2025-523974-18-00招募中3 期
EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1RA IN PEOPLE WITH OVERWEIGHT OR OBESITY: A PHASE 3, MULTI-CENTER RANDOMIZED, CONTROLLED TRIAL (VESPER-4)
Metsera Inc.125 个研究点 分布在 3 个国家目标入组 894 人开始时间: 2026年4月30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
- 招募中
- 发起方
- 入组人数
- 894
- 试验地点
- 125
- 主要终点
- Percent change from baseline in body weight at Week 64
研究概览
简要总结
To demonstrate the superiority of CCI mg once-weekly (QW) MET097, compared with placebo, in percent change from baseline body weight at Week 64
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form (ICF)
- •Male or female adults, aged ≥18 years
- •Have a BMI at Screening of a. BMI ≥30 kg/m2 (may or may not have the weight-related co-morbidities listed below) OR b. BMI ≥27.0 kg/m2 to <30.0 kg/m2 must have at least one of the following weight-related co-morbidities either previously diagnosed or diagnosed at Screening: • Hypertension: on stable blood pressure (BP)-lowering medication to treat BP or having systolic BP (SBP) ≥130 mmHg or diastolic BP ≥80 mmHg at Screening • Dyslipidemia: on lipid-lowering medication or having LDL-C ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or HDL-C <40 mg/dL (1.0 mmol/L) for men or HDL-C <50 mg/dL (1.3 mmol/L) for women • Clinical diagnosis of obstructive sleep apnea • Cardiovascular disease (eg, heart failure with New York Heart Association (NYHA) Functional Class I-III, history of ischemic or hemorrhagic stroke or cerebrovascular revascularization procedure [eg, carotid endarterectomy and/or stent], myocardial infarction, coronary artery disease, or peripheral vascular disease)
- •In the investigator’s opinion, are well-motivated, capable, and willing to a. CCI b. Self-inject study drug (or receive an injection from a trained family member or caregiver if visually impaired or with physical limitations) c. d. Follow trial procedures for the duration of the trial, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise plan) and complete required documentation and questionnaires
排除标准
- •Female who is breastfeeding, or who is pregnant at Screening, or prior to randomization on Day 1
- •Unwilling or unable to follow contraceptive requirements
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI Screat-Scys Combined) (using serum creatinine and serum cystatin-c combined)) at Screening
- •Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 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 3 months prior to Screening
- •Poorly controlled hypertension, defined as the following: a. Mean seated systolic BP ≥180 mm Hg or mean seated diastolic BP ≥120 mm Hg at Screening
- •Diagnosis of any form of diabetes (resolved gestational diabetes is permitted) or HbA1c ≥ 6.5% or fasting glucose >125 mg/dL (≥48 mmol/mol), random glucose ≥200 mg/dL (≥11.1 mmol/L) with classic symptoms of hyperglycemia or history of taking any medications to lower glucose within 90 days before Screening.
研究组 & 干预措施
MET097 Injection, 5mg/mL
Test
干预措施: MET097 Injection, 5mg/mL (Drug)
MET097 matching placebo
Placebo
干预措施: MET097 matching placebo (Drug)
结局指标
主要结局
Percent change from baseline in body weight at Week 64
Percent change from baseline in body weight at Week 64
次要结局
- Change from baseline in body weight (kg) at Week 64
- Occurrence at Week 64 of: • CCI % of reduction from baseline body weight • CCI% of reduction from baseline body weight • CCI % of reduction from baseline body weight • O CCI % of reduction from baseline body weight
- Change from baseline at Week 64 in: • Fasting triglycerides (mg/dL) • O Non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)
- Change from baseline in SBP (mmHg) at Week 64
- Change from baseline in Short Form 36 health survey (SF-36) physical function domain score at Week 64
- Percent change from baseline in body weight at Week 84
- Change from baseline in body weight (kg) at Week 84
研究者
Clinical trial information desk
Scientific
Metsera Inc.
研究点 (125)
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