RecruitingNot ApplicableNCT07393360

Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment

Evaluating the Effect of a Food for Special Medical Purposes Containing Essential Amino Acids (EAA), Carnitine, Arginine, and Sucrosomial Minerals on the Preservation of Appendicular Skeletal Muscle Mass (ASMM) During a Weight Loss Program With GLP-1 Receptor Agonists


Sponsor

Pharmanutra S.p.a.

Enrollment

144 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Myosave® and Placebo for people with obesity, overweight. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMyosave®

A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.

OTHERPlacebo

Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks


Locations(3)

IRCCS Auxologico

Milan, Italy

IRCCS San Raffaele

Roma, Italy

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

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NCT07393360


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