Can a special medical nutrition product help keep muscle during GLP-1 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
This trial tests whether Myosave®, a medical nutrition product, helps adults with overweight or obesity who are starting GLP‑1 or dual GIP/GLP‑1 weight‑loss medications keep appendicular skeletal muscle mass during 24 weeks of treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Pharmanutra S.p.a. Industry-sponsored |
| Locations | 3 sites (Milan and 2 other locations) |
| Trial ID | NCT07393360 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 with BMI ≥30 to ≤45 kg/m2 (or 27–30 kg/m2 with related comorbidities) who are starting GLP‑1 or dual GIP/GLP‑1 therapy and can follow the prescribed protein intake and study visit schedule.
Not a fit: Patients with type 1 or type 2 diabetes, known monogenic obesity, those not using GLP‑1/dual GIP‑GLP‑1 agents, or those outside the age/BMI ranges are unlikely to benefit or are ineligible for this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce loss of muscle mass during GLP‑1–related weight loss and help preserve strength and physical function.
How similar studies have performed: Prior research on higher-protein diets and targeted nutrition shows some ability to preserve lean mass during weight loss, but combining an FSMP specifically with GLP‑1 or dual GIP/GLP‑1 therapy is a relatively new and less-tested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.