Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
Myosave®: A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.
Placebo: Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks
Study summary
This study evaluates whether a Food for Special Medical Purposes (FSMP) can help to preserve appendicular skeletal muscle mass (ASMM) in adults undergoing weight loss treatment with GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists. Participants will receive the FSMP or a matching placebo for 24 weeks while continuing standard GLP-1-based therapy. ASMM will be measured using Bioelectrical Impedance Vector Analysis (BIVA).
Eligibility
Primary outcome measure(s)
- Change in Appendicular Skeletal Muscle Mass (ASMM) — Baseline, Week 8, Week 16, Week 24
ASMM will be assessed using Bioelectrical Impedance Vector Analysis (BIVA). The primary endpoint is the change in ASMM from baseline to Week 24 to determine whether the Food for Special Medical Purposes (FSMP) preserves skeletal muscle mass compared with placebo.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS Auxologico | Milan | Italy | Recruiting |
| IRCCS San Raffaele | Roma | Italy | Recruiting |
| IRCCS Istituto Clinico Humanitas | Rozzano | Italy | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07393360 on ClinicalTrials.gov ↗ ← All trials in Italy