Diabetes (DM)Phase 3NCT07308184
Bridge Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Patients With T2DM Inadequately Controlled by Diet and Exercise Alone
A Phase 3 study testing IN-B00009 in people with Diabetes (DM) and Diabetes Mellitus Type 2, run by HK inno.N Corporation.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Diabetes (DM), Diabetes Mellitus Type 2
- What is being tested?
- IN-B00009
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
- Subjects with a history of uncontrolled respiratory disease (chronic obstructive pulmonary disease, bronchial asthma, active tuberculosis, etc.) within 24 weeks prior to the screening visit
- Subjects who have had severe gastrointestinal disease (active ulcer, etc.), gastrointestinal surgery, or clinically significant abnormal gastric emptying, or those who have chronically used medications that directly affect gastrointestinal motility within 24 weeks prior to the screening visit (However, those with a history of appendectomy or cholecystectomy are eligible to participate)
- Subjects with a history of acute or chronic pancreatitis (e.g., acute and chronic pancreatitis, symptomatic cholecystitis, pancreatic injury, etc.)
- Subjects with a history of malignant tumor within the past 5 years
- Those who have been assessed as having achieved complete remission (CR, pCR) of the tumor and have remained free of recurrence for ≥5 years from the date of assessment are eligible to participate
- Those with a history of thyroid cancer, excluding medullary thyroid carcinoma (MTC), carcinoma in situ of cervix, or basal cell or squamous cell carcinoma within the past 5 years are eligible to participate
- Subjects with a history of major depressive disorder, anxiety disorder, or other severe mental illness (e.g., schizophrenia, bipolar disorder, etc.) in an unstable state
- Subjects who tested positive for HBsAg, HCV antibody, or HIV antibody at the screening visit (However, those who tested positive for HCV-Ab but negative for HCV-RNA may participate.)
- Subjects whose test results meet the following at the screening visit and pre-randomization testing:
- Uncontrolled hypertension: siSBP≥160 mmHg or siDBP≥100 mmHg
- AST or ALT > 3 times the upper limit of normal , total bilirubin > 2 times the upper limit of normal
- Amylase or Lipase > 3 times the upper limit of normal
- eGFR ≤ 45mL/min/1.73m²
- TG > 500 mg/dL (or 5.65 mmol/L)
- Fasting C-peptide < 0.6 ng/mL (or 0.2 nmol/L)
- Hemoglobin <11.0 g/dL (male), <10.0 g/dL (female)
- Calcitonin ≥ 100 ng/L (or 100 pg/mL)
- Subjects with hematologic conditions (e.g., hemolytic anemia, hemoglobinopathies) that may interfere with HbA1c measurements at the screening visit and pre-randomization testing
- Subjects with a history of alcoholism or substance abuse
- Subjects who have taken systemic steroids or growth hormones for 7 days or more (including oral and intravenous administration) within 8 weeks prior to the screening visit
- Subjects with a history of resistance or hypersensitivity to the drugs in the same class as the investigational product
- Subjects who have received other investigational products or used investigational devices within 12 weeks prior to the screening visit
- Subjects who have donated blood, had significant bleeding (>400 mL), or received blood transfusion or blood products within 12 weeks prior to the screening visit
- Subjects with a history of nonarteritic anterior ischemic optic neuropathy (NAION)
- Subjects with a positive pregnancy test, pregnant women, or lactating women
- Subjects who deemed ineligible as subjects by the investigator for other reasons
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
Read the 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
- Being tested
- IN-B00009, Placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-B00009Drug
Test drug
PlaceboDrug
Placebo drug
| Study group | Role | What they receive |
|---|---|---|
| IN-B00009 | Experimental | Not described Receives: Drug: IN-B00009 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in HbA1c from baseline at Week 24
Measured: Baseline, 24 Weeks
Secondary outcomes (9)
A change in HbA1c from baseline at each time point at Weeks 4, 8, 12, and 16
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Proportion of subjects with HbA1c <7% at week 24
Measured: 24 weeks
Proportion of subjects with HbA1c ≤6.5% at week 24
Measured: 24 weeks
A change in glucose metabolism indicators from baseline at week 24
FPG, fasting insulin, HOMA-IR, HOMA-β (However, percent changes in fasting insulin, HOMA-IR, and HOMA-β are also presented)
Measured: Baseline, 24 weeks
A percent change in lipids from baseline at week 24
TG, LDL-C, HDL-C
Measured: Baseline, 24 weeks
A change in blood pressure from baseline at week 24
sitSBP, sitDBP
Measured: Baseline, 24 weeks
A change in body weight from baseline at week 24
Measured: Baseline, 24 weeks
A percent change in body weight from baseline at week 24
Measured: Baseline, 24 weeks
A change in waist circumference from baseline at week 24
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Rae Kim, Principal investigator, Bucheon St. Mary Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308184
- Sponsor's protocol ID
- IN_ECN_302
- Status last verified
- Nov 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07308184
- Acronym / sponsor ID
- IN_ECN_302
- Conditions
- Diabetes (DM), Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN-B00009 | Experimental | Drug: IN-B00009 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Subjects with HbA1c levels of 7.5% to 11.0% at the screening visit and 7.0% to 10.5% before randomization
Key exclusion criteria (41 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN-B00009Test drug | Drug | IN-B00009 |
| PlaceboPlacebo drug | Drug | Placebo |
Primary outcome
A change in HbA1c from baseline at Week 24
Time frame: Baseline, 24 Weeks
9 secondary outcomes
A change in HbA1c from baseline at each time point at Weeks 4, 8, 12, and 16
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Proportion of subjects with HbA1c <7% at week 24
Time frame: 24 weeks
Proportion of subjects with HbA1c ≤6.5% at week 24
Time frame: 24 weeks
A change in glucose metabolism indicators from baseline at week 24
Time frame: Baseline, 24 weeks
A percent change in lipids from baseline at week 24
Time frame: Baseline, 24 weeks
A change in blood pressure from baseline at week 24
Time frame: Baseline, 24 weeks
A change in body weight from baseline at week 24
Time frame: Baseline, 24 weeks
A percent change in body weight from baseline at week 24
Time frame: Baseline, 24 weeks
A change in waist circumference from baseline at week 24
Time frame: Baseline, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sung-Rae Kim principal investigator
Bucheon St. Mary Hospital, The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IN-B00009 in people with Diabetes (DM) and Diabetes Mellitus Type 2, run by HK inno.N Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonghoon Kim (031-5176-4663, jonghoon.kim@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in HbA1c from baseline at Week 24 (time frame: Baseline, 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.