About this trial
This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aimed at evaluating the efficacy, safety, and pharmacokinetic (PK) characteristics of DA-302168S tablets in overweight or obese participants in China.
Eligibility criteria
Qualifiers
Age 18-75 years (inclusive), both males and females;
BMI requirements at screening: for obese participants, BMI ≥28 kg/m² with or without comorbidities; or for overweight participants, BMI ≥24.0 kg/m² and <28 kg/m² with at least one of the following comorbidities: hypertension, prediabetes, dyslipidemia, weight-bearing joint pain (as determined by the investigator, excluding joint pain caused by other diseases), obstructive sleep apnea syndrome, or metabolic dysfunction-associated steatotic liver disease;
Body weight change <5% (based on participant self-report, calculated as [maximum weight - minimum weight] / maximum weight, with the result rounded to one significant digit) during the 3 months prior to screening, while on diet and exercise control (based on participant self-report).
Disqualifiers
Type 1 diabetes, type 2 diabetes, or other specific types of diabetes (excluding gestational diabetes);
Secondary obesity, history of bariatric surgery;
Presence of gastrointestinal diseases affecting drug absorption, dysphagia;
Personal/family history of medullary thyroid carcinoma, C-cell hyperplasia, or multiple endocrine neoplasia type 2; uncontrolled hyperthyroidism or hypothyroidism without standard stable management; thyroid nodule with TI-RADS grade 4 or above;
Trial design
Treatments tested in this trial
- DA-302168S
- DA-302168S
- Placebo
Treatment groups
Sponsors and collaborators
Chendu DIAO Pharmaceutical Group CO., LTD.
Lead sponsor
Peking University People's Hospital
Collaborator