Status:
NOT_YET_RECRUITING
Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus
Lead Sponsor:
HK inno.N Corporation
Conditions:
Obesity &Amp; Overweight
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
This Phase 3 study is designed to evaluate the efficacy and safety of IN-B00009 injection in adults with obesity or overweight without diabetes mellitus
Eligibility Criteria
Inclusion
- Aged 19 to 75 years as of the date of written consent
- Those who meet any of the following obesity criteria at the screening visit
- BMI ≥ 30 kg/m2
- 27 kg/m2 ≤ BMI \< 30 kg/m2 with at least one risk factor or comorbidity
- BMI (kg/m2) = weight (kg) / height (m)2
- Hypertension: Taking antihypertensive medication or sitSBP ≥ 140 mmHg or sitDBP ≥ 90 mmHg
- Dyslipidemia: Taking dyslipidemia medication or Total Cholesterol ≥ 240mg/dL or LDL-C ≥ 160 mg/dL or TG ≥ 200 mg/dL or HDL-C \< 40 mg/dL
- Obstructive sleep apnea
- Cardiovascular and cerebrovascular diseases: Ischemic cardiovascular and cerebrovascular diseases not corresponding to exclusion criterion 17, heart failure of NYHA Class I to III, etc.
- Prediabetes: 100 mg/dL ≤ FPG ≤ 125 mg/dL or 140 mg/dL ≤ PG ≤ 199 mg/dL at 2 hours after 75 g oral glucose load or 5.7% ≤ HbA1c ≤ 6.4%
- Self-reported history of at least one failed attempt at weight control using diet and exercise therapy prior to the screening visit
- Able to agree to and follow the reduced-calorie diet and exercise therapy recommended in this study during the study period
- Agrees to use a medically appropriate method of contraception (including medically infertile conditions) during the study period
Exclusion
- Body weight change exceeding 5 kg within 3 months of the screening visit
- Diabetes (Type 1, Type 2, etc.) or HbA1c ≥ 6.5% at the screening visit
- Received any of the following medications or treatments within 3 months of the screening visit
- ① Obesity-related medications (such as GLP-1 receptor agonists) or medications including over-the-counter drugs, herbal medicines, or health functional foods for weight control
- ② Received hypoglycemic agent or requires continuous administration during the study period
- ③ Received systemic steroids for 30 consecutive days or more, or requires continuous administration during the study period
- ④ Received other medications that cause significant body weight changes or requires continuous administration during the study period (e.g.: antipsychotics, tricyclic antidepressants, selective serotonin reuptake inhibitors, noradrenergic and specific serotonergic antidepressant, mood stabilizers (lithium), anticonvulsants, serotonin antagonists, first-generation antihistamines, etc.)
- Diagnosed with obesity due to endocrine disorders (hypothalamic obesity, Cushing's syndrome, insulinoma, adult growth hormone deficiency, hypothyroidism, etc.)
- Diagnosed with obesity due to genetic variations and congenital disorders
- Obesity-causing genes: ob, db, Proopiomelanocortin (POMC), Melanocortin 4 receptor (MC4R) genes, etc.
- Congenital disorders: Prader-Willi syndrome, Laurence-Moon-Biedl syndrome, Alström syndrome, Cohen syndrome, Carpenter syndrome, etc.
- History of bariatric surgery (e.g., adjustable gastric banding, sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion/duodenal switch, etc.) or device procedures, or plans for such during the study period
- However, those who have had devices (e.g., gastric band, intragastric balloon) removed for more than 1 year can participate
- Those who have had liposuction or abdominoplasty for more than 1 year can participate
- Clinically significant gastrointestinal disorders (e.g., gastroparesis, gastric outlet obstruction, peptic ulcer, severe gastroesophageal reflux disease)
- History (including family history) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or results of clinical laboratory test at the screening visit meeting the following:
- Calcitonin ≥ 100 ng/L
- TSH \< 0.6 mIU/L or TSH \> 6.8 mIU/L (However, subjects being treated for hypothyroidism with 0.6 mIU/L ≤ TSH ≤ 6.8 mIU/L, taking stable doses of thyroid hormonal preparation for 3 months prior to the screening visit and unlikely to have dose changes during the study period can participate)
- History of acute or chronic pancreatitis, or results of clinical laboratory test at the screening visit meeting the following:
- \- Amylase or Lipase \> 3 times the upper limit of normal
- Severe hepatic impairment or results of clinical laboratory test at the screening visit meeting the following:
- \- AST or ALT \> 3 times the upper limit of normal or Total bilirubin \> 2 times the upper limit of normal
- Severe renal impairment (eGFR \< 30mL/min/1.73m2)
- Uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg) at the screening visit
- Answered "yes" to question 4 or 5 in the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or history of suicide attempt
- Score of 15 or higher on the Patient Health Questionnaire-9 (PHQ-9) at the screening visit, or history of major depressive disorder with unstable state, anxiety, or other severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) within 2 years
- History of alcohol addiction or drug abuse within 3 months of the screening visit
- History of malignant tumor within the last 5 years
- Those who have been determined as complete remission (CR, pCR) of the tumor and had no relapse for 5 years or more from the date of assessment can participate
- Those with a history of thyroid cancer (excluding MTC), basal cell and squamous cell skin cancer within the last 5 years can participate
- Any of the following medical histories confirmed within 3 months of the screening visit
- Heart failure of NYHA class IV
- Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI)
- Ischemic heart disease (acute myocardial infarction, unstable angina, etc.). However, if the condition has been stable for 6 months or more from the screening visit, participation is possible at the investigator's discretion
- Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), transient ischemic attack (TIA). However, if the condition has been stable for 6 months or more from the screening visit, participation is possible at the investigator's discretion
- History of non-arteritic anterior ischemic optic neuropathy (NAION)
- History of resistance or hypersensitivity to investigational product class drugs (GLP analogues) or history of multi-drug allergies
- Requires administration of contraindicated medications during the study period
- Received other investigational products within 30 days or 5 times the half-life (whichever is longer) if the half-life is known, prior to the screening visit
- Positive for HBsAg, HCV antibody, or HIV antibody at the screening visit
- \- However, those who are HCV-Ab positive but confirmed negative in HCV-RNA test can participate
- Hematological conditions that may interfere with HbA1c measurement (e.g.: hemolytic anemia, hemoglobinopathies)
- Scheduled for surgery requiring hospitalization during the study period or requires surgical treatment
- Positive pregnancy test, pregnant or lactating women
- Considered inappropriate as a study subject by the investigator for other reasons
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07192263
Start Date
September 22 2025
End Date
September 30 2027
Last Update
September 25 2025
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