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

NCT06257966 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing whether the experimental drug JY09, when combined with metformin, is as effective as the approved drug dulaglutide in lowering blood sugar levels in adults with type 2 diabetes.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 600 people

Who can join Ages 18–75 · all sexes

Timeline Started 2024-07 · est. completion 2026-11

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06257966 ↗

Description as written by the study sponsor.

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)

Treatments tested

Exendin-4 Fc fusion protein injection(1.2mg） also known as JY09(1.2mg) Drug

1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.
Exendin-4 Fc fusion protein injection（2.4mg） also known as JY09(2.4mg) Drug

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.
Dulaglutide Drug

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

Metformin hydrochloride tablets, oral administration, 54 weeks of treatment

Main thing measured	HbA1c
Sponsor	Beijing Dongfang Biotech Co., Ltd.
Conditions studied	Type2 Diabetes Mellitus
GLP-1 drugs	dulaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06257966 ↗