NCT06257966View on ClinicalTrials.gov

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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

July 17, 2024

Primary Completion Date

October 1, 2026

Study Completion Date

November 30, 2026

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

Trial Locations (1)

100034

Peking University First Hospital, Beijing

All Listed Sponsors
lead

Beijing Dongfang Biotech Co., Ltd.

INDUSTRY

NCT06257966 - A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Dulaglutide in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin | Biotech Hunter | Biotech Hunter