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Weight-Loss drug breakthrough: protein may protect muscle mass

NCT ID NCT07495904

Disease control Sponsor: Hellenic Mediterranean University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether adding extra protein to the diet can help adults with obesity keep their muscle while losing weight with GLP-1 medications. About 130 people aged 30-65 with a BMI over 30 will take part. Half will get standard medication alone, and the other half will also receive guidance to eat more protein. The goal is to see if this approach prevents muscle loss during weight loss.

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 130 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 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: * Adults 30-65 years old * BMI: ≥30 kg/m² * Signed Informed Consent Exclusion Criteria: A. Metabolic and Medical Conditions: * Uncontrolled type 2 diabetes (HbA1c \> 9.0%) * Known cardiovascular disease (e.g., coronary artery disease, heart failure NYHA 3-4) * Chronic kidney disease stage 4-5 (GFR \<60 ml/min) * Liver disease (known hepatitis, ALT ≥ 3 or total bilirubin ≥ 2 times ULN) * Inflammatory bowel disease * Celiac disease * History of pancreatitis * Any disorder potentially causing malabsorption * Active cancer or history of malignancy within the past 3 years * Psychiatric disorders affecting adherence or assessment B. Medication and Supplement Use * Chronic use of medications affecting metabolism or body composition (e.g., corticosteroids, anti-obesity drugs) * Use of anti-inflammatory or antioxidant medications * Use of probiotics, prebiotics, or laxatives within the last month * Unstable medication regimen (changes within the past 3 months) * Use of protein and creatine supplements. C. Dietary and Lifestyle Factors: * Alcohol or substance abuse * Engagement in intense regular physical activity D. Reproductive Status: * Pregnancy or breastfeeding * Pregnancy within the past 12 months * Plans to become pregnant during the study E. Other: \- Any condition that, in the opinion of the Investigator, may interfere with participation, adherence, or the interpretation of study results.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 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

  • 1st Department of Internal Medicine, University General Hospital of Heraklion

    RECRUITING

    Heraklion, Greece

  • Human Dietetics & Body Composition Laboratory, Department of Nutrition and Dietetics Sciences, Hellenic Mediterranean University

    RECRUITING

    Heraklion, Greece

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