Recruiting

Obesity Management

Sponsor:

Western University, Canada

Code:

NCT06396416

Conditions

Obesity

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Virtual Weight Management Coaching

Study Details

Brief summary:

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.

Conditions

Obesity

Chronic Kidney Disease

Study ID

NCT06396416

Start date

Sep 26, 2024

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults aged 18 years or older
  • BMI; 35 kg/m\^2
  • 10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis

Exclusion Criteria:

  • Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity)
  • Type 1 diabetes
  • No access to semaglutide via drug coverage
  • Pregnant, breastfeeding or planning to become pregnant
  • Currently in a GLP-1RA or GLP-1RA/GIP study or planning to be in one

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Virtual Weight Management Program

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.

no intervention: Usual Care

Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

Interventions

Semaglutide

Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.

Virtual Weight Management Coaching

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.

Primary outcome measure

  • Feasibility of Recruitment [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Heather LaPier, BSc

519-646-6100heather.lapier@sjhc.london.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Heather LaPier, BSc

519-646-6100heather.lapier@sjhc.london.on.ca

Principal Investigator:

Louise Moist, MD

More Information

Sponsor

Western University, Canada

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Weight Management
  • Transplant
  • GLP-1RA
  • Pilot Study
  • Registries
  • Pragmatic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Western University, Canada on 2026-06-29.