A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes

NCT07755150 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-CP-DA168-08
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study aims to assess the efficacy, safety, and PK characteristics of DA-302168S tablets in Chinese T2DM participants, and to provide dose-selection evidence for the Phase III confirmatory trial.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c

  measured in %

  From baseline (week 1) to week 16

Secondary Outcomes (6)

• Percentage of participants with HbA1c <7.0% and ≤6.5%

  From baseline (week 1) to week 16

• Other parameters related to glucose metabolism

  From baseline (week 1) to week 16

• Change from baseline in fasting lipid profile

  From baseline (week 1) to week 16

• Change from baseline in systolic and diastolic blood pressure

  From baseline (week 1) to week 16

• Percent and absolute changes from baseline in body weight

  From baseline (week 1) to week 16

Study Arms (2)

DA-302168S

EXPERIMENTAL

Cohort 1-5mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Cohort 2-10mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Cohort 3-15mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Cohort 4-20mg dose group：Participants will receive DA-302168S tablets once daily orally, 16weeks. Cohort 5-20mg dose group：Participants will receive DA-302168S tablets once daily orally, 10weeks.

Drug: DA-302168S

Placebo of DA-302168S

PLACEBO COMPARATOR

Cohort 1-5mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. Cohort 2-10mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. Cohort 3-15mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks. Cohort 4-20mg dose group：Participants will receive matching placebo tablets orally once daily for 16 weeks.

Drug: Placebo of DA-302168S

Interventions

DA-302168S DRUG

A small molecule GLP-1R agonist tablet, orally administration, once daily，16weeks.

DA-302168S

Placebo of DA-302168S DRUG

Matching placebo tablet will be provided

Placebo of DA-302168S

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 to 75 years (inclusive), both sexes.
• Diagnosed with T2DM according to the Chinese Diabetes Prevention and Treatment Guidelines (2024 Edition) for at least 3 months at screening, and meeting one of the following: (1) on stable metformin monotherapy for ≥8 weeks prior to screening, with a daily dose of ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day, in addition to diet and exercise; stable treatment defined as no change in daily dose; (2) glycemic control by diet and exercise alone for ≥8 weeks prior to screening.
• HbA1c (local laboratory) ≥7.5% and ≤11.0% at screening; and HbA1c (central laboratory) ≥7.5% and ≤10.5% at randomization.
• BMI 22.5-40 kg/m² (inclusive), and stable body weight for 3 months prior to screening (weight change \<5%, calculated as \[max weight - min weight\] / max weight × 100%).

You may not qualify if:

• History of type 1 diabetes, diabetes due to pancreatic injury, or other types of diabetes (excluding gestational diabetes) other than T2DM.
• Acute diabetic complications (e.g., diabetic ketoacidosis, lactic acidosis, or hyperosmolar nonketotic coma) within 6 months prior to ICF signing; history of grade 3 hypoglycemia within 6 months prior to ICF signing, or ≥3 episodes of hypoglycemia (blood glucose \<3.9 mmol/L) from 1 month before screening to randomization.
• Clinically significant active infection or other diseases (including but not limited to neurological, psychiatric, cardiovascular, endocrine, digestive, respiratory, urinary, hematological, or immunological disorders, except those related to T2DM) within 6 months prior to screening that, in the investigator's judgment, may interfere with trial results or pose additional risks with study drug administration.
• Endocrine diseases or history that may significantly affect body weight (e.g., Cushing's syndrome, obesity due to pituitary or hypothalamic disorders), or obesity due to monogenic mutations or genetic obesity syndromes.
• Evidence of significant active autoimmune abnormalities (e.g., lupus or rheumatoid arthritis) requiring systemic glucocorticoid therapy during the trial, as judged by the investigator.
• Severe chronic diabetic complications at screening (e.g., proliferative retinopathy or maculopathy, painful diabetic neuropathy, intermittent claudication, or diabetic foot).
• History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2.
• Hyperthyroidism (including clinical and subclinical) at screening, or hypothyroidism not controlled with stable medication dose (defined as stable dose for ≥3 months with normal thyroid function tests) based on local laboratory reference ranges.
• History of acute pancreatitis, or prior chronic pancreatitis or pancreatic injury, or other high-risk factors for pancreatitis.
• Acute cholecystitis within 3 months prior to ICF signing, or presence of cholecystitis/cholangitis/bile duct stones/multiple gallstones at screening, or gallbladder-related conditions at screening that, in the investigator's judgment, may predispose to cholecystitis (except those who have undergone cholecystectomy and are deemed eligible by the investigator).
• Dysphagia or history of gastrointestinal disorders affecting drug absorption, including but not limited to gastrectomy or resection of any intestinal segment, severe gastrointestinal disease, or clinically evident gastric emptying abnormalities.
• Uncontrolled or unstable hypertension at screening, defined as SBP ≥160 mmHg and/or DBP ≥100 mmHg despite regular antihypertensive treatment, or evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension).
• Clinically significant cardiovascular or cerebrovascular diseases, including but not limited to the following events within 6 months prior to ICF signing or during the run-in period: a. unstable angina; b. heart failure (NYHA class III or IV); c. myocardial infarction; d. coronary artery bypass grafting or percutaneous coronary intervention; e. uncontrolled severe arrhythmias, such as sick sinus syndrome, second- or third-degree atrioventricular block; f. cerebrovascular accidents, such as cerebral infarction or transient ischemic attack.
• Hemoglobinopathies or anemia, such as hemolytic anemia or sickle cell anemia.
• History of moderate or severe depression, or PHQ-9 score ≥15 at screening (see Appendix 2), or psychiatric disorders that, in the investigator's opinion, may affect participation.

Sponsors & Collaborators

• Chendu DIAO Pharmaceutical Group CO., LTD.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

xiaolong qin

CONTACT

+8618781997925; qinxiaolong.cn@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): October 20, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)