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

NCT07796477 · Not yet recruiting

Last updated 2026-09-22

This clinical trial is testing the safety and effects of the investigational drug SYH2069 injection in adults with type 2 diabetes whose blood sugar is not well-controlled by diet, exercise, or metformin alone.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 240 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2026-11 · est. completion 2027-10

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT07796477 ↗

Description as written by the study sponsor.

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.

Treatments tested

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

Main thing measured	Change from baseline in Hemoglobin A1c (HbA1c)
Sponsor	CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions studied	T2DM (Type 2 Diabetes Mellitus)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07796477 ↗