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A Study of BGM0504 in Chinese Patients With Type 2 Diabetes
Plain-language guide to NCT06974825: phase 2 randomized trial of Semaglutide, 67 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06974825
- Phase
- phase 2
- Status
- completed
- Start
- 2023-08-30
- Completion (planned or actual)
- 2024-08-13
- Participants
- 67 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Semaglutide.
It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 67 actual participants took part.
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: Have been diagnosed with type 2 diabetes mellitus (T2DM);. Body Mass Index (BMI): 19.5 kg/m2 ≤ BMI ≤ 35.0 kg/m2;.
The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: diagnosed with non-type 2 diabetes mellitus;; grade 3 hypoglycemia within 6 months prior to screening;; patients with a previous history or clinical evidence of acute or chronic pancreatitis;.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
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 2023-08-30 with completion listed for 2024-08-13.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Week 0 to Week 12).
It also tracked 4 secondary outcomes, for example Change From Baseline in Body Weight and Change From Baseline in Fasting Serum Glucose.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Semaglutide in 67 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.