Can a special medical nutrition product help keep muscle during GLP-1 weight-loss treatment?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled trial in adults with overweight or obesity initiating GLP‑1 receptor agonists or dual GIP/GLP‑1 therapy. Participants are randomized 1:1 to receive either the FSMP (Myosave®) or a matching placebo for 24 weeks while continuing standard GLP‑1–based treatment. Appendicular skeletal muscle mass (ASMM) is measured by bioelectrical impedance vector analysis (BIVA) at baseline and at weeks 8, 16, and 24, with diet protein targets set to 0.9–1.1 g/kg ideal body weight. The study tests whether targeted nutritional support can reduce lean mass loss during pharmacologically assisted weight loss and improve functional outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years and ≤ 65 years old;
* BMI ≥ 30 Kg/m2 and ≤45 kg/m2
* BMI from 27 kg/m2 to 30 Kg/m2 with at least one associated co-morbidity related to overweight \[e.g. dysglycemia (pre-diabetes and/or metabolic syndrome), hypertension, dyslipidemia, obstructive sleep apnea syndrome (OSAS\], or cardiovascular disease\]
* Starting to use a GLP-1 RAs (liraglutide, semaglutide) or dual GIP and GLP-1 RAs (tirzepatide) for weight reduction; patient can be enrolled if they start the treatment at the time of enrollment or up to 2 weeks
* Diet composition adjusted to provide 0.9-1.1 g/Kg ideal body weight proteins
* Signed informed consent

Exclusion Criteria:

* Type I and Type II diabetes; patients with pre-diabetes and/or metabolic syndrome and assuming Metformin and SGLT-2 inhibitors can be enrolled
* Monogenic obesity (Subjects with a known diagnosis of monogenic obesity, including but not limited to pathogenic mutations in LEP, LEPR, MC4R, POMC, PCSK1, or other genes known to cause monogenic forms of early-onset or syndromic obesity)
* Reduced kidney function, defined as eGFR \< 60 mL/min/1.73 m², calculated using the CKD-EPI equation (see Appendix 1)
* Oncologic patients in active treatments
* Hypersensitivity to any of the constituents of the study product
* Pregnancy
* Breastfeeding
* Use of meal replacements for a diet enriched with aminoacids and/or HMB
* Use of food supplements containing aminoacids and/or HMB; patients can be included in the study if they undergo a washout period of at least 15 days

Where it's running

• IRCCS Auxologico
  Milan, Italy Recruiting
• IRCCS San Raffaele
  Roma, Italy Recruiting
• IRCCS Istituto Clinico Humanitas
  Rozzano, Italy Recruiting

Study contacts

• Study coordinator: Maria Sole Rossato
• Email: ms.rossato@pharmanutra.it
• Phone: +390507846500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.