New study tests Muscle-Saving drink for GLP-1 weight loss patients
NCT ID NCT07393360
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a special food drink can help adults on popular weight loss drugs like Wegovy or Mounjaro keep their muscle while losing weight. About 144 overweight or obese adults will take the drink or a placebo for 24 weeks. Researchers will measure changes in muscle mass and strength to see if the drink helps preserve muscle better than placebo.
Why investors are watching
PharmaNutra is testing whether its medical food can preserve muscle mass in people losing weight on GLP-1 drugs, a common side effect of these treatments. For a small company, a positive result could give it a niche product tied to a booming class of weight-loss medications. The trial's outcome matters because it could open a new revenue stream beyond its existing nutrition products.
If it works: If the trial succeeds, PharmaNutra could market the product to the large and growing number of GLP-1 users who want to avoid muscle loss. That could create a new sales channel and attract partnership interest from larger drugmakers.
If it fails: The trial could fail to show a meaningful difference from placebo, which happens often in nutrition studies. A negative or delayed readout would leave the company without a new growth driver and could hurt investor confidence in its pipeline.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS Auxologico
RECRUITINGMilan, 20145, Italy
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IRCCS Istituto Clinico Humanitas
RECRUITINGRozzano, 20089, Italy
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IRCCS San Raffaele
RECRUITINGRoma, 00163, Italy
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Other studies related to the condition(s) this trial covers.
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