Efficacy of Oral Semaglutide in Overweight or Obesity

Plain-language guide to NCT05442450: phase 4 randomized trial of Semaglutide, fat loss, obesity & body recomposition, 116 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05442450
Phase: phase 4
Status: status unknown
Start: 2022-07-10
Completion (planned or actual): 2023-06-30
Participants: 116 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Obesity; Weight Loss
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Semaglutide for fat loss, obesity & body recomposition.

All the eligible participants after screening will be randomized into two groups (Group 1 and 2) by block randomization (block size of 4 and 6) using computer generated random number.

Randomization is performed by the individual not involved in the study.

It had two arms (groups): Diet+excercise+oral semaglutide (experimental) and Diet+excercise (no intervention).

The registry classes the interventions as drug.

Who Took Part

116 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: • diabetes mellitus; A history of chronic pancreatitis; acute pancreatitis within 180 days before enrolment.

How the Study Was Run

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

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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 2022-07-10 with completion listed for 2023-06-30.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example The percentage change in body weight from baseline to week 28, Change in waist circumference, Change in body mass index (BMI), Change in systolic blood pressure, Change in diastolic blood pressure and Change in fasting serum insulin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 116 people with fat loss, obesity & body recomposition.

Its status is unknown; 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).

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.