Obesity & OverweightMYO-PRESERVENCT07393360
Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
A study testing Myosave® in people with Obesity & Overweight, run by Pharmanutra S.p.a. at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Myosave®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 3 sitesItaly
- Study dates
- 11 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Auxologico
Milan, 20145
Simona Bertoli, Prof., +39 349 8130845, simona.bertoli@unimi.it
Simona Bertoli, Prof.
- Recruiting
IRCCS San Raffaele
Roma, 00163
Massimiliano Caprio, Prof., +39 06 52253419, massimiliano.caprio@sanraffaele.it
Massimiliano Caprio, Prof.
- Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Roberto Vettor, Prof., +39 3356108167, roberto.vettor@humanitas.it
Roberto Vettor, Prof.
About this study
Official 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
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).
Read the 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 clinical management. Participants are randomized in a 1:1 ratio to receive either the FSMP or a matching placebo for 24 weeks, in addition to their ongoing GLP-1 RA or dual GIP/GLP-1 RA therapy. Study visits occur at baseline, 8 weeks, 16 weeks, and 24 weeks.
This trial aims to determine whether targeted nutritional support can mitigate the loss of lean mass commonly observed during pharmacologically assisted weight loss, thereby improving functional outcomes and overall patient well-being.
- Conditions
- Obesity & Overweight
- Being tested
- Myosave®, Placebo
- Keywords
- Weight Loss, Muscle Mass Preservation, Obesity, Body Composition, BIVA
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myosave®Dietary supplement
A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.
PlaceboOther
Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8, Week 16, Week 24
Secondary outcomes (5)
Handgrip Strength
Handgrip strength will be measured with a calibrated dynamometer on both dominant and non-dominant hands to evaluate changes in muscle function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start11 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmanutra S.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sintesi Research Srl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393360
- Sponsor's protocol ID
- MYO-PRESERVE
- Acronym
- MYO-PRESERVE
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07393360
- Acronym / sponsor ID
- MYO-PRESERVE / MYO-PRESERVE
- Conditions
- Obesity & Overweight
- Keywords
- Weight Loss, Muscle Mass Preservation, Obesity, Body Composition, BIVA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Pharmanutra S.p.a.Industry (pharma, biotech, devices)
- Collaborators
- Sintesi Research Srl
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 clinical management. Participants are randomized in a 1:1 ratio to receive either the FSMP or a matching placebo for 24 weeks, in addition to their ongoing GLP-1 RA or dual GIP/GLP-1 RA therapy. Study visits occur at baseline, 8 weeks, 16 weeks, and 24 weeks.
This trial aims to determine whether targeted nutritional support can mitigate the loss of lean mass commonly observed during pharmacologically assisted weight loss, thereby improving functional outcomes and overall patient well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myosave® | Experimental | Dietary Supplement: Myosave®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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myosave®A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks. | Dietary supplement | Myosave® |
| PlaceboMaching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks | Other | Placebo |
Primary outcome
Change in Appendicular Skeletal Muscle Mass (ASMM)
Time frame: Baseline, Week 8, Week 16, Week 24
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.
5 secondary outcomes
Handgrip Strength
Time frame: Baseline, Week 8, Week 16, Week 24
Change in Fat-Free Mass (FFM)
Time frame: Baseline, Week 8, Week 16, Week 24
Change in Fat Mass (FM)
Time frame: Baseline, Week 8, Week 16, Week 24
Change in Health-Related Quality of Life (Short Form-36 Health Survey, SF-36)
Time frame: Baseline, Week 8, Week 16, Week 24
Change in Body Weight (kg)
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myosave® in people with Obesity & Overweight, run by Pharmanutra S.p.a. at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Sole Rossato (+390507846500, ms.rossato@pharmanutra.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Appendicular Skeletal Muscle Mass (ASMM) (time frame: Baseline, Week 8, Week 16, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.