NCT07308184

Bridge Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a double-blind, randomized, placebo-controlled, Parallel, Phase 3 Bridge study. If the subjects are ultimately determined to meet all inclusion/exclusion criteria based on the results of the pre-randomization testing conducted at Visit 3, they are stratified based on HbA1c (≤ 8.5%, \> 8.5%) and randomly assigned to either the study group or the placebo group in a 1:1 ratio at Visit 4. Subjects will receive the investigational product once weekly for up to 24 weeks. During the 24-week treatment period, the study group will begin with IN-B00009 injection at an initial dose of 0.3 mg and increase the dose at 4-week intervals to reach a target dose of 1.2 mg. After reaching the target dose, the dose will be maintained. The placebo group will receive the same volume of placebo as the study group at each time point. \* Duration of Administration / Study Group / Placebo Group 4 weeks(week 0 \~ week 3) / IN-B00009 inj. 0.3 mg / Placebo 0.15 mL 4 weeks(week 4 \~ week 7) / IN-B00009 inj. 0.6 mg / Placebo 0.3 mL 16 weeks(week 8 \~ week 23) / IN-B00009 inj. 1.2 mg / Placebo 0.6 mL

Conditions

• Diabetes (DM)
• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
DRUG	IN-B00009	Test drug
DRUG	Placebo	Placebo drug

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-08-01
• Completion: 2027-09-01
• First posted: 2025-12-29
• Last updated: 2025-12-29