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

NCT07308184 | Not Yet Recruiting Phase 3

• 1 other identifier: IN_ECN_302
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Diabetes (DM); Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• A change in HbA1c from baseline at Week 24

  Baseline, 24 Weeks

Secondary Outcomes (9)

• A change in HbA1c from baseline at each time point at Weeks 4, 8, 12, and 16

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

• Proportion of subjects with HbA1c <7% at week 24

  24 weeks

• Proportion of subjects with HbA1c ≤6.5% at week 24

  24 weeks

• A change in glucose metabolism indicators from baseline at week 24

  Baseline, 24 weeks

• A percent change in lipids from baseline at week 24

  Baseline, 24 weeks

Study Arms (2)

IN-B00009

EXPERIMENTAL

Drug: IN-B00009

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IN-B00009 DRUG

Test drug

IN-B00009

Placebo DRUG

Placebo drug

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 19 to 75 years at the time of written consent
• Subjects with a BMI ≥ 20 kg/m² and ≤ 35 kg/m² at the screening visit
• ☞BMI (kg/m²) = Weight (kg) / Height (m)²
• Among subjects who have been diagnosed with T2DM at least 12 weeks ago and have followed a stable diet and exercise program for at least 8 weeks prior to the screening visit, those who meet any of the following criteria:
• Those who have not administered hypoglycemic agents within the past 12 weeks
• Those who have administered oral hypoglycemic agents within the past 12 weeks, but have not administered them within 5 weeks prior to the screening visit
• Subjects with HbA1c levels of 7.5% to 11.0% at the screening visit and 7.0% to 10.5% before randomization
• Subjects with fasting plasma glucose (FPG) levels ≤ 250 mg/dL (13.9 mmol/L) at the screening visit and pre-randomization testing
• Subjects who are able to self-monitor blood glucose levels and record subject diary cards during the study
• Subjects who agree to use medically acceptable contraceptive methods (including those medically incapable of pregnancy) during the study
• Subjects who are able to understand and follow instructions and participate throughout the study

You may not qualify if:

• Subjects who have been diagnosed with type 1 diabetes mellitus (T1DM) or diabetes due to a genetic defect or exocrine pancreatic dysfunction
• Subjects who have been administered GLP-1 analogues or DPP-4 inhibitors within 12 weeks prior to the screening visit
• Subjects who have used insulin within 24 weeks prior to the screening visit (excluding the short-term use for the treatment of hyperglycemia symptoms within a total of 14 days)
• Subjects with a history of diabetic ketoacidosis, hyperosmolar hyperglycemia, or diabetic lactic acidosis within 24 weeks prior to the screening visit
• Subjects with a history of severe chronic diabetic complications (proliferative diabetic retinopathy or diabetic maculopathy, diabetic peripheral neuropathy, etc.) within 24 weeks prior to the screening visit
• Subjects with a history of level 3 severe hypoglycemia within 24 weeks, or two or more events of level 2 hypoglycemia (blood glucose \< 54 mg/dL) within 4 weeks prior to the screening visit
• Subjects with a history of severe trauma, infection, or surgery that may affect glycemic control within 4 weeks prior to the screening visit
• Subjects with a history of uncontrolled hyperthyroidism or hypothyroidism (However, those with 0.4 uIU/mL ≤ TSH ≤ 6.8 uIU/mL at the screening visit, who have been taking a stable dose of thyroid hormone medication for the past 12 weeks, and whose dose is unlikely to change during the study can participate.)
• Subjects with a history (including family history) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
• Subjects who have received medical or non-medical weight management, including weight management medications or products, within 12 weeks prior to the screening visit, or whose weight percent change confirmed by clinical interview exceeded 5%
• Subjects with at least one of the following medical histories confirmed within 24 weeks prior to the screening visit
• NYHA class III or IV heart failure
• Coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI)
• Ischemic heart disease (acute myocardial infarction, unstable angina, etc.)
• Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), transient ischemic attack (TIA)

Sponsors & Collaborators

• HK inno.N Corporation: lead

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sung-Rae Kim

  Bucheon St. Mary Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonghoon Kim

CONTACT

031-5176-4663; jonghoon.kim@inno-n.com

Yugyeong Park

CONTACT

031-5176-4661; yugyeong.park@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share