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

NCT07796477 | Not Yet Recruiting Phase 2

• 1 other identifier: SYH2069-003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Hemoglobin A1c (HbA1c)

  Baseline，Week 28

Secondary Outcomes (11)

• The percentage of participants reaching the HbA1c target of<7.0% and≤6.5%

  Baseline，Week 28

• Change from Baseline in Fasting Plasma Glucose (FPG)

  Baseline，Week 28

• Change from baseline in 2-hour postprandial plasma glucose (2h-PPG)

  Baseline，Week 28

• Changes from baseline in the mean 7-point glucose profile and mean postprandial glucose increment as measured by Self Monitoring of Blood Glucose (SMBG)

  Baseline，Week 28

• Change from body weight

  Baseline，Week 28

Study Arms (6)

SYH2069 Injection (group 1)

EXPERIMENTAL

Participants received SYH2069 Injection dose 1 subcutaneously for 28 weeks

Drug: SYH2069 Injection (group 1)

SYH2069 Injection (group2)

EXPERIMENTAL

Participants received SYH2069 Injection dose 2 subcutaneously for 28 weeks

Drug: SYH2069 Injection (group 2)

SYH2069 Injection (group 3)

EXPERIMENTAL

Participants received SYH2069 Injection dose 3 subcutaneously for 28 weeks

Drug: SYH2069 Injection (group 3)

SYH2069 Injection (group 4)

EXPERIMENTAL

Participants received SYH2069 Injection dose 4 subcutaneously for 28 weeks

Drug: SYH2069 Injection (group 4)

SYH2069 Injection placebo

PLACEBO COMPARATOR

Participants received SYH2069 Injection placebo subcutaneously for 28 weeks

Drug: SYH2069 Injection placebo

Tirzepatide Injection 15mg

ACTIVE COMPARATOR

Participants received Tirzepatide Injection 15mg subcutaneously for 28 weeks

Drug: Tirzepatide Injection 15mg

Interventions

SYH2069 Injection (group 1) DRUG

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

SYH2069 Injection (group 1)

SYH2069 Injection (group 2) DRUG

administered SC, QW, 28 weeks

SYH2069 Injection (group2)

SYH2069 Injection (group 3) DRUG

administered SC, QW, 28 weeks

SYH2069 Injection (group 3)

SYH2069 Injection (group 4) DRUG

administered SC, QW, 28 weeks

SYH2069 Injection (group 4)

SYH2069 Injection placebo DRUG

administered SC, QW, 28 weeks

SYH2069 Injection placebo

Tirzepatide Injection 15mg DRUG

administered SC, QW, 28 weeks

Tirzepatide Injection 15mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female participants, 18-75 years of age.
• \. Confirmed as T2DM for at least 12 weeks.
• \. Body Mass Index (BMI): 22 kg/m\^2 ≤ BMI ≤ 40 kg/m\^2.
• \. Treated with lifestyle intervention and stable treatment with metformin at least 8 weeks prior to screening.
• \. HbA1c 7.5-10.5% (both inclusive) at screening visit.
• \. Able to understand the protocol, and voluntarily signed informed consent.

You may not qualify if:

• \. Type 1 diabetes or other specific types of diabetes.
• \. Allergy to any active ingredient or any excipient of the investigational product, or presence of severe allergic diseases at screening.
• \. Weight change \>5% within 1 month before screening.
• \. History of a level 3 hypoglycemic episode within 6 months prior to screening.
• \. Acute complications of diabetes occurred within 6 months prior to screening.
• \. History of severe chronic diabetic complications within 6 months prior to screening, or have non-proliferative diabetic retinopathy that requires treatment during the study.
• \. History of acute or chronic pancreatitis.
• \. History of acute cardiovascular and cerebrovascular within 6 months prior to screening.
• \. History of malignancy of any organ system within 5 years prior to screening, excluding cured basal cell carcinoma and carcinoma in situ.
• \. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
• \. History of major surgery or suffered blood loss of more than 400 mL within 3 months prior to screening.
• \. Pregnant or lactating woman.
• \. Other conditions judged by the investigator to be unsuitable for participation in this trial.

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Central Study Contacts

Clinical Trials Information Group Officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Open-label between treatment arms，double-blind within each treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multi-center, randomized, double-blind, placebo-and active- parallel controlled Phase 2 clinical study

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): November 6, 2026
• Primary Completion (Estimated): September 28, 2027
• Study Completion (Estimated): October 19, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Locations

CN (1)