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Semaglutide [amount hidden] in Patients With Poor Weight-loss

Plain-language guide to NCT05073835: phase 3 randomized trial of Semaglutide, fat loss, obesity & body recomposition, 70 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05073835
Phase
phase 3
Status
active, not recruiting
Start
2022-11-01
Completion (planned or actual)
2025-03
Participants
70 (actual)
Design
randomized, triple-blind, treatment
Conditions studied
Obesity; Diabetes; Metabolic Syndrome
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Semaglutide for fat loss, obesity & body recomposition.

It had two arms (groups): Intervention (experimental) and Control (placebo comparator).

Placebo administration, once weekly, subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 70 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Adults, 18-65 years inclusive. Fluent in English and able to understand and complete questionnaires. Participants capable to provide written informed consent and comply with the trial protocol.

The full record lists 7 inclusion and 21 exclusion criteria; among the exclusions: bariatric surgical procedure other than gb and sg, or revision bariatric surgery of any operation type; personal history of type i diabetes or type ii diabetes mellitus currently treated with insulin; concomitant use of glp-1r agonist or dppiv-inhibitors.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2022-11-01 with completion listed for 2025-03.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage Weight Change (time frame: Baseline and week 68).

It also tracked 12 secondary outcomes, for example Categorical Weight Loss, Body Mass Index (BMI), Body Composition, Blood Pressure Change, Cardiovascular Outcome - Heart Rate and HbA1c.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 70 people with fat loss, obesity & body recomposition.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.

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.