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

August 4, 2026 updated by: Chendu DIAO Pharmaceutical Group CO., LTD.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
840

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage change from baseline in body weight
Time Frame: From baseline to week 40
From baseline to week 40
The proportion of subjects with a body weight reduction ≥5% from baseline
Time Frame: From baseline to week 40
From baseline to week 40

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage change from baseline in body weight
Time Frame: From baseline to week 52
From baseline to week 52
The proportion of subjects with a body weight reduction of ≥10% and ≥15%
Time Frame: From baseline to week 40
From baseline to week 40
The proportion of subjects with a body weight reduction ≥5%、10%、15% from baseline
Time Frame: From baseline to week 52
From baseline to week 52
Changes from baseline in hip circumference
Time Frame: From baseline to week 40 and week 52
From baseline to week 40 and week 52
Changes from baseline in blood glucose levels
Time Frame: From baseline to week 52
From baseline to week 52
Changes from baseline in blood lipid levels
Time Frame: From baseline to week 52
From baseline to week 52
Changes from baseline in blood pressure levels
Time Frame: From baseline to week 52
From baseline to week 52
Changes from baseline in the SF-36 V2
Time Frame: From baseline to week 52
From baseline to week 52
Changes from baseline in the IWQoL-Lite-CT
Time Frame: From baseline to week 52
From baseline to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chendu DIAO Pharmaceutical Group CO., LTD.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 19, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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