Not yet recruitingNCT07796477Updated Sep 1, 2026

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

A Phase 2 interventional study of SYH2069 Injection (group 1) and SYH2069 Injection (group 2) in T2DM (Type 2 Diabetes Mellitus), sponsored by CSPC Ouyi Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 240
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This study is a multicenter, randomized, double-blind, placebo and active-controlled, dose-finding phase 2 study aimed to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SYH2069 Injection in participants with Type 2 Diabetes Mellitus (T2DM) inadequate glycemic control with diet and exercise alone or metformin monotherapy.

The study consists of four periods: a 2-week screening period, a 3-week run-in period, a 28-week treatment period and a 3-week safety follow-up period.

A total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or >8.5%) and prior metformin use (yes or no) , then randomized 4:1:4:1:4:1:4:1:4 to SYH2069 group 1, SYH2069 group 1 placebo, SYH2069 group 2, SYH2069 group 2 placebo, SYH2069 group 3, SYH2069 group 3 placebo, SYH2069 group 4, SYH2069 group 4 placebo and Tirzepatide injection 15mg, with 40 participants in each SYH2069 or Tirzepatide group and 10 participants in each SYH2069 placebo group. All treatment groups will implement dose titration to achieve the target dose.

Conditions studied

T2DM (Type 2 Diabetes Mellitus)

Browse trials for

Diabetes Mellitus, Type 2 9,339

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 240 participants (estimated)

Study arms

Experimental
SYH2069 Injection (group 1)
Participants received SYH2069 Injection dose 1 subcutaneously for 28 weeks
Drug: SYH2069 Injection (group 1)
Experimental
SYH2069 Injection (group2)
Participants received SYH2069 Injection dose 2 subcutaneously for 28 weeks
Drug: SYH2069 Injection (group 2)
Experimental
SYH2069 Injection (group 3)
Participants received SYH2069 Injection dose 3 subcutaneously for 28 weeks
Drug: SYH2069 Injection (group 3)
Experimental
SYH2069 Injection (group 4)
Participants received SYH2069 Injection dose 4 subcutaneously for 28 weeks
Drug: SYH2069 Injection (group 4)
Placebo comparator
SYH2069 Injection placebo
Participants received SYH2069 Injection placebo subcutaneously for 28 weeks
Drug: SYH2069 Injection placebo
Active comparator
Tirzepatide Injection 15mg
Participants received Tirzepatide Injection 15mg subcutaneously for 28 weeks
Drug: Tirzepatide Injection 15mg

Interventions

DrugSYH2069 Injection (group 1)
administered subcutaneously (SC), Once-Weekly (QW), 28 weeks
DrugSYH2069 Injection (group 2)
administered SC, QW, 28 weeks
DrugSYH2069 Injection (group 3)
administered SC, QW, 28 weeks
DrugSYH2069 Injection (group 4)
administered SC, QW, 28 weeks
DrugSYH2069 Injection placebo
administered SC, QW, 28 weeks
DrugTirzepatide Injection 15mg
administered SC, QW, 28 weeks

What researchers measure

Primary outcomes

Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline，Week 28

Secondary outcomes

The percentage of participants reaching the HbA1c target of<7.0% and≤6.5%
Time frame: Baseline，Week 28
Change from Baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline，Week 28
Change from baseline in 2-hour postprandial plasma glucose (2h-PPG)
Time frame: Baseline，Week 28
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
Change from body weight
Time frame: Baseline，Week 28
Change from waist circumference
Time frame: Baseline，Week 28
Change from hip circumference
Time frame: Baseline，Week 28
Change from waist-to-hip ratio
Time frame: Baseline，Week 28
Change from Baseline in blood lipids
Time frame: Baseline，Week 28
Change from Baseline in blood pressure [Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)]
Time frame: Baseline，Week 28
Change from Baseline in Urinary Albumin to Creatinine Ratio (UACR)
Time frame: Baseline，Week 28

Study locations

1 site

Jiangsu Province Hospital
Nanjing, Jiangsu 210029, China
- Tao Yang · Contact · yangtao1969@yeah.net · 86-025-68306983

Registry details

Key details

Study ID: NCT07796477
Lead sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Sep 1, 2026
Start date: Nov 6, 2026 (estimated)
Primary completion: Sep 28, 2027 (estimated)
Completion: Oct 19, 2027 (estimated)
Last update: Sep 1, 2026

Study contacts

Clinical Trials Information Group Officer

Contact

ctr-contact@cspc.cn

86-0311-69085587

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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