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A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight/Obese Subjects | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight/Obese Subjects

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study To Evaluate The Efficacy And Safety Of DA-302168S Tablets In Overweight/Obese Subjects

NCT06953063•Chendu DIAO Pharmaceutical Group CO., LTD.

View on ClinicalTrials.gov

Summary

It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety and efficacy of DA-302168S tablets in overweight and obese adults.

Detailed Description

The goal of the study is to assess how DA-302168S tablets affect the bodyweight when used once daily in obese or overweight adult participants. Qualified participants will be randomly assigned to one of five groups using a computerized system. Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a treatment period will be 16 weeks, followed by an approximate 2-week follow-up.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age range:18-75 years old (inclusive),regardless of gender;
•2. BMI requirements at screening:obese patients, BMI \>28 kg/m2 with or without comorbidities; or, overweight patients, BMI =24.0 kg/m2 but 28 kg/m2 with at least one；
•3. Weight change (weight change \[maximum weight-minimum weight\] /maximum weight;based on subject self-report)did not exceed 5%during the 3 months before screening under diet and exercise control;

Exclusion Criteria

•1. Secondary obesity: including obesity previously diagnosed as endocrine disease or caused by single gene mutation (including but not limited to hypothalamic obesity, pituitary obesity, Cushing's syndrome, hypothyroidism, islet cell tumor, acromegaly, hypogonadism, polycystic ovary syndrome, etc.) or drug-induced obesity (such as glucocorticoids, tricyclic antidepressants, atypical antipsychotics, etc.)
•2. Those who have undergone weight loss surgery in the past (except for acupuncture weight loss, liposuction and abdominal fat removal surgery one year before screening), or plan to undergo surgery for obesity during the study period, such as gastric bypass, gastric banding, etc.;
•3. The patient has clinically cardiovascular and cerebrovascular diseases, including but not limited to the following cardiovascular and cerebrovascular diseases or conditions within 6 months before signing the ICF: a. Unstable angina pectoris; b. Heart failure (New York Heart Association heart function grade III or IV); c. Myocardial infarction; d. Coronary artery bypass grafting or percutaneous coronary intervention; e. Uncontrolled severe arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block, etc.; f. Cerebrovascular accident, such as cerebral infarction, transient ischemic attack, etc.
•4. Those who had acute pancreatitis 3 months before signing the ICF, or had a history of chronic pancreatitis or pancreatic injury, which may be high-risk factors for pancreatitis;
•5. Individuals who have experienced acute cholecystitis in the 3 months prior to signing the ICF, or have cholecystitis/cholangitis/bile duct stones/multiple gallstones at screening, or have been assessed by researchers as having gallbladder-related diseases that may lead to a high incidence of cholecystitis during screening;
•6. Sufering from any malignant tumor within 5 years before signing the ICF (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
•7. A history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2;
•8. Patients with a history of thyroid dysfunction who still require medication during screening, or with clinically significant abnormal thyroid function results during screening, or with thyroid nodules assessed by researchers as having safety risks during screening.;
•9. Those who have experienced severe hypoglycemia or repeated symptomatic hypoglycemia (≥2 times within half a year) in the past (severe hypoglycemia is defined as: severe events accompanied by changes in consciousness and/or body, hypoglycemia that requires help from others);
•10. Those with a specific allergy history that, as assessed by the investigator, will significantly affect the safety of the subjects (such as asthma, urticaria, eczema, etc.) or allergic constitution, or those who are allergic to any component of the trial drug or preparation, or those who are allergic to other glucagon-like peptide-1 receptor agonist (GLP-1RA) drugs or drugs with a glucagon-like peptide-1 (GLP-1) receptor stimulating mechanism;
+3 more criteria

Locations (1)

Peking University People's Hospital

Beijing, China

Key Dates

Start Date

May 15, 2025

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

June 26, 2025

Enrollment

240

ESTIMATED participants

Conditions

Overweight and Obesity

Interventions

DA-302168S

DRUG

Placebo of DA-302168S

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight/Obese Subjects

Inclusion Criteria

Exclusion Criteria

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