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Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

Plain-language guide to NCT06579105: phase 2 randomized trial of Semaglutide, 406 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06579105
Phase
phase 2
Status
completed
Start
2024-10-08
Completion (planned or actual)
2025-12-19
Participants
406 (actual)
Design
randomized, triple-blind, treatment
Conditions studied
Diabetes Mellitus, Type 2
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Semaglutide.

It had eight arms (groups): Arm 1 (experimental), Arm 2 (experimental), Arm 3 (experimental), Arm 4 (experimental) and Arm 5 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.

Who Took Part

Enrollment: 406 actual participants took part.

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.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2024-10-08 with completion listed for 2025-12-19.

It ran at 97 sites in United States (50), Poland (8), Spain (7), United Kingdom (7), Canada (6) and Germany (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: Baseline to Week 26).

It also tracked 6 secondary outcomes, for example Change in fasting glucose, Percent change in body weight and Absolute change in body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 406 people.

The trial is marked completed; 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.