ObesityPhase 4PIVOTNCT07858331
Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access
A Phase 4 study testing Semaglutide and Virtual Weight Management Coaching in people with Obesity and Chronic Kidney Disease, run by Kristin Clemens at 2 sites in Canada.
Trial summary
Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Chronic Kidney Disease, Chronic Renal Disease
- What is being tested?
- Semaglutide and Virtual Weight Management Coaching
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2027to 1 Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- BMI >35 kg/m2
- eGFR <15ml/min/1.73m2 at baseline OR 2-year KFRE2 of 10% or greater
Who cannot join
- Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding)
- Type 1 diabetes
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
St. Joseph's Health Care
London, Ontario, N6A4V2
Heather LaPier, 519-646-6100 ext. 65373, heather.lapier@sjhc.london.on.ca
London Health Sciences Centre
London, Ontario
Heather LaPier, MD, 519-646-6100 ext. 65373, heather.lapier@sjhc.london.on.ca
About this study
Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a lifesaving kidney transplantation due to concerns about operation risks. Unfortunately, there is an urgent need but no rigorously proven treatments to help people with advanced kidney disease lose weight effectively and safely.
The investigative team is a large team of doctors, nurses, dieticians, exercise specialists, social scientists, and patients with a lived experience, have spent three years advancing research to help people with advanced kidney disease achieve a healthier body weight. They have created a special weight loss program that combines individualized coaching on diet and save activity with a medication proven to help people with healthier kidneys lose weight (i.e. Ozempic). This research program is called PIVOT: Patient-centred Intervention with Virtual support for Obesity and kidney Transplant access.
The investigators have started to test PIVOT in a small pilot study and early results show that there is potential to study the program on a much larger scale (i.e. across Canada). With funding from CIHR, the investigators aim to reach more Canadians with advanced kidney disease (including people of lower income, women, and people of different races) with an aim of helping them lose weight safely, feel better, obtain a kidney transplant, and staying healthier over the longer term.
- Conditions
- Obesity, Chronic Kidney Disease, Chronic Renal Disease, CKD
- Being tested
- Semaglutide, Virtual Weight Management Coaching
- Medical subject headings
- Obesity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Wegovy, Ozempic, Generic Semaglutide, Apo-Semaglutide
Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.
Virtual Weight Management CoachingBehavioural
Also called Coaching, Weight Management
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Weight Management Program | Experimental | A maximum tolerated dose of semaglutide 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. Receives: Drug: Semaglutide; Behavioral: Virtual Weight Management Coaching |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Continuous measure of weight in kilograms assessed on calibrated clinic scales (dry weight for those receiving dialysis given fluid shifts)
Measured: Baseline to 26 weeks +/- 14 days
Secondary outcomes (36)
Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
Change in Kidney Disease Quality of Life (KDQOL-36) score across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life.
Measured: Baseline to 26 weeks +/- 14 days
Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire
Change in health-related quality of life measured using the European Quality of Life 5-Dimension, 5-Level questionnaire across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst).
Measured: Baseline to 26 weeks +/- 14 days
Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)
Change in functional status measured with KDQOL-36™ scores across treatment arms. KDQOL-36 is scored on a 0-100 scale across five domains, with higher scores indicating better health-related quality of life.
Measured: Baseline to 26 weeks +/- 14 days
Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.
Measured via EQ-5D-5L (European Quality of Life five-dimensional, five-level generic measure) scores across treatment arms. A score of 11111 = no problems in any dimension (best), and a score of 55555 = extreme problems in all dimensions (worst).
Measured: Baseline to 26 weeks +/- 14 days
Weight Loss ≥5%
Percentage of participants achieving at least 5% reduction in body weight from baseline.
Measured: Baseline to 26 weeks +/- 14 days
Weight Loss ≥10%
Percentage of participant achieving at least 10% reduction in body weight from baseline.
Measured: Baseline to 26 weeks +/- 14 days
Weight Loss ≥15%
Percentage of participants achieving at least 15% reduction in body weight from baseline.
Measured: 26 weeks +/- 14 days
Weight Loss ≥20%
Percentage of participants achieving at least 20% reduction in body weight from baseline.
Measured: Baseline to 26 weeks +/- 14 days
Body Mass Index (BMI)
Change in BMI across treatment arms. Measured in kg/m²
Measured: Baseline to 26 weeks +/- 14 days
Body Surface Area (BSA)
Change in BSA across treatment arms. Measured in m².
Measured: Baseline to 26 weeks +/- 14 days
Body Mass Index <35 kg/m²
Percentage of participants achieving a BMI below <35 kg/m², corresponding to the specified weight-based threshold for transplant listing.
Measured: Week 26 +/- 14 days
Dalhousie Clinical Frailty Scale Rating
Change in Dalhousie Clinical Frailty Scale rating across treatment arms. The scale ranges from 1 (very fit) to 9 (terminally ill).
Measured: Baseline to 26 weeks +/- 14 days
SARC-F Score
Change in sarcopenia measured by SARC-F score across treatment arms. This questionnaire is scored out of 10, with a score of 4 or higher indicating probable sarcopenia.
Measured: Baseline to 26 weeks +/- 14 days
FRAIL Scale
Change in frailty measured by the FRAIL Scale across treatment arms. The scale scores five components - fatigue, resistance, ambulation, illnesses, and loss of weight - on a 0-5 scale, with 0 indicating robust, 1-2 pre-frail, and 3 or more indicating frailty.
Measured: Baseline to 26 weeks +/- 14 days
Acute Kidney Injury (AKI)
Incidence of AKI. AKI defined by KDIGO as creatinine ≥ 1.5x baseline within 7 days in non-dialysis participants
Measured: Baseline to 26 weeks +/- 14 days
Hypoglycemia
Incidence of hypoglycemia (blood glucose <4 mmol/L or time below target using continuous glucose monitoring)
Measured: Baseline to week 26 +/- 14 days
Gastrointestinal Symptoms
Incidence of gastrointestinal symptoms, including nausea, vomiting, constipation
Measured: Baseline to 26 weeks +/- 14 days
Acute Biliary Disease
Incidence of acute biliary disease.
Measured: Baseline to 26 weeks +/- 14 days
Acute Pancreatitis
Incidence of acute pancreatitis.
Measured: Baseline to 26 weeks +/- 14 days
Diabetic Retinopathy Interventions
Incidence of interventions for diabetic retinopathy
Measured: Baseline to 26 weeks +/- 14 days
Injection-site reactions
Incidence of injection-site reactions in the intervention arm.
Measured: Baseline to 26 weeks +/- 14 days
Malignant Neoplasms
Incidence of malignant neoplasms.
Measured: Baseline to 26 weeks +/- 14 days
Coaching Visit Adherence
Percentage of participants completing ≥4 of 6 coaching visits.
Measured: Baseline to 26 weeks +/- 14 days
Semaglutide Discontinuation
Percentage of participants discontinuing semaglutide in the intervention arm.
Measured: Baseline to 26 weeks +/- 14 days
Achievement of semaglutide dose ≥1.0 mg/week
Percentage of participants in the intervention group achieving a semaglutide dose of ≥1.0 mg/week.
Measured: Week 26 +/- 14 days
Achievement of Semaglutide Dose ≥2.0 mg/week
Percentage of participants achieving a semaglutide dose of ≥2.0 mg/week
Measured: 26 weeks +/- 14 days
Semaglutide Initiation in Usual Care
Percentage of usual care arm participants initiating semaglutide during the study period.
Measured: Baseline to 26 weeks +/- 14 days
Use of Semaglutide in Usual Care Participants
Percentage of participants using semaglutide in the usual care arm.
Measured: Baseline to 26 weeks +/- 14 days
Semaglutide Dose ≥1.0 mg/Week in Usual care Arm
Percentage of usual care participants achieving semaglutide dose ≥1.0 mg/week
Measured: 26 weeks +/- 14 days
Semaglutide Dose ≥2.0 mg/Week in Usual Care Arm
Percentage of usual care participants achieving semaglutide dose ≥2.0 mg/week
Measured: 26 Weeks +/- 14 days
Body Fat Percentage Measured with Smart Scale
Change in body fat percentage among the subsample of intervention participants using the study smart scale.
Measured: Baseline to 26 weeks +/- 14 days
Muscle Mass Measured with Smart Scale
Measured in kilograms. Change in muscle mass among the subsample of intervention participants using the study smart scale.
Measured: Baseline to 26 weeks +/- 14 days
Intervention Costs
The total cost of the intervention incurred by participants during the 26-week follow-up period, in Canadian dollars (CAD)
Measured: Baseline to 26 weeks
Out-of-pocket costs
Total out-of-pocket costs incurred by participants during the 26-week study period-including costs directly related to the intervention. Measured in Canadian dollars (CAD)
Measured: Baseline to 26 weeks
Lost Productivity Costs
Costs associated with productivity losses during the 26-week follow-up period, including costs directly related to the participant's health care and intervention. Measured in Canadian dollars (CAD)
Measured: Baseline to 26 weeks
Health care utilization costs
Total costs associated with health care utilization during the study period, including physician visits, hospitalizations, emergency department visits, medications, allied health services. Measured in Canadian dollars (CAD) using provincial administrative health data.
Measured: Baseline to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kristin Clemens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristin Clemens, Western University, Canada
- Investigators
- Kristin Clemens, MD, Principal investigator, St. Joseph's Health Care London, Western UniversityLouise Moist, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858331
- Sponsor's protocol ID
- PIVOT
- Acronym
- PIVOT
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access
- ClinicalTrials.gov ID
- NCT07858331
- Acronym / sponsor ID
- PIVOT / PIVOT
- Conditions
- Obesity, Chronic Kidney Disease, Chronic Renal Disease, CKD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Kristin ClemensUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity has a serious impact on people's health and quality of life. For those with advanced kidney disease (i.e. approaching the need for dialysis), obesity is especially problematic - obesity can not only lead to worsening kidney function and kidney failure, but it can also prevent patients from receiving a lifesaving kidney transplantation due to concerns about operation risks. Unfortunately, there is an urgent need but no rigorously proven treatments to help people with advanced kidney disease lose weight effectively and safely.
The investigative team is a large team of doctors, nurses, dieticians, exercise specialists, social scientists, and patients with a lived experience, have spent three years advancing research to help people with advanced kidney disease achieve a healthier body weight. They have created a special weight loss program that combines individualized coaching on diet and save activity with a medication proven to help people with healthier kidneys lose weight (i.e. Ozempic). This research program is called PIVOT: Patient-centred Intervention with Virtual support for Obesity and kidney Transplant access.
The investigators have started to test PIVOT in a small pilot study and early results show that there is potential to study the program on a much larger scale (i.e. across Canada). With funding from CIHR, the investigators aim to reach more Canadians with advanced kidney disease (including people of lower income, women, and people of different races) with an aim of helping them lose weight safely, feel better, obtain a kidney transplant, and staying healthier over the longer term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Weight Management Program | Experimental | Drug: Semaglutide, Behavioral: Virtual Weight Management CoachingA maximum tolerated dose of semaglutide 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- BMI >35 kg/m2
- eGFR <15ml/min/1.73m2 at baseline OR 2-year KFRE2 of 10% or greater
Key exclusion criteria (2 listed)
- Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity, pregnancy, breastfeeding)
- Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: Wegovy, Ozempic, Generic Semaglutide, Apo-SemaglutideMaximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg. | Drug | Virtual Weight Management Program |
| Virtual Weight Management CoachingAlso: Coaching, Weight ManagementVirtual 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. | Behavioural | Virtual Weight Management Program |
Primary outcome
Change in Body Weight
Time frame: Baseline to 26 weeks +/- 14 days
Continuous measure of weight in kilograms assessed on calibrated clinic scales (dry weight for those receiving dialysis given fluid shifts)
36 secondary outcomes
Quality of Life - Kidney Disease Quality of Life 36-Item Short Form
Time frame: Baseline to 26 weeks +/- 14 days
Health-Related Quality of Life - European Quality of Life 5 Dimensions, 5 Level (EQ-5D-5L) Questionnaire
Time frame: Baseline to 26 weeks +/- 14 days
Change in Functional Status - Kidney Disease Quality of Life 36-Item Short form (KDQOL-36)
Time frame: Baseline to 26 weeks +/- 14 days
Change in Functional Status - European Quality of Life five-dimensional, five-level generic measure (EQ-5D-5L) scores across treatment arms.
Time frame: Baseline to 26 weeks +/- 14 days
Weight Loss ≥5%
Time frame: Baseline to 26 weeks +/- 14 days
Weight Loss ≥10%
Time frame: Baseline to 26 weeks +/- 14 days
Weight Loss ≥15%
Time frame: 26 weeks +/- 14 days
Weight Loss ≥20%
Time frame: Baseline to 26 weeks +/- 14 days
Body Mass Index (BMI)
Time frame: Baseline to 26 weeks +/- 14 days
Body Surface Area (BSA)
Time frame: Baseline to 26 weeks +/- 14 days
Body Mass Index <35 kg/m²
Time frame: Week 26 +/- 14 days
Dalhousie Clinical Frailty Scale Rating
Time frame: Baseline to 26 weeks +/- 14 days
SARC-F Score
Time frame: Baseline to 26 weeks +/- 14 days
FRAIL Scale
Time frame: Baseline to 26 weeks +/- 14 days
Acute Kidney Injury (AKI)
Time frame: Baseline to 26 weeks +/- 14 days
Hypoglycemia
Time frame: Baseline to week 26 +/- 14 days
Gastrointestinal Symptoms
Time frame: Baseline to 26 weeks +/- 14 days
Acute Biliary Disease
Time frame: Baseline to 26 weeks +/- 14 days
Acute Pancreatitis
Time frame: Baseline to 26 weeks +/- 14 days
Diabetic Retinopathy Interventions
Time frame: Baseline to 26 weeks +/- 14 days
Injection-site reactions
Time frame: Baseline to 26 weeks +/- 14 days
Malignant Neoplasms
Time frame: Baseline to 26 weeks +/- 14 days
Coaching Visit Adherence
Time frame: Baseline to 26 weeks +/- 14 days
Semaglutide Discontinuation
Time frame: Baseline to 26 weeks +/- 14 days
Achievement of semaglutide dose ≥1.0 mg/week
Time frame: Week 26 +/- 14 days
Achievement of Semaglutide Dose ≥2.0 mg/week
Time frame: 26 weeks +/- 14 days
Semaglutide Initiation in Usual Care
Time frame: Baseline to 26 weeks +/- 14 days
Use of Semaglutide in Usual Care Participants
Time frame: Baseline to 26 weeks +/- 14 days
Semaglutide Dose ≥1.0 mg/Week in Usual care Arm
Time frame: 26 weeks +/- 14 days
Semaglutide Dose ≥2.0 mg/Week in Usual Care Arm
Time frame: 26 Weeks +/- 14 days
Body Fat Percentage Measured with Smart Scale
Time frame: Baseline to 26 weeks +/- 14 days
Muscle Mass Measured with Smart Scale
Time frame: Baseline to 26 weeks +/- 14 days
Intervention Costs
Time frame: Baseline to 26 weeks
Out-of-pocket costs
Time frame: Baseline to 26 weeks
Lost Productivity Costs
Time frame: Baseline to 26 weeks
Health care utilization costs
Time frame: Baseline to 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Clemens, MD principal investigator
St. Joseph's Health Care London, Western University
Louise Moist, MD principal investigator
London Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide and Virtual Weight Management Coaching in people with Obesity and Chronic Kidney Disease, run by Kristin Clemens at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather LaPier (519-646-6100 ext. 65373, heather.lapier@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline to 26 weeks +/- 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.