NCT06174779已完成3 期
A Multicenter, Randomized, Double-blind, Phase 3 Study to Evaluate Efficacy and Safety of HM11260C in Adult Obesity Patients Without Diabetes Mellitus
Hanmi Pharmaceutical Company Limited2 个研究点 分布在 2 个国家目标入组 448 人开始时间: 2024年1月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 2
- 主要终点
- The percent change of body weight from baseline
研究概览
简要总结
A multicenter, randomized, double-blind, phase 3 study to evaluate efficacy and safety of HM11260C in adult obesity patients 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with following criteria :
- •BMI ≥ 30 kg/m2 or
- •27 kg/m2 ≤ BMI < 30 kg/m2 with more than one risk factors or comorbidities(hypertension, dyslipidemia, sleep apnea, cardiocerebrovascular disease)
- •A person who have failed at least once to weight control using diet and exercise therapy before screening visit.
排除标准
- •A person whose weight change exceeds 5kg within 3 months prior to screening visit.
- •Diabetes mellitus (Type 1, type 2, etc.) or HbA1c ≥ 6.5 %.
- •Administration of hypoglycemic agents.
- •Administration of medicines inducing weight gain.
- •Prader-Willi Syndrome or MC4R deficiency.
- •Cushing's Syndrome.
- •Administration of medicines for weight management.
- •A person who has a history of surgery(including device-based therapy) related to obesity or who has a plan during the clinical trial period.
- •Administration of Steroids for the systemic use.
- •Clinically significant gastric emptying abnormalities.
- •History(including family history) of medullary thyroid carcinoma or multiple endocrine adenomatosis.
- •History of acute or chronic pancreatitis.
- •A person who has the following clinical laboratory test results :
- •TSH < 0.4 mIU/L or TSH > 6 mIU/L
- •Calcitonin > 100 ng/L
- •Amylase or Lipase > 3 x UNL
- •Severe liver disease (AST or AST > 3 x UNL or Total bilirubin > 1.5 x UNL).
- •Severe renal disease ( eGFR < 30mL/min/1.73m 2 ).
- •QTc > 450 ms.
- •Answered 'yes' to question 4 or 5 of the suicidal ideation domain in C-SSRS or history of suicide attempt.
- •PHQ-9 ≥ 15 or history of depression, anxiety, and other severe Mental illness.
- •History of alcohol addiction or drug abuse.
- •History of malignant tumors.
- •History of severe heart disease or severe neurovascular disease.
- •Hypersensitivity to investigational products or multi-drug allergy.
- •Positive to pregnancy test, nursing mother, intention on pregnancy.
- •Considered by investigator as not appropriate to participate in the clinical study with other reason.
研究组 & 干预措施
HM11260C
Experimental
Weekly administration by subcutaneous injection
干预措施: HM11260C (Drug)
Placebo
Placebo Comparator
Weekly administration by subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
The percent change of body weight from baseline
时间窗: baseline, 40 weeks
The proportion of subjects achieving body weight loss ≥ 5% from baseline
时间窗: baseline, 40 weeks
次要结局
- Change of body weight from baseline(baseline, 24 weeks, 40 weeks, 64 weeks)
- Change of IWQoL-Lite-CT(Physical function domain) from baseline(baseline, 24 weeks, 40 weeks, 64 weeks)
- The proportion of subjects achieving body weight loss ≥ 5% from baseline(baseline, 24 weeks, 64 weeks)
- The percent change of body weight from baseline(baseline, 24 weeks, 64 weeks)
- The proportion of subjects achieving body weight loss ≥ 10% from baseline(baseline, 24 weeks, 40 weeks, 64 weeks)
- Change of BMI from baseline(baseline, 24 weeks, 40 weeks, 64 weeks)
- Change of waist circumference from baseline(baseline, 24 weeks, 40 weeks, 64 weeks)
- Change of blood pressure from baseline(baseline, 24 weeks, 40 weeks, 64 weeks)
- Change of glucose metabolism parameters from baseline(baseline, 24 weeks, 40 weeks, 64 weeks)
- The percentage change of lipid profile parameters from baseline(baseline, 24 weeks, 40 weeks, 64 weeks)
研究者
研究点 (2)
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