NCT06737042已完成2 期
EFFICACY AND SAFETY OF GZR18 INJECTED EVERY 2 WEEKS (Q2W) IN PARTICIPANTS WITHOUT TYPE 2 DIABETES, WHO HAVE OBESITY OR ARE OVERWEIGHT: A RANDOMIZED, TIRZEPATIDE- AND PLACEBO-CONTROLLED STUDY
Gan and Lee Pharmaceuticals, USA40 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2025年2月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 试验地点
- 40
- 主要终点
- Primary Objective
研究概览
简要总结
This is a Phase 2 study to evaluate the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with weight-related comorbidities (excluding type 2 diabetes mellitus).
详细描述
This is a Phase 2 multicenter, randomized, parallel-group, partially-blinded, placebo and tirzepatide-controlled study of the safety and efficacy of 24, 36, and 48 mg GZR18 (Q2W) compared with placebo and 15 mg tirzepatide (QW). The study will evaluate weight management in participants with obesity (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with weight-related comorbidities (excluding type 2 diabetes mellitus).
The study will comprise a 2-week screening period (Days -14 to -1), a 36-week treatment period (Weeks 0 to 36), which includes a titration period and a maintenance dose period, and a safety follow-up period of 2 weeks after the primary endpoint assessment (ie, 4 weeks after the last GZR18 dose and 3 weeks after the last tirzepatide dose).
Approximately 285 participants will be randomized at Week 0 into 1 of 4 groups, stratified by sex. The study will be partially-blinded (intragroup blinded); treatment in the GZR18 groups will be blinded (GZR18 vs placebo), but GZR18 vs tirzepatide will be unblinded.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years of age (both inclusive) at the time of signing the informed consent form (ICF).
- •History of failing to lose sufficient weight with lifestyle/dietary modification.
- •BMI ≥30.0 kg/m2, or
- •BMI ≥27.0 kg/m2 with at least 1 of the following:
- •Hypertension: defined as taking blood pressure (BP) lowering medication or have a systolic blood pressure (SBP) of ≥130 mmHg or a diastolic blood pressure (DBP) of ≥80 mmHg at screening.
- •Dyslipidemia: defined as taking lipid-lowering medication or have LDL ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) <40 mg/dL (1.0 mmol/L) for men or HDL <50 mg/dL (1.3 mmol/L) for women at screening.
- •Obstructive sleep apnea.
- •Cardiovascular disease: defined as having eg, ischemic cardiovascular disease or New York Heart Association (NYHA) Functional Classification Class I to II heart failure.
- •4. In the investigator's opinion, are well motivated, capable, and willing to:
- •Learn how to self-inject the IP as required for this protocol (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the IP; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IP).
- •Inject the IP (or receive an injection from a trained individual if visually impaired or with physical limitations).
- •Follow study procedures for the duration of the study, including, but not limited to, lifestyle advice (eg, dietary changes and physical activity plan), complete the electronic diary (eDiary), and complete required questionnaires.
- •Identify the biological sex for the study stratification. 5.Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Exclusion Medical Conditions Related to Obesity
- •A self-reported change (increase or decrease) in body weight >5 kg within 3 months prior to screening.
- •Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening).
- •Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening, including but not limited to:
- •Mucosal ablation
- •Gastric artery embolization
- •Intragastric balloon
- •Duodenal-jejunal endoluminal liner Related to Diabetes
- •History of type 1 or T2DM, history of ketoacidosis, or hyperosmolar state/coma.
- •At least 1 laboratory value suggestive of diabetes during screening, including 1 or more of HbA1c ≥6.5% (48 mmol/mol), fasting serum glucose ≥126 mg/dL (7.0 mmol/L), or random glucose ≥200 mg/dL (11.1 mmol/L).
- •Other Medical Conditions
- •Renal impairment measured as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, calculated by chronic kidney disease-epidemiology collaboration (CKD-EPI) as determined by central laboratory during screening.
- •Known clinically significant gastric emptying abnormality (eg, severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility.
- •History of acute or chronic pancreatitis. A participant with a history of acute pancreatitis caused by gallstones may be included in the study if the participant has a cholecystectomy to resolve the problem.
- •Thyroid-stimulating hormone (TSH) outside of the range of 0.4 to 6.0 mIU/L at screening.
- •Note: Participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 6 months.
- •Note: TSH values above the normal range can, in some participant, suggest subclinical hypothyroidism. If, in the investigator's opinion, the participant has subclinical hypothyroidism and may require initiation of thyroid hormone replacement during the study, the participant should be excluded from the study.
- •Obesity induced by other endocrinologic disorders (eg, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (eg, melanocortin 4 receptor deficiency or Prader-Willi syndrome).
- •History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (eg, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years.
- •Note: Participants with MDD or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications.
- •A history of suicide attempt.
- •Patient health questionnaire-9 (PHQ-9) score of 15 or more at screening.
- •On the Columbia Suicide Severity Rating Scale (C-SSRS) prior to randomization:
- •a "yes" answer to Question 4 (active suicidal ideation with some intent to act, without specific plan) on the "suicidal ideation" portion of the C-SSRS or
- •a "yes" answer to Question 5 (active suicidal ideation with specific plan and intent) on the "suicidal ideation" portion of the C-SSRS or
- •a "yes" answer to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) on the "suicidal behavior" portion of the C-SSRS and
- •the ideation or behavior occurred within the past month
- •Uncontrolled hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg). If a participant is on antihypertensive therapies, doses must be stable for 30 days prior to screening. For participants with uncontrolled hypertension at screening, antihypertensive medication may be started or adjusted. BP must meet the protocol criterion for hypertension control with stable treatment for at least 30 days before re-screening.
- •An elevated resting pulse rate >100 bpm at baseline.
- •Any of the following cardiovascular conditions within 3 months prior to screening:
- •Acute myocardial infarction
- •Cerebrovascular accident (stroke)
- •Unstable angina
- •Hospitalization due to congestive heart failure (CHF)
- •Ongoing or history of frequent intermittent or chronic tachyarrhythmia syndromes (eg, atrial fibrillation, supraventricular tachycardia, and positional orthostatic tachycardia syndrome).
- •Note: Participants with a history of premature atrial contractions or premature ventricular contractions may be included.
- •NYHA Functional Classification III or IV CHF.
- 另有 55 项未显示
排除标准
- 未提供
研究组 & 干预措施
24 mg GZR18 group
Experimental
24 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)
干预措施: GZR18 (Drug)
36 mg GZR18 group
Experimental
36 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)
干预措施: GZR18 (Drug)
48 mg GZR18 group
Experimental
48 mg GZR18 group: 76 participants (57 receiving GZR18 and 19 receiving placebo)
干预措施: GZR18 (Drug)
Tirzepatide group
Active Comparator
Tirzepatide group: 57 participants receiving 15 mg tirzepatide
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Primary Objective
时间窗: 36 weeks
To demonstrate that GZR18 24 mg, 36 mg, and 48 mg is superior to placebo based on percentage change in body weight after 36 weeks of treatment
次要结局
未报告次要终点
研究者
研究点 (40)
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