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

NCT06254014 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-09-18

No results posted yet for this study

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

Conditions

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).

Sponsors & Collaborators

  • Beijing Dongfang Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Linong Ji, Doctor · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2026-05-01
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06254014 on ClinicalTrials.gov