跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT07192263
NCT07192263尚未招募3 期

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

HK inno.N Corporation0 个研究点目标入组 300 人开始时间: 2025年9月22日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
干预措施

试验速览

阶段
3 期
状态
尚未招募
入组人数
300
主要终点
Percent change in body weight from baseline at Week 40
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

IN-B00009

Experimental

干预措施: IN-B00009 (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Percent change in body weight from baseline at Week 40

时间窗: Baseline, 40 weeks

Proportion of subjects with ≥5% body weight loss from baseline at Week 40

时间窗: Baseline, 40 weeks

次要结局

  • Percent change in body weight from baseline at Week 24(Baseline, 24 weeks)
  • Proportion of subjects with ≥15% body weight loss from baseline at Week 24 and Week 40(Baseline, 24 weeks, 40 weeks)
  • Change in body weight from baseline at Week 24 and Week 40(Baseline, 24 weeks, 40 weeks)
  • Proportion of subjects with ≥5% body weight loss from baseline at Week 24(Baseline, 24 weeks)
  • Change in waist circumference from baseline at Week 24 and Week 40(Baseline, 24 weeks, 40 weeks)
  • Percent change in lipids from baseline at Week 24 and Week 40(Baseline, 24 weeks, 40 weeks)
  • Change in glucose metabolism parameters from baseline at Week 24 and Week 40(Baseline, 24 weeks, 40 weeks)
  • Change in blood pressure(systolic, diastolic) from baseline at Week 24 and Week 40(Baseline, 24 weeks, 40 weeks)
  • Change in SF-36(36-Item Short Form Survey) scores from baseline at Week 24 and Week 40(Baseline, 24 weeks, 40 weeks)
  • Proportion of subjects with ≥10% body weight loss from baseline at Week 24 and Week 40(Baseline, 24 weeks, 40 weeks)
  • Change in BMI from baseline at Week 24 and Week 40(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(Baseline, 24 weeks, 40 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

相似试验

进行中（未招募）
3 期
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar SpineLumbar Degenerative Disc Disease
NCT05516992Spine BioPharma, Inc400
已完成
3 期
Phase III clinical trial comparing safety and efficacy of BCD-022 (CJSC BIOCAD, Russia) used with paclitaxel to Herceptin® used with paclitaxel in the first-line treatment of HER2 positive metastatic breast cancer patients.
CTRI/2014/07/004722BIOCAD INDIA PVT LTD206
尚未招募
3 期
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
NCT06929325CSPC ZhongQi Pharmaceutical Technology Co., Ltd.312
撤回
3 期
A Study to Evaluate the Efficacy and Safety of REL-1017 As Adjunctive Treatment of Major Depressive Disorder (MDD)Major Depressive Disorder (MDD)
NCT06735079MGGM LLC146
已完成
3 期
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary CirrhosisPBC
NCT06715319Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.100