Overweight and ObesityPhase 2DA168NCT06953063
A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Overweight/Obese Subjects
A Phase 2 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
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. 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
- 250 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 15 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 range:18-75 years old (inclusive),regardless of gender;
- 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；
- 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;
Who cannot join
- 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.)
- 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.;
- 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.
- 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;
- 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;
- 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);
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- A history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2;
- 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.;
- 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);
- 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;
- HbA1c ≥ 6.5%, or FPG ≥ 7.0 mmol/L or ≤ 3.9 mmol/L at screening, or patients previously diagnosed with type 1 diabetes, type 2 diabetes, or other special types of diabetes (according to the diabetes diagnosis and classification criteria issued by the World Health Organization [WHO] in 2019;
- Those with a history of moderate to severe depression, anxiety, or severe mental illness, or those with a depression screening scale (PHQ-9) score ≥ 15 at screening (see Appendix 3 for details); 13 Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, including but not limited to gastrectomy or any intestinal resection, severe gastrointestinal disease, clinically obvious gastric emptying abnormalities, etc.;
- 14.People who are lactose intolerant (for example, those who have had diarrhea after drinking milk within the shelf life); 15.During screening, the clinical laboratory test (local laboratory) results showed any of the following abnormalities (rechecked and confirmed once within 1 week if necessary): 1) hemoglobin <100 g/L for females and <110 g/L for males; alanine aminotransferase (ALT) ≥2.0×upper limit of normal (ULN); 2) aspartate aminotransferase (AST) ≥2.0×ULN; 3) total bilirubin (TBIL) ≥1.5×ULN; 4) blood amylase or blood lipase >1.5×ULN; 5) calcitonin ≥1.0×ULN; 6) estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 [Chronic Kidney Disease Epidemiology Institute (CKD-EPI) formula, see Appendix 4 for details]; 7) TG >500 mg/dl (5.65 mmol/L); 8) thyroid stimulating hormone >6 mIU/L or <0.4 mIU/L; 16.Uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100 mmHg; 17.During screening, 12-lead ECG examinations were performed three times in the supine position at rest, and the average corrected QT interval (corrected according to Fridericia's formula, see Appendix 5 for details) obtained from the three measurements was >450 msec; 18.Those with a history of drug abuse in the past five years or who had used drugs in the three months before screening; 19 Received any GLP-1 RA before screening (including GLP-1R agonists, GLP-1R related multitarget agonists, or compound preparations containing GLP-1R agonists, etc.); 20.Female subjects who are pregnant or breastfeeding, or have a positive pregnancy test; 21.Drugs that may affect body weight were used within 3 months before screening, including: dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulin, metformin, insulin secretagogues, or thiazolidinedione (TZD) and other hypoglycemic drugs; any approved or unapproved weight loss drugs, such as orlistat, Lorcaserin, phentermine/topiramate, naltrexone/bupropion, etc.) or Chinese herbal medicines, health products, meal replacements, etc. that affect body weight; systemic steroid hormones (intravenous, oral or intra-articular); tricyclic antidepressants, antipsychotics or anti-epileptic drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts), etc.; Note: Except for those who have used systemic hormones for less than 7 days cumulatively or continuously; 22.Active autoimmune diseases (such as lupus, rheumatoid arthritis), who may be treated with systemic glucocorticoids during the study period as determined by the investigator; 23.Participants who have participated in clinical trials of other drugs within the previous 3 months and received the investigational drug (excluding those who received a placebo); 24. Those who donated blood or lost ≥400 mL of blood, received blood transfusion, or used blood products within 3 months before screening; 25 Heavy smokers or those who smoked ≥5 cigarettes per day on average within 3 months before screening; 26 Heavy drinkers or regular drinkers within 3 months before screening, that is, drinking more than 14 standard units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine); 27 Patients with positive results in any of the tests for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab)or Treponema pallidum antibody (TP-Ab); patients with hepatitis B who are HBsAg negative but are undergoing antiviral treatment; 28 The investigator believes that there are other factors that may affect the evaluation of relevant indicators of the effectiveness and safety of this study and make the subject unsuitable for participation in this clinical trial (including but not limited to the investigator's judgment that the subject's compliance is poor, or the subject lives too far away and cannot be followed up as scheduled, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- DA-302168S, Placebo of DA-302168S
- Keywords
- Overweight and Obesity, GLP-1
- 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，16weeks.
Placebo of DA-302168SDrug
Matching placebo tablet will be provided
| Study group | Role | What they receive |
|---|---|---|
| DA-302168S | Experimental | 5mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks.
10mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks.
20mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks.
30mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Receives: Drug: DA-302168S |
| Placebo of DA-302168S | Placebo comparator | 5mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks.
10mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks.
20mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks.
30mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. Receives: Drug: Placebo of DA-302168S |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change in body weight
percentage-point
Measured: From baseline (week1) to week16
Secondary outcomes (12)
Proportion of subjects with weight decrease ≥ 5%
percentage-point
Measured: From baseline (week 1) to week 16
Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
Count of events
Measured: From baseline (week 1) to week 18
Proportion of subjects with weight decrease ≥ 10%
percentage-point
Measured: From baseline (week 1) to week 16
Absolute change in body mass index (BMI)
measured in kg/m^2
Measured: From baseline (week 1) to week 16
Absolute change in waist circumference
measured in cm
Measured: From baseline (week 1) to week 16
Absolute change in hip circumference
measured in cm
Measured: From baseline (week 1) to week 16
Change in blood lipid profiles (TC, TG, LDL-C, and HDL-C)
measured in mmol/L
Measured: From baseline (week 1) to week 16
Change in fasting plasma glucose (FPG)
measured in mmol/L
Measured: From baseline (week 1) to week 16
Change in HbA1c (glycated haemoglobin)
percentage-point
Measured: From baseline (week 1) to week 16
Change in fasting insulin
measured in μIU/mL
Measured: From baseline (week 1) to week 16
Change in HOMA-IR
point
Measured: From baseline (week 1) to week 16
Blood pressure (systolic and diastolic)
measured in mmHg
Measured: From baseline (week 1) to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 May 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953063
- Sponsor's protocol ID
- 2024-CP-DA168-06
- Acronym
- DA168
- Status last verified
- May 2026
- First submitted
- 11 Apr 2025
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06953063
- Acronym / sponsor ID
- DA168 / 2024-CP-DA168-06
- Conditions
- Overweight and Obesity
- Keywords
- Overweight and Obesity, GLP-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.Industry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 1 May 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-302168S | Experimental | Drug: DA-302168S5mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. 10mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. 20mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. 30mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. |
| Placebo of DA-302168S | Placebo comparator | Drug: Placebo of DA-302168S5mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. 10mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. 20mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. 30mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. |
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 range:18-75 years old (inclusive),regardless of gender;
- 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；
- 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;
Key exclusion criteria (13 listed)
- 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.)
- 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.;
- 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.
- 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;
- 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;
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，16weeks. | Drug | DA-302168S |
| Placebo of DA-302168SMatching placebo tablet will be provided | Drug | Placebo of DA-302168S |
Primary outcome
percentage change in body weight
Time frame: From baseline (week1) to week16
percentage-point
12 secondary outcomes
Proportion of subjects with weight decrease ≥ 5%
Time frame: From baseline (week 1) to week 16
Adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs)
Time frame: From baseline (week 1) to week 18
Proportion of subjects with weight decrease ≥ 10%
Time frame: From baseline (week 1) to week 16
Absolute change in body mass index (BMI)
Time frame: From baseline (week 1) to week 16
Absolute change in waist circumference
Time frame: From baseline (week 1) to week 16
Absolute change in hip circumference
Time frame: From baseline (week 1) to week 16
Change in blood lipid profiles (TC, TG, LDL-C, and HDL-C)
Time frame: From baseline (week 1) to week 16
Change in fasting plasma glucose (FPG)
Time frame: From baseline (week 1) to week 16
Change in HbA1c (glycated haemoglobin)
Time frame: From baseline (week 1) to week 16
Change in fasting insulin
Time frame: From baseline (week 1) to week 16
Change in HOMA-IR
Time frame: From baseline (week 1) to week 16
Blood pressure (systolic and diastolic)
Time frame: From baseline (week 1) to week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 13 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: finished, as of the sponsor's last update on 28 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage change in body weight (time frame: From baseline (week1) to week16). 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 28 May 2026.