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

Официальное название

A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes Mellitus

Обзор

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

Вмешательства

• Препарат IN-B00009
  Test drug
• Препарат Placebo
  Placebo drug

Первичные конечные точки

• Percent change in body weight from baseline at Week 40 [Срок оценки: Baseline, 40 weeks]
• Proportion of subjects with ≥5% body weight loss from baseline at Week 40 [Срок оценки: Baseline, 40 weeks]

Вторичные конечные точки (12)

• Percent change in body weight from baseline at Week 24 [Срок оценки: Baseline, 24 weeks]
• Proportion of subjects with ≥5% body weight loss from baseline at Week 24 [Срок оценки: Baseline, 24 weeks]
• Proportion of subjects with ≥10% body weight loss from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Proportion of subjects with ≥15% body weight loss from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Change in body weight from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Change in BMI from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Change in waist circumference from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Change in glucose metabolism parameters from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Percent change in lipids from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Change in blood pressure(systolic, diastolic) from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Change in IWQOL-Lite-CT(Impact of Weight on Quality of Life-Lite for Clinical Trials version) (Physical function domain) from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]
• Change in SF-36(36-Item Short Form Survey) scores from baseline at Week 24 and Week 40 [Срок оценки: Baseline, 24 weeks, 40 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07192263 · IN_ECN_301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗