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Clinical Trial NCT07393360 (MYO-PRESERVE) for Obesity & Overweight is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment (MYO-PRESERVE) 144
Clinical Trial NCT07393360 (MYO-PRESERVE) is an interventional study for Obesity & Overweight that is recruiting. It started on December 11, 2025 with plans to enroll 144 participants. Led by Pharmanutra S.p.a., it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on March 23, 2026.
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 A...Show More
Detailed Description
This randomized, double-blind, placebo-controlled investigates whether a Food for Special Medical Purposes (FSMP) can help preserve appendicular skeletal muscle mass (ASMM) in adults undergoing weight loss treatment with GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists.
Eligible participants are adults with obesity or overweight with comorbidities who are initiating GLP-1-based therapy as part of standard...
Show MoreOfficial Title
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
Conditions
Obesity & OverweightOther Study IDs
- MYO-PRESERVE
NCT ID Number
Start Date (Actual)
2025-12-11
Last Update Posted
2026-03-23
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
144
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Weight Loss
Muscle Mass Preservation
Obesity
Body Composition
BIVA
Muscle Mass Preservation
Obesity
Body Composition
BIVA
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalMyosave® 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. | Myosave® A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks. |
Placebo ComparatorPlacebo Participants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy. | Placebo Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Handgrip Strength | Handgrip strength will be measured with a calibrated dynamometer on both dominant and non-dominant hands to evaluate changes in muscle function. | Baseline, Week 8, Week 16, Week 24 |
Change in Fat-Free Mass (FFM) | Change in Fat-Free Mass measured using Bioelectrical Impedance Vector Analysis (BIVA). Continuous variable reported according to device output. | Baseline, Week 8, Week 16, Week 24 |
Change in Fat Mass (FM) | Change in Fat Mass measured using Bioelectrical Impedance Vector Analysis (BIVA). Continuous variable reported according to device output. | Baseline, Week 8, Week 16, Week 24 |
Change in Health-Related Quality of Life (Short Form-36 Health Survey, SF-36) | The Short Form-36 Health Survey (SF-36) assesses physical and mental health-related quality of life.
The scale consists of 36 items scored into 8 domains. Each domain score ranges from 0 to 100, where higher scores indicate better health status.
Domains include: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. | Baseline, Week 8, Week 16, Week 24 |
Change in Body Weight (kg) | Change in body weight measured in kilograms from baseline to Week 24. Continuous variable reported according to standard clinical procedures. | Baseline to Week 24 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Pharmanutra S.p.a.Sintesi Research SrlStudy Central Contact
Contact: Maria Sole Rossato, +390507846500, [email protected]
3 Study Locations in 1 Countries
IRCCS Auxologico, Milan, 20145, Italy
Simona Bertoli, Prof., Contact, +39 349 8130845, [email protected]
Simona Bertoli, Prof., Principal Investigator
Recruiting
IRCCS San Raffaele, Roma, 00163, Italy
Massimiliano Caprio, Prof., Contact, +39 06 52253419, [email protected]
Massimiliano Caprio, Prof., Principal Investigator
Recruiting
IRCCS Istituto Clinico Humanitas, Rozzano, 20089, Italy
Roberto Vettor, Prof., Contact, +39 3356108167, [email protected]
Roberto Vettor, Prof., Principal Investigator
Recruiting