A Study of DA-302168S in Participants With Overweight/Obesity

NCT07629544 | Not Yet Recruiting Phase 3

• 1 other identifier: 2026-CP-DA168-09
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• Percentage change from baseline in body weight

  From baseline to week 40

• The proportion of subjects with a body weight reduction ≥5% from baseline

  From baseline to week 40

Secondary Outcomes (9)

• The proportion of subjects with a body weight reduction of ≥10% and ≥15%

  From baseline to week 40

• Percentage change from baseline in body weight

  From baseline to week 52

• The proportion of subjects with a body weight reduction ≥5%、10%、15% from baseline

  From baseline to week 52

• Changes from baseline in hip circumference

  From baseline to week 40 and week 52

• Changes from baseline in blood glucose levels

  From baseline to week 52

Study Arms (3)

High dose group

ACTIVE COMPARATOR

Participants will receive DA-302168S orally once daily, starting with a dose of 2.5 mg and gradually titrated up to the target dose.

Drug: DA-302168S

Low dose group

ACTIVE COMPARATOR

Participants will receive DA-302168S orally once daily, starting with a dose of 2.5 mg and gradually titrated up to the target dose.

Drug: DA-302168S

Placebo group

PLACEBO COMPARATOR

Participants will receive placebo tablets orally, once daily

Drug: Placebo

Interventions

DA-302168S DRUG

A small molecule GLP-1R agonist tablet, orally administration, once daily

High dose group

Placebo DRUG

Matching placebo tablet will be provided

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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);
• 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);
• 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;
• Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
• 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;
• 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.

Sponsors & Collaborators

• Chendu DIAO Pharmaceutical Group CO., LTD.: lead
• Peking University People's Hospital: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): June 27, 2026
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): October 19, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)