A Study of DA-302168S in Participants With Overweight/Obesity (PANDA-1)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight/Obese Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Drug: DA-302168S; Drug: Placebo

Detailed Description

This study will be divided into three phases: a screening period (up to 2 weeks), a treatment period (52 weeks), and a safety follow-up period (2 weeks). The study plans to enroll approximately 840 participants. Eligible participants will be randomly assigned in a 1:1:1 ratio to the 10 mg dose group, the 20 mg dose group, or the placebo group, with each dose group planned to enroll about 280 participants. During the treatment period, all participants should adhere to dietary and exercise control, with guidance on diet and energy intake provided by authorized nutritionists or investigators.

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University People's Hospital
    • Contact: Ji linong; Email: jiln@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Participants will receive placebo tablets orally, once daily	Drug: Placebo; Matching placebo tablet will be provided
Active Comparator: High dose group; 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; A small molecule GLP-1R agonist tablet, orally administration, once daily
Active Comparator: Low dose group; 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; A small molecule GLP-1R agonist tablet, orally administration, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Percentage change from baseline in body weight	From baseline to week 52
The proportion of subjects with a body weight reduction of ≥10% and ≥15%	From baseline to week 40
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
Changes from baseline in blood lipid levels	From baseline to week 52
Changes from baseline in blood pressure levels	From baseline to week 52
Changes from baseline in the SF-36 V2	From baseline to week 52
Changes from baseline in the IWQoL-Lite-CT	From baseline to week 52

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 27, 2026
• Primary Completion (Estimated): July 9, 2027
• Study Completion (Estimated): October 19, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 2026-CP-DA168-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No