DA-302168S in adults with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind study compares DA-302168S at 10 mg and 20 mg doses to placebo over 52 weeks in adults aged 18–75 with overweight or obesity. Participants will undergo a 2-week screening, a 52-week treatment period with dietary and exercise guidance, and a 2-week safety follow-up, totaling about 56 weeks. Approximately 840 participants across three arms will be enrolled, with 280 per active-dose group and 280 in placebo, in China. Primary aims include evaluating weight loss efficacy, safety, and pharmacokinetics, while all participants receive structured lifestyle counseling during treatment.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Age 18-75 years (inclusive), both males and females;
2. 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;
3. 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).

Exclusion Criteria:

1. Type 1 diabetes, type 2 diabetes, or other specific types of diabetes (excluding gestational diabetes);
2. Secondary obesity, history of bariatric surgery;
3. Presence of gastrointestinal diseases affecting drug absorption, dysphagia;
4. 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;
5. History of acute pancreatitis, chronic pancreatitis, or pancreatic injury within 6 months prior to screening (high-risk pancreatic conditions); acute cholecystitis within the past 3 months, or current cholecystitis, cholangitis, cholelithiasis, or other high-risk gallbladder diseases (except for those with prior cholecystectomy and judged eligible by the investigator);
6. Severe unstable psychiatric disorder, depression, or history of suicide attempt; score ≥15 on the Patient Health Questionnaire-9 (PHQ-9) at screening, or presence of suicidal ideation/suicidal behavior indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS);
7. Any of the following abnormal clinical laboratory results (local laboratory) at screening: anemia (hemoglobin \<110 g/L for males, \<100 g/L for females); liver enzymes, bilirubin, amylase, or lipase exceeding the specified multiples of the upper limit of normal; calcitonin ≥50 ng/L (pg/mL); estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m²; triglycerides \>5.65 mmol/L; thyroid-stimulating hormone \>6 mIU/L or \<0.4 mIU/L;
8. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
9. Abnormal heart rate on resting electrocardiogram, atrioventricular block, prolonged QTcF interval, bundle branch block, or other clinically significant arrhythmias; history of myocardial infarction, unstable angina, severe cardiac insufficiency, coronary intervention/bypass, or other cardiovascular/cerebrovascular diseases within 6 months prior to enrollment;
10. Use of weight-loss drugs or weight-loss herbal medicines, any hypoglycemic agents, antidepressants, antipsychotics, antiepileptics, or lithium salts within 3 months prior to screening; use of systemic glucocorticoids (except for continuous cumulative use \<7 days); active autoimmune disease requiring systemic glucocorticoid therapy during the study period.

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.