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JY09 in type 2 diabetes inadequately controlled by diet and exercise
NCT06254014Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Jul 2024
- Primary completion
- May 2026
- Countries
- 1
- Modality
- Fc-Fusion Proteins
- Drugs
- JY-09
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 3, randomised, double-blind trial of JY-09 in type 2 diabetes mellitus (T2DM) (3 arms), sponsored by Beijing Dongfang Biotech Co., Ltd. Primary endpoint: Glycated Hemoglobin at 26 weeks. Started Jul 2024; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
JY09 1.2mg
1.2mg JY09 subcutaneous injection biweekly for 54 weeks
JY09 2.4mg
1.2mg initial dose for 2 weeks, then 2.4mg JY09 subcutaneous injection biweekly for 52 weeks
Placebo → JY09
Placebo for 26 weeks, then crossover to JY09 (1.2mg or 2.4mg) for 28 weeks
03
Who it enrols
Adults aged 18-75 with type 2 diabetes for ≥12 weeks, HbA1c 7.0-10.5%, BMI 18.5-35.0 kg/m², inadequately controlled by diet and exercise alone for ≥8 weeks, no antidiabetic medications in prior 8 weeks
04
Endpoints
Primary
Glycated Hemoglobin
Secondary
Proportion of patients achieving HbA1c <6.5%
Proportion of patients achieving HbA1c <7%
Glycated Hemoglobin
Fasting Plasma Glucose
Fasting Insulin
Homeostatic Model Assessment of Insulin Resistance
Health Survey Short Form
Blood Pressure
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