Overweight and ObesityPhase 3PANDA-1NCT07629544
A Study of DA-302168S in Participants With Overweight/Obesity
A Phase 3 study testing DA-302168S in people with Overweight and Obesity, run by Chendu DIAO Pharmaceutical Group CO., LTD. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- DA-302168S
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 840 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2026to 19 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Ji linong, 13910978815, jiln@bjmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- DA-302168S, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-302168SDrug
A small molecule GLP-1R agonist tablet, orally administration, once daily
DA-302168SDrug
A small molecule GLP-1R agonist tablet, orally administration, once daily
PlaceboDrug
Matching placebo tablet will be provided
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: DA-302168S |
| Placebo group | Placebo comparator | Participants will receive placebo tablets orally, once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in body weight
Measured: From baseline to week 40
The proportion of subjects with a body weight reduction ≥5% from baseline
Measured: From baseline to week 40
Secondary outcomes (9)
The proportion of subjects with a body weight reduction of ≥10% and ≥15%
Measured: From baseline to week 40
Percentage change from baseline in body weight
Measured: From baseline to week 52
The proportion of subjects with a body weight reduction ≥5%、10%、15% from baseline
Measured: From baseline to week 52
Changes from baseline in hip circumference
Measured: From baseline to week 40 and week 52
Changes from baseline in blood glucose levels
Measured: From baseline to week 52
Changes from baseline in blood lipid levels
Measured: From baseline to week 52
Changes from baseline in blood pressure levels
Measured: From baseline to week 52
Changes from baseline in the SF-36 V2
Measured: From baseline to week 52
Changes from baseline in the IWQoL-Lite-CT
Measured: From baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start19 Jun 2026
- Primary completion9 Jul 2027 (estimated)
- Study completion19 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629544
- Sponsor's protocol ID
- 2026-CP-DA168-09
- Acronym
- PANDA-1
- Status last verified
- Aug 2026
- First submitted
- 27 May 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07629544
- Acronym / sponsor ID
- PANDA-1 / 2026-CP-DA168-09
- Conditions
- Overweight and Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Peking University People's Hospital
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 9 Jul 2027 (estimated)
- Study completion
- 19 Oct 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose group | Active comparator | Drug: DA-302168SParticipants will receive DA-302168S orally once daily, starting with a dose of 2.5 mg and gradually titrated up to the target dose. |
| Low dose group | Active comparator | Drug: DA-302168SParticipants will receive DA-302168S orally once daily, starting with a dose of 2.5 mg and gradually titrated up to the target dose. |
| Placebo group | Placebo comparator | Drug: PlaceboParticipants will receive placebo tablets orally, once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-302168SA small molecule GLP-1R agonist tablet, orally administration, once daily | Drug | High dose group |
| DA-302168SA small molecule GLP-1R agonist tablet, orally administration, once daily | Drug | Low dose group |
| PlaceboMatching placebo tablet will be provided | Drug | Placebo group |
Primary outcome
Percentage change from baseline in body weight
Time frame: From baseline to week 40
The proportion of subjects with a body weight reduction ≥5% from baseline
Time frame: From baseline to week 40
9 secondary outcomes
The proportion of subjects with a body weight reduction of ≥10% and ≥15%
Time frame: From baseline to week 40
Percentage change from baseline in body weight
Time frame: From baseline to week 52
The proportion of subjects with a body weight reduction ≥5%、10%、15% from baseline
Time frame: From baseline to week 52
Changes from baseline in hip circumference
Time frame: From baseline to week 40 and week 52
Changes from baseline in blood glucose levels
Time frame: From baseline to week 52
Changes from baseline in blood lipid levels
Time frame: From baseline to week 52
Changes from baseline in blood pressure levels
Time frame: From baseline to week 52
Changes from baseline in the SF-36 V2
Time frame: From baseline to week 52
Changes from baseline in the IWQoL-Lite-CT
Time frame: From baseline to week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DA-302168S in people with Overweight and Obesity, run by Chendu DIAO Pharmaceutical Group CO., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in body weight (time frame: From baseline to week 40). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.