Clinical trial
A Study of SYH2069 Injection in Participants With T2DM Not Controlled With Diet/Exercise Alone or Metformin
Opening soon · Phase 2 · 1 countries · Registry ID NCT07796477
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
SYH2069 Injection (group 1)
administered subcutaneously (SC), Once-Weekly (QW), 28 weeks
SYH2069 Injection (group 2)
administered SC, QW, 28 weeks
SYH2069 Injection (group 3)
administered SC, QW, 28 weeks
SYH2069 Injection (group 4)
administered SC, QW, 28 weeks
SYH2069 Injection placebo
administered SC, QW, 28 weeks
Tirzepatide Injection 15mg
administered SC, QW, 28 weeks
Primary outcomes
Study locations
1 locations were listed when this page was built. The first 40 are shown.