Not yet recruitingPhase 2

A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin

A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of SYH2069 Injection in Participants With Type 2 Diabetes Mellitus With Inadquate Glycemic Control After Diet and Exercise Alone or Metformin Monotherapy

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Assets

SYH2069 / Tirzepatide

Listed sites

Recruiting sites

Estimated enrollment

240

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≤40•HbA1c 7.5-10.5%

Primary endpoint

•Hemoglobin A1c (HbA1c)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07796477

Org study IDSYH2069-003

Timeline

Milestones

Study first posted2026-09-01actual

Last update posted2026-09-01actual

Study start2026-11-06estimated

Primary completion2027-09-28estimated

Study completion2027-10-19estimated

Assets

Investigational agents

SYH2069 Tirzepatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•1. Male or female participants, 18-75 years of age.

•2. Confirmed as T2DM for at least 12 weeks.

•3. Body Mass Index (BMI): 22 kg/m^2 ≤ BMI ≤ 40 kg/m^2.

•4. Treated with lifestyle intervention and stable treatment with metformin at least 8 weeks prior to screening.

•5. HbA1c 7.5-10.5% (both inclusive) at screening visit.

•6. Able to understand the protocol, and voluntarily signed informed consent.

Exclusion criteria

•1. Type 1 diabetes or other specific types of diabetes.

•2. Allergy to any active ingredient or any excipient of the investigational product, or presence of severe allergic diseases at screening.

•3. Weight change >5% within 1 month before screening.

•4. History of a level 3 hypoglycemic episode within 6 months prior to screening.

•5. Acute complications of diabetes occurred within 6 months prior to screening.

•6. History of severe chronic diabetic complications within 6 months prior to screening, or have non-proliferative diabetic retinopathy that requires treatment during the study.

•7. History of acute or chronic pancreatitis.

•8. History of acute cardiovascular and cerebrovascular within 6 months prior to screening.

•9. History of malignancy of any organ system within 5 years prior to screening, excluding cured basal cell carcinoma and carcinoma in situ.

•10. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).

•11. History of major surgery or suffered blood loss of more than 400 mL within 3 months prior to screening.

•12. Pregnant or lactating woman.

•13. Other conditions judged by the investigator to be unsuitable for participation in this trial.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Renal / kidney

Other (unclassified)

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change from body weight

Time frame:Baseline，Week 28

descriptive

Secondary/protocol endpoint

Change from waist circumference

Time frame:Baseline，Week 28

descriptive

Secondary/protocol endpoint

Change from waist-to-hip ratio

Time frame:Baseline，Week 28

ratio, improvement

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

Change from baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline，Week 28

change from baseline, improvement

Secondary/protocol endpoint

The percentage of participants reaching the HbA1c target of<7.0% and≤6.5%

Time frame:Baseline，Week 28

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline，Week 28

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in 2-hour postprandial plasma glucose (2h-PPG)

Time frame:Baseline，Week 28

change from baseline, improvement

Secondary/protocol endpoint

Changes from baseline in the mean 7-point glucose profile and mean postprandial glucose increment as measured by Self Monitoring of Blood Glucose (SMBG)

Time frame:Baseline，Week 28

descriptive

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Urinary Albumin to Creatinine Ratio (UACR)

Time frame:Baseline，Week 28

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change from Baseline in blood lipids

Time frame:Baseline，Week 28

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in blood pressure [Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)]

Time frame:Baseline，Week 28

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from hip circumference

Time frame:Baseline，Week 28

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.