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Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)
Plain-language guide to NCT06959784: phase 4 randomized trial of Semaglutide, 142 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06959784
- Phase
- phase 4
- Status
- enrolling by invitation
- Start
- 2024-01-01
- Completion (planned or actual)
- 2026-12-31
- Participants
- 142 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus; Cardiovascular Diseases; Cerebrovascular Disease
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Semaglutide.
It had two arms (groups): Metformin control group (placebo comparator) and semaglutide group (experimental).
The registry classes the interventions as drug.
Who Took Part
142 planned participants were the target.
It was open to people of any sex aged from 30 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Newly diagnosed diabetes, with no previous use of hypoglycemic medications or having discontinued such medications for more than 3 months. Age between 30 and 70 years (inclusive of boundary values). BMI between 24 and 32.5 kg/m² (inclusive of boundary values).
The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: history of coronary heart disease or cerebral infarction; history of malignant tumors; use of systemic glucocorticoids (excluding local applications or inhalants) for one week or more within the three months prior to screening.
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.
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 2024-01-01 with completion listed for 2026-12-31.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Cardiovascular and cerebrovascular event risk score (time frame: One-year follow-up). Major Adverse Cardiovascular Events (time frame: Baseline and every 12 weeks until 96 weeks). Cerebrovascular disease events (time frame: Baseline and every 12 weeks until 96 weeks).
It also tracked 14 secondary outcomes, for example The remission rate of diabetes, Glycated hemoglobin, Fasting and postprandial blood glucose levels, pancreatic islet function, Heart rate and Carotid artery peak systolic velocity.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Semaglutide in 142 people.
Its status is enrolling by invitation; 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.