Recruiting
Phase 3

Semaglutide with NRT

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT07059377

Conditions

Diabetes Mellitus, Type 2

Nicotine Addiction

Tobacco Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Nicotine replacement

Study Details

Brief summary:

To assess the feasibility of conducting a randomized controlled trial (RCT) to determine the effectiveness of semaglutide as an adjunct to combination NRT in supporting smoking cessation for patients with diabetes.

Conditions

Diabetes Mellitus, Type 2

Nicotine Addiction

Tobacco Dependence

Study ID

NCT07059377

Start date

Feb 13, 2026

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (18 years or older) with type 2 diabetes
  • Currently residing in Ontario
  • Smoke at least five cigarettes per day and willing to reduce or quit smoking within the next 6 months
  • Stable HbA1c ≥7.0% - 10% with no more than a 1% change over the last 3 to 6 months.
  • Have not used GLP-1 receptor agonists in the past six months.
  • Able to provide informed consent

Exclusion Criteria:

  • Pregnant or breastfeeding individuals
  • Contraindication to NRT or GLP-1 RA.
  • Current daily use of NRT or a GLP1 RA.
  • Use of bupropion, cytisine, and varenicline within the last 7 days.
  • Use of a DPP-IV inhibitor within the last 7 days.
  • Initiation of a new diabetes medication within the last 3 months.
  • As per the product monograph, participants with the following diagnoses or disorders will be excluded;
  • Personal or family history of medullary thyroid cancer
  • Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
  • Diabetic ketoacidosis
  • Type I diabetes
  • Acute pancreatitis or pancreatic cancer
  • Acute, chronic or end-stage renal failure
  • Tachyarrhythmias
  • Unable to engage in follow-up for any reason (for example an acute mental illness, cognitive impairment, unable to speak English or French).
  • Other conditions deemed by the study team to interfere with participation or outcomes in the opinion of the study investigator (for example acutely unwell, life expectancy less than 1 year).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Semaglutide + Combination NRT for up to 6 months

active comparator: Control

Combination NRT for up to 6 months

Interventions

Semaglutide

Starting dose will be 0.25mg once a week for 4 weeks, then titrated up to 0.5mg once a week. For those requiring additional blood sugar control, the dose may be titrated up to the maximum dose of 2mg once a week. All participants will use this medication for up to 26 weeks

Nicotine replacement

Nicotine patch plus short-acting NRT gum or lozenge

Primary outcome measure

  • Project success [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Evyanne Quirouette

613-696-7000equirouette@ottawaheart.ca

Nidhi Agrawal

613-696-7000NAgrawal@ottawaheart.ca

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Nidhi Agarwal

613-696-7000Nagrawal@ottawaheart.ca

Principal Investigator:

Hassan Mir, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Sep 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-09-08.