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Efficacy and Safety of Semaglutide Injection in Subjects With Type 2 Diabetes
Plain-language guide to NCT06339086: phase 3 randomized trial of Semaglutide, 478 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06339086
- Phase
- phase 3
- Status
- status unknown
- Start
- 2024-04
- Completion (planned or actual)
- 2025-08-30
- Participants
- 478 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Semaglutide.
It had two arms (groups): Semaglutide Injection (experimental) and Ozempic® (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 478 planned participants were the target.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female, aged ≥18 and ≤75 years old at the time of signing the ICF. Diagnosis of type 2 diabetes for at least 6 months (WHO, 1999) at screening. BMI ≥18.5 and ≤35 kg/m2 at screening.
The full record lists 6 inclusion and 33 exclusion criteria; among the exclusions: laboratory tests meeting any of the following criteria at screening:; calcitonin ≥50ng/l (pg/ml);; blood amylase ≥3×uln (upper limit of normal value);.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
The Semaglutide group and the comparison group ran side by side rather than switching.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2024-04 with completion listed for 2025-08-30.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in HbA1c (time frame: Week 32).
It also tracked 9 secondary outcomes, for example Change in HbA1c, Change in FPG, Change in Body Weight, Change in Diastolic and Systolic Blood Pressure, Changes in Blood Lipids and Incidence and severity of Adverse Events.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 478 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.