whether berobenatide is safe and effective for adults in China who have overweight or obesity. Researchers will compare berobenatide with a placebo, which looks like the study treatment but does not contain active medicine. People may be able to participate if they are adults with obesity or if they have overweight together with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment. Participants will be randomly assigned to receive either berobenatide or placebo. The study treatment will be administered according to the study protocol, and participants will be monitored throughout the study to assess changes in body weight and overall health, as well as any side effects that may occur. During participation, participants will attend study visits and complete study-related assessments. Researchers will collect information about participants' health, body weight, and safety throughout the study. Details about the number of visits, study duration, and study procedures will be explained by the study team before participation. The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Solution for injection
Solution for injection
The Second People's Hospital of Hefei
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Percent Change From Baseline in Body Weight at Week 48
Time frame: Baseline to Week 48
Change From Baseline in Body Weight at Week 48
Time frame: Baseline to Week 48
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Time frame: Baseline, Week 48
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Time frame: Baseline, Week 48
Change from baseline in waist circumference
Time frame: Baseline, Week 48
Change from baseline in Non-High-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from baseline in Fasting triglycerides
Time frame: Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 48
Change from baseline in Short Form 36 health survey (SF-36) Physical Function domain score
Time frame: Baseline, Week 48
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
Time frame: Baseline, Week 48
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 48
Change from baseline in Fasting Total Cholesterol
Time frame: Baseline, Week 48
Change from baseline in Low-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from baseline in Very low-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from baseline in High-density lipoprotein cholesterol
Time frame: Baseline, Week 48
Change from Baseline in HbA1c
Time frame: Baseline, Week 48
Change from baseline in Fasting Plasma Glucose
Time frame: Baseline, Week 48
Change from baseline in Fasting Insulin
Time frame: Baseline, Week 48
Change from baseline in hs-CRP (high-sensitivity C-reactive protein)
Time frame: Baseline, Week 48
Change from baseline in Interleukin-6 (IL-6)
Time frame: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Physical Composite
Time frame: Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
Time frame: Baseline, Week 48
Change from baseline in SF-36 domain scales and component summary scales
Time frame: Baseline, Week 48
Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score
Time frame: Baseline, Week 48
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: Baseline, Week 48
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 58
Number of participants with Serious Adverse Events (SAE)
Time frame: Up to Week 58
Number of participants with AE leading to permanent discontinuation from study intervention or study
Time frame: Up to Week 58
Percentage of participants with T2D at screening achieving HbA1c <7.0%
Time frame: Up to Week 48
Percentage of participants with Type 2 diabetes (T2D) at screening achieving HbA1c <5.7%
Time frame: Up to Week 48
Change from Baseline in Body mass index (BMI)
Time frame: Baseline, Week 48
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