A Phase 4 interventional study of Semaglutide and Virtual Weight Management Coaching in Obesity and Chronic Kidney Disease, sponsored by Western University, Canada. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Western University, Canada · Phase 4, Interventional, and Other
OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial.
We will randomize participants with obesity, high-risk CKD/dialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.
Obesity is well-recognized as an independent risk factor for chronic kidney disease (CKD) including end-staged kidney disease (ESKD). In people with ESKD, obesity can preclude access to lifesaving kidney transplantation. Of solid organ transplant programs in Canada, 80% exclude people with obesity (based upon body mass index or BMI), due to a potential risk of perioperative complications and post-transplant mortality.
Losing weight for kidney transplantation can, however, be extremely difficult. Medications that can promote weight loss in other populations including glucagon-like peptide 1 receptor agonists (GLP-1RA; liraglutide, semaglutide, and dulaglutide) and glucose-dependent insulinotropic polypeptide (GIP-1RA)/GLP-1RAs (tirzepatide), have not been studied in devoted trials of advanced CKD participants, and their efficacy and safety remain unclear.
Nutritional advice is often very difficult to follow when trying to balance kidney and diabetes diets (e.g. potassium), and if diets are too restrictive, there may be protein-energy wasting which could be detrimental to patients. People with high-risk CKD frequently live with functional impairment which can limit exercise. Weight loss programs can be cost prohibitive to those who are already socioeconomically disadvantaged.
A vanguard is needed before a large, multicentered RCT: A feasibility study will allow us to ensure that we can recruit a sufficient sample of participants into our trial, that our trial processes are inclusive, and that they are acceptable to patients. In the vanguard phase of our trial, we will answer the following questions:
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Western University, Canada is the lead sponsor of 221 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A maximum tolerated dose of semaglutide (Ozempic/Wegovy) will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months.
Drug: Semaglutide · Behavioral: Virtual Weight Management Coaching
Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.
Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.
Also known as: GLP-1RA, Ozempic, Wegovy
Virtual meeting with intervention coach once every 4 weeks for 6 months, where the coach will discuss the goals and progress with participant, nutritional advice, exercise advice, and motivational support.
Feasibility of Recruitment
Number of participants enrolled across three centers, with success defined as recruitment of ≥ 60 participants within the 12-month enrollment period.
Time frame: 12 months
Adherence to Scheduled Coaching Visits
Percentage of participants randomized to the intervention attend \>75% of their scheduled coaching visits.
Time frame: 12 months
Adherence to GLP-1RA Therapy
Percentage of participants randomized to the intervention fill \>75% of their semaglutide prescriptions.
Time frame: 12 months
Recruitment of ≥20 Participants in First 12 Weeks
Recruitment of ≥20 participants in first 12 Weeks of trial initiation
Time frame: First 12 weeks
Recruitment Per Site Within 12 Weeks
At least one participant recruited per site within 12 weeks of trial initiation each active site
Time frame: First 12 weeks
Incidence of Acute Kidney Injury
Number of participants experiencing acute kidney injury (AKI)
Time frame: 12 months
Incidence of Hypoglycemia
Number of participants experiencing hypoglycemia
Time frame: 12 months
Incidence of Gastrointestinal Side Effects
Number of participants experiencing GI side effects
Time frame: 12 months
Change in Dalhousie Clinical Frailty Scale Classification
Change in participant's Dalhousie Clinical Frailty Scale Classification from baseline to 26 weeks. The scale has 9 options, from 1 (very fit) to 9 (terminally ill).
Time frame: 26 weeks
Change in SARC-F Score of Sarcopenia
Change in participant's SARC-F questionnaire score from baseline to 26 weeks. Out of 8 points, a SARC-F score of ≥4 best predicts the need for further, more comprehensive clinical evaluation.
Time frame: 26 weeks
Change in Body Weight - Smart Scale
Change in weight from baseline to 26 weeks, measured in kilograms. Measured using a Smart Scale in a subpopulation.
Time frame: 26 weeks
Change in Body Fat - Smart Scale
Change in body fat from baseline to 26 weeks, measured in percentage. Measured using Smart Scale in subpopulation.
Time frame: 26 weeks
Change in Muscle Mass - Smart Scale
Change in muscle mass from baseline to 26 weeks. Measured in kilograms. Measured using Smart Scale in subpopulation.
Time frame: 26 weeks
Change in Body Water Content - Smart Scale
Change in body water content from baseline to 26 weeks. Measured in percentage. Measured using Smart Scale in subpopulation.
Time frame: 26 weeks
In-Clinic Height Measurement
In-clinic height measurements, measured in centimeters
Time frame: Baseline, 3 months, 6 months
In-Clinic Weight Measurement
In-clinic weight measurements, measured in kilograms
Time frame: Baseline, 3 months, 6 months
In-Clinic Body Mass Index Measurement
In-clinic BMI measurements, measured in kg/m\^2
Time frame: Baseline, 3 months, 6 months
Percentage of Change in HbA1c
Percentage of change in HbA1c from baseline to 26 weeks, measured in percentage
Time frame: 26 weeks
Change in 2-week glycemic variability
For those using a Libre or Continuous Glucose Monitoring at baseline, Percentage of change in 2-week glycemic variability from baseline to 26 weeks
Time frame: 26 weeks
Change in Time-in-Range
For those using a Libre or Continuous Glucose Monitoring at baseline, Percentage of change in Time-in-Range from baseline to 26 weeks
Time frame: 26 weeks
Plan to share: Yes — Demographics (age, sex, etc.) Baseline characteristics Lab Values Outcome Measurements Adverse event data Other data points collected for each participant
Supporting information: Study protocol, Sap
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Western University, Canada