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Rebalancing the Fat Content of the Heart and Muscles

Plain-language guide to NCT07065383: not phased randomized trial of Semaglutide, 60 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07065383
Phase
not phased
Status
recruiting participants
Start
2025-08-01
Completion (planned or actual)
2028-07-31
Participants
60 (estimated)
Design
randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Diabetes Mellitus Type 2
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Semaglutide.

However, many studies show that this may not be enough.

New treatments focusing on weight loss have heralded better results.

It had two arms (groups): Semaglutide administration plus dietary counselling and physical activity encouragement (placebo comparator) and Semaglutide and supervised training program (active comparator).

Semaglutide administration plus dietary counselling and physical activity encouragement.

Semaglutide administration plus a personalised and supervised program of resistance and endurance training.

The registry classes the interventions as drug.

More on the Plan

The investigators propose to explore the effects of semaglutide administration plus dietary counselling and physical activity encouragement versus a more intensive strategy of semaglutide administration plus a personalised and supervised program of resistance and endurance exercise training.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 20 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with a confirmed diagnosis of type 2 diabetes established in the previous 10 years between the ages of 20 and 75. Patients who do not meet the WHO recommendations on physical activity (≤150 minutes per week) of moderate-vigorous physical activity (MVPA). Patients who have a BMI of ≥27 but with a body weight of less than 140kgs due to limitations of the scanner table weight limit. Able to understand written and spoken English.

The full record lists 6 inclusion and 19 exclusion criteria; among the exclusions: any previously unknown cardiac condition other than mild valvular disease; any history of known coronary artery disease (including myocardial infarction and myocardial infarction with normal coronary arteries); any relevant or untreated endocrine condition (i.e. cushings).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-08-01 with completion listed for 2028-07-31.

It ran at 1 site in United Kingdom.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: 1H-magnetic resonance spectroscopy (time frame: From enrollment to the end of treatment at the end of 12 weeks).

It also tracked 1 secondary outcome, for example Intramyocellular lipid pool compartments.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.