A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM Patients

NCT06254014 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing whether the medication JY09 lowers blood sugar levels in adults with type 2 diabetes compared to a placebo.

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, quadruple-blind treatment study

Participants 270 people

Who can join Ages 18–75 · all sexes

Timeline Started 2024-07 · est. completion 2026-06

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06254014 ↗

Description as written by the study sponsor.

The main purpose of this study is to investigate the efficacy and safety of JY09 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone

Treatments tested

Exendin-4 Fc fusion protein injection 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 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.
Placebo also known as Injection mimetic Drug

0.6 ml, placebo injection, biweekly subcutaneous abdominal injections for 26 weeks (core treatment period), after which placebo was randomized 1:1 to JY09 (1.2 mg) and JY09 (2.4 mg) continued subcutaneous abdominal injections biweekly for 28 weeks (extended treatment period).

Main thing measured	HbA1c
Sponsor	Beijing Dongfang Biotech Co., Ltd.
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06254014 ↗