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)
Phase 3 – large-scale trial before approval
Conditions:
Obesity
Sponsor: Metsera Inc.
trial.available_in:
БГ
Overview
Trial status: Authorised
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
Percent change from baseline in body weight at Week 64
Description
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
Who can participate
Age group: 65+ years, 18-64 years
Gender: Female, Male
Target enrollment: 919 participants
БГ