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EFFICACY AND SAFETY OF MET097 ONCE WEEKLY IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES (VESPER-5)
EU CTIS ID: 2025-523975-48-00
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 ≥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 1. 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
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
- 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
See the full eligibility criteria
- 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 1. 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Argentina
- Canada
- United Kingdom
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; Argentina; Canada; United Kingdom. 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.