A Multi-center, Randomized, Double-Blind, Placebo Controlled, Parallel, Phase 3 Bridge Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone

NCT07308184 Phase 3 NOT_YET_RECRUITING

This Phase 3 Bridge study is designed to evaluate the efficacy and safety of IN-B00009 Injection in Patients with T2DM Inadequately Controlled by Diet and Exercise Alone

Details

Lead sponsor	HK inno.N Corporation
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	110
Start date	2025-12
Completion	2027-09

Conditions

• Diabetes (DM)
• Diabetes Mellitus Type 2

Interventions

• IN-B00009
• Placebo

Primary outcomes

• A change in HbA1c from baseline at Week 24 — Baseline, 24 Weeks