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← All trials/NCT07059377

GLP1-SC

RecruitingPhase 3

Semaglutide for Smoking Cessation in Patients With Diabetes

Semaglutide for Smoking Cessation in Patients With Diabetes: A Pilot Randomized Controlled Trial

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Estimated enrollment

100

Study population

Alcohol / substance use, Type 2 diabetes

Eligibility highlights

•HbA1c 7-10%

Primary endpoint

•Project success

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07059377
Org study IDHM74061

Timeline

Milestones

Study first posted2025-07-10actual
Study start2026-02-13actual
Last update posted2026-05-11actual
Primary completion2026-07estimated (month precision)
Study completion2027-07estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Alcohol / substance useType 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot 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).

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
3
Glycemic / diabetes
1
Other clinical outcomes
1
Other (unclassified)
1

Weight & body composition

3 endpoints
Secondary/protocol endpoint/low confidence

Height

Time frame:6, and 12 months

change from baseline, descriptive

Secondary/protocol endpoint

Weight

Time frame:6, and 12 months

descriptive, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:6, and 12 months

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Blood glucose score

Time frame:6, and 12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Smoking status

Time frame:6 months

categorical status, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Project success

Time frame:12 months

ratio, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.