NCT06254014

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

A Phase 3, Multi-center, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of JY09 in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Beijing Dongfang Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study was designed as a multicenter, randomized, double-blind, placebo-parallel controlled Phase III clinical study to evaluate the efficacy and safety of Exendin-4Fc fusion protein (JY09) injection in adult subjects with type 2 diabetes mellitus (T2DM) who have poor glycemic control after dietary exercise intervention only. The proposed plan is to enroll 270 subjects with T2DM, using stratified block group randomization, with the stratification factor being baseline HbA1c (≤8.5% or \>8.5%), and randomly assign them to the 1.2 mg JY09 injection group (n=90 subjects), the 2.4 mg JY09 injection group (n=90 subjects), and the placebo group (n=90 subjects) in a 1:1:1 ratio. The trial was divided into 4 phases, i.e., a screening period of 2 weeks, a single-blind introduction period of 4 weeks, a treatment period of 54 weeks (26 weeks for the core treatment period and 28 weeks for the extended treatment period), and a safety follow-up period of 4 weeks. Total 64 weeks.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Exendin-4 Fc fusion protein injection	1.2mg, subcutaneous injection in the abdomen, biweekly, 54 weeks of treatment.
DRUG	Exendin-4 Fc fusion protein injection	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	Placebo	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).

Timeline

• Start date: 2024-07-10
• Primary completion: 2026-05-01
• Completion: 2026-06-30
• First posted: 2024-02-12
• Last updated: 2025-09-18

Locations

1 site across 1 country: China