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

NCT07796477 · tracked via the Priya Life Science China tracker

Sponsor

CSPC Ouyi Pharmaceutical Co., Ltd

Phase

Phase 2

Started

2026-11-06

Last updated

2026-09-01

Condition(s) studied

T2DM (Type 2 Diabetes Mellitus)

Investigational drug(s) / intervention(s)

SYH2069 Injection (group 1) →SYH2069 Injection (group 2) →SYH2069 Injection (group 3) →SYH2069 Injection (group 4) →SYH2069 Injection placeboTirzepatide Injection 15mg →

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

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * 1\. Male or female participants, 18-75 years of age. * 2\. Confirmed as T2DM for at least 12 weeks. * 3\. Body Mass Index (BMI): 22 kg/m\^2 ≤ BMI ≤ 40 kg/m\^2. * 4\. Treated with lifestyle intervention and stable treatment with metformin at least 8 weeks prior to screening. * 5\. HbA1c 7.5-10.5% (both inclusive) at screening visit. * 6\. Able to understand the protocol, and voluntarily signed informed consent. Exclusion Criteria: * 1\. Type 1 diabetes or other specific types of diabetes. * 2\. Allergy to any active ingredient or any excipient of the investigational product, or presence of severe allergic diseases at screening. * 3\. Weight change \>5% within 1 month before screening. * 4\. History of a level 3 hypoglycemic episode within 6 months prior to screening. * 5\. Acute complications of diabetes occurred within 6 months prior to screening. * 6\. History of severe chronic diabetic complications within 6 months prior to screening, or have non-proliferative diabetic retinopathy that requires treatment during the study. * 7\. History of acute or chronic pancreatitis. * 8\. History of acute cardiovascular and cerebrovascular within 6 months prior to screening. * 9\. History of malignancy of any organ system within 5 years prior to screening, excluding cured basal cell carcinoma and carcinoma in situ. * 10\. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2). * 11\. History of major surgery or suffered blood loss of more than 400 mL within 3 months prior to screening. * 12\. Pregnant or lactating woman. * 13\. Other conditions judged by the investigator to be unsuitable for participation in this trial.

Primary outcome measure(s)

Change from baseline in Hemoglobin A1c (HbA1c) — Baseline，Week 28

Trial sites (1)

Facility	City	Region	Status
Jiangsu Province Hospital	Nanjing	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07796477 on ClinicalTrials.gov ↗ ← All trials in China