About this trial
To evaluate the efficacy and safety of SYH2069 injection compared with placebo in obese Non-diabetic Participants after 28 weeks of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1.Male or female participants, 18-65 years of age at the time of signing informed consent;
2.At screening visit, 28.0 kg/m²≤BMI≤ 40.0 kg/m²;
3.Maintained consistent diet and exercise habits with stable body weight within the 12 weeks prior to screening (self-reported weight variation <5%).;
4.Able to understand and comply with trial procedures, voluntarily participate in the trial, and provide written informed consent (ICF).
Disqualifiers
1. Participants with a history of diabetes mellitus or hypoglycemic episodes;
2. Participants with obesity caused by known single-gene mutations, other medical conditions, or medications, or weight gain not resulting from increased adipose tissue mass;
3. Use of any medications or products that alter body weight and interfere with weight assessment within 3 months prior to screening;
4. Prior bariatric surgery or weight-loss interventions, or plan to receive any bariatric surgery or weight-loss intervention during the trial.
Trial design
Parallel
Treatments tested in this trial
SYH2069 Injection
Drug0.6ml , 1.2ml , administered subcutaneously (SC),Administer the drug according to the clinical trial protocol
SYH2069 Injection Placebo
Drug0.6ml , 1.2ml , SC,Administer the drug according to the clinical trial protocol
Treatment groups
9
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Relative percentage change in body weight from baseline at of treatment at 28 weeks of treatment
Secondary outcomes
Proportion of subjects with a weight loss of ≥5% , 10%, 15% from baseline at 28 weeks of treatment
Change from baseline in body Weight
Changes from baseline in waist circumference
Changes from baseline in hip circumference
Sponsors and contacts
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