Semaglutide for Smoking Cessation in Patients With Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

It had two arms (groups): Intervention (experimental) and Control (active comparator).

Semaglutide + Combination NRT for up to 6 months.

Combination NRT for up to 6 months.

The registry classes the interventions as drug.

More on the Plan

Smoking and diabetes are well-established risk factors for cardiovascular disease (CVD) and leading causes of global morbidity and mortality.

These medications suppress nicotine-induced dopamine release in the nucleus, which supports the exploration of GLP-1 RA therapies for nicotine dependence.

High-quality evidence is needed using newer and more commonly used GLP-1 RA to assess their effect on smoking cessation and mitigating post-cessation weight gain.

The researchers plan to conduct a definitive RCT but need a pilot study to determine feasibility of recruitment, treatment adherence, attrition, and to provide a preliminary estimate of effect size (for sample size calculation).

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults (18 years or older) with type 2 diabetes. Currently residing in Ontario. Have not used GLP-1 receptor agonists in the past six months. Able to provide informed consent.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: pregnant or breastfeeding individuals; contraindication to nrt or glp-1 ra; current daily use of nrt or a glp1 ra.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-02-13 with completion listed for 2026-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Project success (time frame: 12 months).

It also tracked 5 secondary outcomes, for example Smoking status, Blood glucose score, Height, Weight and Waist circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.