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Semaglutide as an Adjunct to Dieting in the Treatment of Type 2 Diabetes

Plain-language guide to NCT04854083: phase 4 randomized trial of Semaglutide, 50 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04854083
Phase
phase 4
Status
status unknown
Start
2022-02-17
Completion (planned or actual)
2025-08
Participants
50 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Type2 Diabetes
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Semaglutide.

However, focus on long-term management of body weight, which is an essential part of treatment success, is often lacking.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Additionally, a reference group of healthy normal weight non-diabetic individuals (BMI ≤ 25 kg/m2, n=25, aged ≥18 to \< 65 years) are included as controls at the initiation of the study.

Who Took Part

50 planned participants were the target.

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: Age ≥18 years and \<65 years. BMI: ≥27 kg/m2. Participant is willing and able to give informed consent for participation in the study.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: contraindication to trial drugs; use of insulin or glp-1ras (during the past 3 months); use of anti-obesity drugs (during the past 3 months).

How the Study Was Run

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

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.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2022-02-17 with completion listed for 2025-08.

It ran at 1 site in Finland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c (time frame: from baseline to 12 months).

It also tracked 16 secondary outcomes, for example HbA1c, Fasting plasma glucose, Body weight, Waist circumference, Change in appetite and eating habits, control of eating and Change in appetite and eating habits, binge eating.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 50 people.

Its status is unknown; 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.