Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus

Exclusion Criteria

• •1. Body weight change exceeding 5 kg within 3 months of the screening visit
• •2. Diabetes (Type 1, Type 2, etc.) or HbA1c ≥ 6.5% at the screening visit
• •3. 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.)
• •4. Diagnosed with obesity due to endocrine disorders (hypothalamic obesity, Cushing's syndrome, insulinoma, adult growth hormone deficiency, hypothyroidism, etc.)
• •5. 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.
• •6. 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
• •7. Clinically significant gastrointestinal disorders (e.g., gastroparesis, gastric outlet obstruction, peptic ulcer, severe gastroesophageal reflux disease)
• •8. 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)
• •9. 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
• •10. 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
• •11. Severe renal impairment (eGFR \< 30mL/min/1.73m2)
• •12. Uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg) at the screening visit
• •13. 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
• •14. 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
• •15. History of alcohol addiction or drug abuse within 3 months of the screening visit
• •16. 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
• •17. 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
• •18. History of non-arteritic anterior ischemic optic neuropathy (NAION)
• •19. History of resistance or hypersensitivity to investigational product class drugs (GLP analogues) or history of multi-drug allergies
• •20. Requires administration of contraindicated medications during the study period
• •21. 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
• •22. 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
• •23. Hematological conditions that may interfere with HbA1c measurement (e.g.: hemolytic anemia, hemoglobinopathies)
• •24. Scheduled for surgery requiring hospitalization during the study period or requires surgical treatment
• •25. Positive pregnancy test, pregnant or lactating women
• •26. Considered inappropriate as a study subject by the investigator for other reasons