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

NCT07796477 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-09-01

No results posted yet for this study

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.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Interventions

DRUG

SYH2069 Injection (group 1)

administered subcutaneously (SC), Once-Weekly (QW), 28 weeks

DRUG

SYH2069 Injection (group 2)

administered SC, QW, 28 weeks

DRUG

SYH2069 Injection (group 3)

administered SC, QW, 28 weeks

DRUG

SYH2069 Injection (group 4)

administered SC, QW, 28 weeks

DRUG

SYH2069 Injection placebo

administered SC, QW, 28 weeks

DRUG

Tirzepatide Injection 15mg

administered SC, QW, 28 weeks

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-06
Primary Completion
2027-09-28
Completion
2027-10-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07796477 on ClinicalTrials.gov