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.
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/m² ≤ BMI ≤ 40 kg/m².
4. Treated with lifestyle intervention and stable treatment with metformin at least 8 weeks prior to screening.
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.
Parallel
SYH2069 Injection (group 1)
Drugadministered subcutaneously (SC), Once-Weekly (QW), 28 weeks
SYH2069 Injection (group 2)
Drugadministered SC, QW, 28 weeks
SYH2069 Injection (group 3)
Drugadministered SC, QW, 28 weeks
SYH2069 Injection (group 4)
Drugadministered SC, QW, 28 weeks
SYH2069 Injection placebo
Drugadministered SC, QW, 28 weeks
Tirzepatide Injection 15mg
Drugadministered SC, QW, 28 weeks
6
Treatment groupsSee each treatment group below.
Change from baseline in Hemoglobin A1c (HbA1c)
The percentage of participants reaching the HbA1c target of<7.0% and≤6.5%
Change from Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in 2-hour postprandial plasma glucose (2h-PPG)
Changes from baseline in the mean 7-point glucose profile and mean postprandial glucose increment as measured by Self Monitoring of Blood Glucose (SMBG)
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