MedTrace Logo

A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

NCT06257966 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-09-17

No results posted yet for this study

Summary

The aim of the study is to compare the efficacy and safety of two JY09 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)

Conditions

  • Type2 Diabetes Mellitus

Interventions

DRUG

Exendin-4 Fc fusion protein injection(1.2mg）

1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.

DRUG

Exendin-4 Fc fusion protein injection（2.4mg）

The first dose of 1.2 mg was administered subcutaneously in the abdomen, and after two weeks, the dose was adjusted to 2.4 mg, followed by a continuation of treatment for 52 weeks.

DRUG

Dulaglutide

1.5 mg dulaglutide injection subcutaneously once a week for 54 weeks.

DRUG

Metformin

Metformin hydrochloride tablets, oral administration, 54 weeks of treatment

Sponsors & Collaborators

  • Beijing Dongfang Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junqing Zhang, Doctor · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2026-10-01
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06257966 on ClinicalTrials.gov