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

NCT07393360 | Recruiting

• 1 other identifier: MYO-PRESERVE
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Obesity & Overweight

Keywords

Weight Loss; Muscle Mass Preservation; Obesity; Body Composition; BIVA

Outcome Measures

Primary Outcomes (1)

• Change in Appendicular Skeletal Muscle Mass (ASMM)

  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.

  Baseline, Week 8, Week 16, Week 24

Secondary Outcomes (5)

• Handgrip Strength

  Baseline, Week 8, Week 16, Week 24

• Change in Fat-Free Mass (FFM)

  Baseline, Week 8, Week 16, Week 24

• Change in Fat Mass (FM)

  Baseline, Week 8, Week 16, Week 24

• Change in Health-Related Quality of Life (Short Form-36 Health Survey, SF-36)

  Baseline, Week 8, Week 16, Week 24

• Change in Body Weight (kg)

  Baseline to Week 24

Study Arms (2)

Myosave®

EXPERIMENTAL

Participants receive Myosave® twice daily (two sachets/day) for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy.

Dietary Supplement: Myosave®

Placebo

PLACEBO COMPARATOR

Participants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy.

Other: Placebo

Interventions

Placebo OTHER

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

Placebo

Myosave® DIETARY_SUPPLEMENT

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

Myosave®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanutra S.p.a.: lead
• Sintesi Research Srl: collaborator

Study Sites (3)

IRCCS Auxologico

Milan, 20145, Italy

RECRUITING

IRCCS San Raffaele

Roma, 00163, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Maria Sole Rossato

CONTACT

+390507846500; ms.rossato@pharmanutra.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active product and placebo are indistinguishable in appearance, packaging, and administration schedule.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 6, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-01

Locations

IT (3)