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Recruiting Phase 3 2025-523974-18-00

EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY- BIASED ULTRA LONG-ACTING GLP-1RA IN PEOPLE WITH OVERWEIGHT OR OBESITY: A PHASE 3, MULTI-CENTER RANDOMIZED, CONTROLLED TRIAL (VESPER-4)

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, Occurrence at Week 64 of: • CCI % of reduction from baseline body weight • CCI% of reduction from baseline body weight • CCI % of reduction from baseline body weight • O CCI % of reduction from baseline body weight, Change from baseline at Week 64 in: • 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 Percent change from baseline in body weight at Week 64
Description
Change from baseline in body weight (kg) at Week 64, Occurrence at Week 64 of: • CCI % of reduction from baseline body weight • CCI% of reduction from baseline body weight • CCI % of reduction from baseline body weight • O CCI % of reduction from baseline body weight, Change from baseline at Week 64 in: • 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
Who can participate
Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 894 participants
Interventions
MET097 matching placebo
Drug
MET097 Injection, 5mg/mL
Drug
Locations 8
Bulgaria (1)
Czech Republic (1)
Germany (1)
Hungary (1)
Poland (1)
Romania (1)
Slovakia (1)
Spain (1)
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.04.2026
Registry ID
2025-523974-18-00
Source
euclinicaltrials.eu
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