T2DM (Type 2 Diabetes Mellitus)Phase 2NCT07796477
A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin
A Phase 2 study testing SYH2069 Injection (group 1), SYH2069 Injection (group 2) and SYH2069 Injection (group 3) in people with T2DM (Type 2 Diabetes Mellitus), run by CSPC Ouyi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- SYH2069 Injection (group 1), SYH2069 Injection (group 2) and SYH2069 Injection (group 3)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2026to 19 Oct 2027
- Phase
- Phase 2
- 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
- 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.
Who cannot join
- 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.
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- 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.
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
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Tao Yang, 86-025-68306983, yangtao1969@yeah.net
About this study
Official title: 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
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
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- SYH2069 Injection (group 1), SYH2069 Injection (group 2), SYH2069 Injection (group 3), SYH2069 Injection (group 4), SYH2069 Injection placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2069 Injection (group 1)Drug
administered subcutaneously (SC), Once-Weekly (QW), 28 weeks
SYH2069 Injection (group 2)Drug
administered SC, QW, 28 weeks
SYH2069 Injection (group 3)Drug
administered SC, QW, 28 weeks
SYH2069 Injection (group 4)Drug
administered SC, QW, 28 weeks
SYH2069 Injection placeboDrug
administered SC, QW, 28 weeks
Tirzepatide Injection 15mgDrug
administered SC, QW, 28 weeks
| Study group | Role | What they receive |
|---|---|---|
| SYH2069 Injection (group 1) | Experimental | Participants received SYH2069 Injection dose 1 subcutaneously for 28 weeks Receives: Drug: SYH2069 Injection (group 1) |
| SYH2069 Injection (group2) | Experimental | Participants received SYH2069 Injection dose 2 subcutaneously for 28 weeks Receives: Drug: SYH2069 Injection (group 2) |
| SYH2069 Injection (group 3) | Experimental | Participants received SYH2069 Injection dose 3 subcutaneously for 28 weeks Receives: Drug: SYH2069 Injection (group 3) |
| SYH2069 Injection (group 4) | Experimental | Participants received SYH2069 Injection dose 4 subcutaneously for 28 weeks Receives: Drug: SYH2069 Injection (group 4) |
| SYH2069 Injection placebo | Placebo comparator | Participants received SYH2069 Injection placebo subcutaneously for 28 weeks Receives: Drug: SYH2069 Injection placebo |
| Tirzepatide Injection 15mg | Active comparator | Participants received Tirzepatide Injection 15mg subcutaneously for 28 weeks Receives: Drug: Tirzepatide Injection 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline，Week 28
Secondary outcomes (11)
The percentage of participants reaching the HbA1c target of<7.0% and≤6.5%
Measured: Baseline，Week 28
Change from Baseline in Fasting Plasma Glucose (FPG)
Measured: Baseline，Week 28
Change from baseline in 2-hour postprandial plasma glucose (2h-PPG)
Measured: 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)
Measured: Baseline，Week 28
Change from body weight
Measured: Baseline，Week 28
Change from waist circumference
Measured: Baseline，Week 28
Change from hip circumference
Measured: Baseline，Week 28
Change from waist-to-hip ratio
Measured: Baseline，Week 28
Change from Baseline in blood lipids
Measured: Baseline，Week 28
Change from Baseline in blood pressure [Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)]
Measured: Baseline，Week 28
Change from Baseline in Urinary Albumin to Creatinine Ratio (UACR)
Measured: Baseline，Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start6 Nov 2026 (estimated)
- Primary completion28 Sep 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 T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Model description
- A multi-center, randomized, double-blind, placebo-and active- parallel controlled Phase 2 clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796477
- Sponsor's protocol ID
- SYH2069-003
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07796477
- Acronym / sponsor ID
- SYH2069-003
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 19 Oct 2027 (estimated)
- First posted
- 1 Sep 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- A multi-center, randomized, double-blind, placebo-and active- parallel controlled Phase 2 clinical study
| Arm | Type | Receives |
|---|---|---|
| SYH2069 Injection (group 1) | Experimental | Drug: SYH2069 Injection (group 1)Participants received SYH2069 Injection dose 1 subcutaneously for 28 weeks |
| SYH2069 Injection (group2) | Experimental | Drug: SYH2069 Injection (group 2)Participants received SYH2069 Injection dose 2 subcutaneously for 28 weeks |
| SYH2069 Injection (group 3) | Experimental | Drug: SYH2069 Injection (group 3)Participants received SYH2069 Injection dose 3 subcutaneously for 28 weeks |
| SYH2069 Injection (group 4) | Experimental | Drug: SYH2069 Injection (group 4)Participants received SYH2069 Injection dose 4 subcutaneously for 28 weeks |
| SYH2069 Injection placebo | Placebo comparator | Drug: SYH2069 Injection placeboParticipants received SYH2069 Injection placebo subcutaneously for 28 weeks |
| Tirzepatide Injection 15mg | Active comparator | Drug: Tirzepatide Injection 15mgParticipants received Tirzepatide Injection 15mg subcutaneously for 28 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| SYH2069 Injection (group 1)administered subcutaneously (SC), Once-Weekly (QW), 28 weeks | Drug | SYH2069 Injection (group 1) |
| SYH2069 Injection (group 2)administered SC, QW, 28 weeks | Drug | SYH2069 Injection (group2) |
| SYH2069 Injection (group 3)administered SC, QW, 28 weeks | Drug | SYH2069 Injection (group 3) |
| SYH2069 Injection (group 4)administered SC, QW, 28 weeks | Drug | SYH2069 Injection (group 4) |
| SYH2069 Injection placeboadministered SC, QW, 28 weeks | Drug | SYH2069 Injection placebo |
| Tirzepatide Injection 15mgadministered SC, QW, 28 weeks | Drug | Tirzepatide Injection 15mg |
Primary outcome
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline，Week 28
11 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
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 1 Sep 2026.
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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 2 study testing SYH2069 Injection (group 1), SYH2069 Injection (group 2) and SYH2069 Injection (group 3) in people with T2DM (Type 2 Diabetes Mellitus), run by CSPC Ouyi Pharmaceutical 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 6 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: opening soon, as of the sponsor's last update on 1 Sep 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?
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?
Contact Clinical Trials Information Group Officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline，Week 28). 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 1 Sep 2026.