2025-523975-48-00招募中3 期
EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1 RA IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)
Metsera Inc.115 个研究点 分布在 4 个国家目标入组 919 人开始时间: 2026年5月15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
- 919
- 试验地点
- 115
- 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 ≥27.0 kg/m2
- •Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria
- •Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit
- •T2DM may be treated with: a. Diet and exercise alone or in combination with • Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin
- •In the investigator’s opinion, are well-motivated, capable, and willing to • CCI • Self-inject study drug (or receive an injection from a trained family member or caregiver if visually impaired or with physical limitations) • Perform finger stick blood glucose (BG) monitoring, including weekly fasting glucose measurements • 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
- •Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM
- •History of ketoacidosis or hyperosmolar state within 1 year prior to Screening
- •Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening
- •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
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
- Change in HbA1c (%) from baseline at Week 64
- Occurrence at Week 64 of: o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight o CCI % of reduction from baseline body weight
- Change from baseline at Week 64 in: o 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
- Change in HbA1c (%) from baseline at Week 84
研究者
Clinical trial information desk
Scientific
Metsera Inc.
研究点 (115)
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