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Efficacy And Safety of MET097 Once Weekly In People With Overweight or Obesity (VESPER-4)
EU CTIS ID: 2025-523974-18-00
What this study is testing
To demonstrate the superiority of CCI mg once-weekly (QW) MET097, compared with placebo, in percent change from baseline body weight at Week 64
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
- United Kingdom
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada; United Kingdom; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.