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Phase III Clinical Study on the Efficacy and Safety of Semaglutide and Ozempic® in Patients With Type 2 Diabetes
Plain-language guide to NCT07046273: phase 3 randomized trial of Semaglutide, 496 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07046273
- Phase
- phase 3
- Status
- not yet recruiting
- Start
- 2025-08-01
- Completion (planned or actual)
- 2028-08-01
- Participants
- 496 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes (T2DM)
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Semaglutide.
It had two arms (groups): F027 (experimental) and Ozempic® (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 496 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.
The full record lists 1 inclusion and 26 exclusion criteria; among the exclusions: type 1 diabetes, special type of diabetes;; received hypoglycemic drugs other than metformin (including chinese medicine) within 8 weeks before randomization;; has a history of ≥2 episodes of grade 3 hypoglycemia within 1 year before randomization;.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
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 2025-08-01 with completion listed for 2028-08-01.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in HbA1c from baseline (time frame: Week 32).
It also tracked 9 secondary outcomes, for example Change in HbA1c from baseline, Change in Fasting Glucose, Change in Body Weight, Incidence of hypoglycemic events and acute pancreatitis, Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (Nab) and Semaglutide steady-state trough concentration (Css, min).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 496 people.
Its status is not yet recruiting; 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.