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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
administered subcutaneously (SC), Once-Weekly (QW), 28 weeks
administered SC, QW, 28 weeks
administered SC, QW, 28 weeks
administered SC, QW, 28 weeks
administered SC, QW, 28 weeks
administered SC, QW, 28 weeks
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline,Week 28
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
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