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A Study of BGM0504 in Participants With Type 2 Diabetes
Plain-language guide to NCT06716216: phase 3 randomized trial of Semaglutide, 537 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06716216
- Phase
- phase 3
- Status
- active, not recruiting
- Start
- 2025-01-13
- Completion (planned or actual)
- 2026-11-14
- Participants
- 537 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus (T2DM)
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Semaglutide.
This trial is conducted in China.
It had three arms (groups): one (experimental), one (experimental) and one (active comparator).
Drug: BGM0504 Administered SC.
Drug: BGM0504 Administered SC.
Drug: Semaglutide Administered SC.
The registry classes the interventions as drug.
Who Took Part
537 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: ■ Have been diagnosed with type 2 diabetes mellitus (T2DM);. Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;.
The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: ■ previous diagnosis of type 1 diabetes, special type diabetes;; have had chronic or acute pancreatitis any time prior to study entry;; mentally incapacitated or speech-impaired;.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
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 2025-01-13 with completion listed for 2026-11-14.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Week 0 to Week 32).
It also tracked 5 secondary outcomes, for example Change From Baseline in Body Weight, Change From Baseline in Hemoglobin A1c (HbA1c) and Change From Baseline in Fasting Serum Glucose.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 537 people.
With 537 participants it is a large trial for this field.
Its status is active not 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.