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NCT Number: NCT07796477

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 placebo

Drug

administered SC, QW, 28 weeks

Tirzepatide Injection 15mg

Drug

administered SC, QW, 28 weeks

Primary outcomes

  1. Change from baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline,Week 28

Secondary outcomes

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

    Time frame: Baseline,Week 28

  2. Change from Baseline in Fasting Plasma Glucose (FPG)

    Time frame: Baseline,Week 28

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

    Time frame: Baseline,Week 28

  4. 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

  5. Change from body weight

    Time frame: Baseline,Week 28

  6. Change from waist circumference

    Time frame: Baseline,Week 28

  7. Change from hip circumference

    Time frame: Baseline,Week 28

  8. Change from waist-to-hip ratio

    Time frame: Baseline,Week 28

  9. Change from Baseline in blood lipids

    Time frame: Baseline,Week 28

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

    Time frame: Baseline,Week 28

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

    Time frame: Baseline,Week 28

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group Officer

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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