VESPER-2
Research type
Research Study
Full title
A Phase 2b, Multi-Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults with Obesity or Overweight, and Type 2 Diabetes Mellitus (VESPER-2)
IRAS ID
1011787
Contact name
Kelsey Sturm
Contact email
Sponsor organisation
Metsera, Inc.
Research summary
The purpose of this research study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of four different dose levels of MET097 when administered as subcutaneous (SC) injection (under the skin) once weekly for 28 weeks in adult participants with both obesity or overweight and a diagnosis of Type 2 Diabetes. PK or Pharmacokinetics is the study of how a drug is absorbed, distributed, degraded, and
eventually eliminated by the body. Blood samples will be taken throughout the study for PK analysis. Another objective of the study
is to evaluate the effect of MET097 on your body weight and body mass index (BMI), also called pharmacodynamics (PD).
PD or Pharmacodynamics is the study of how drugs affect the body. This involves understanding the interaction between drugs and cells, tissues, and organs within the body.
The study medication (MET097) will be in solution form and will be given by subcutaneous (under the skin) injection in the abdomen (the belly button area).
The participant may be given placebo (a harmless dummy substance that looks like MET097 without any active study drug) instead of MET097.
This is a “double-blind” study. This means that neither the participant, nor the study staff, will know if the participants are taking MET097 or placebo.
The duration of the participation in this study will be approximately 43 weeks including the Screening period (up to 4-week), Treatment period (28-week) and post-treatment follow-up (12 weeks after the last dose).
Screening will occur no more than 28 days prior to taking the study medication.
Approximately 125 adult male or female participants, between the ages of 18 and 75, will be included in this research study.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0059
Date of REC Opinion
22 Apr 2025
REC opinion
Further Information Favourable Opinion