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