Recruiting

Semaglutide

Sponsor:

Unity Health Toronto

Code:

NCT07017270

Conditions

Kidney Disease, Chronic

Diabetes

Dialysis

End Stage Kidney Disease (ESRD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide Pen

Study Details

Brief summary:

This study aims to determine if GLP1RA is safe and tolerable in maintenance dialysis population, adherence, and feasibility of a larger definitive cardiovascular outcome trial in this population. Participants will be randomized 1:1 to either weekly subcutaneous semaglutide versus usual care and followed for 26 weeks.

Conditions

Kidney Disease, Chronic

Diabetes

Dialysis

End Stage Kidney Disease (ESRD)

Study ID

NCT07017270

Start date

Nov 27, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18
2. Receiving chronic maintenance hemodialysis or peritoneal dialysis for ≥ 90 days
3. confirmed DM2 based on medical history and current or prior receipt of an oral hypoglycemic agent and/or insulin.
4. Ability to provided informed consent or through their substitute decision maker

Exclusion Criteria:

1. Type 1 DM
2. Use of a GLP-1-RA within 30 days prior to screening
3. Personal or first-degree relative(s) with a history of type 2 multiple endocrine neoplasia syndrome or medullary thyroid cancer, or acute pancreatitis (within 180 days of study screening)
4. Confirmed pregnancy, women of childbearing potential
5. Known hypersensitivity to GLP-1-RA
6. Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transplantation within 6 months
7. Enrolment in another clinical trial judged by the investigator to interact with the effect of GLP1-RA

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual Care Group

This treatment arm comprises a strategy of usual care for type 2 diabetes mellitus

experimental: Semaglutide

Individuals randomized to this arm will take semaglutide once weekly.

Interventions

Semaglutide Pen

Individuals randomized to this arm will take semaglutide once weekly. For participants receiving in-centre hemodialysis, the intervention may be administered during the dialysis session by nursing personnel based on the patient's preference.

Primary outcome measure

  • Adherence of Study Intervention [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Locations

Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B1W8

Contacts

More Information

Sponsor

Unity Health Toronto

Last update posted

Jun 26, 2026

Last verified

Mar, 2026

Keywords

  • Dialysis
  • Type 2 diabetes
  • semaglutide
  • end stage kidney disease
  • GLP1
  • GLP1RA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-06-26.