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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

July 10, 2024

Primary Completion Date

May 1, 2026

Study Completion Date

June 30, 2026

Conditions
Type 2 Diabetes Mellitus
Interventions
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).

Trial Locations (1)

100044

Peking University People's Hospital, Beijing

All Listed Sponsors
lead

Beijing Dongfang Biotech Co., Ltd.

INDUSTRY

NCT06254014 - A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM Patients | Biotech Hunter | Biotech Hunter