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New study tests Muscle-Saving drink for GLP-1 weight loss patients

NCT ID NCT07393360

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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.

Obesity obesity disorder Overweight Weight Loss

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • IRCCS Auxologico

    RECRUITING

    Milan, 20145, Italy

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • IRCCS San Raffaele

    RECRUITING

    Roma, 00163, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.