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Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access
Plain-language guide to NCT07858331: phase 4 randomized trial of Semaglutide, 880 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07858331
- Phase
- phase 4
- Status
- not yet recruiting
- Start
- 2027-01-01
- Completion (planned or actual)
- 2029-01-01
- Participants
- 880 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Obesity; Chronic Kidney Disease; Chronic Renal Disease; CKD
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Semaglutide.
Obesity has a serious impact on people's health and quality of life.
It had two arms (groups): Virtual Weight Management Program (experimental) and Usual Care (no intervention).
Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.
The registry classes the interventions as behavioral and drug.
Who Took Part
The registry lists 880 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 18 years or older. BMI \>35 kg/m2.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: known contraindication to a glp-1ra (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding); type 1 diabetes.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 2027-01-01 with completion listed for 2029-01-01.
It ran at 2 sites in Canada (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in Body Weight (time frame: Baseline to 26 weeks +/- 14 days).
It also tracked 36 secondary outcomes, for example Quality of Life - Kidney Disease Quality of Life 36-Item Short Form, Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire, Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36), Body Mass Index (BMI), Body Surface Area (BSA) and Body Mass Index <35 kg/m².
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Semaglutide in 880 people.
With 880 participants it is a large trial for this field.
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.