NCT07059377

Semaglutide for Smoking Cessation in Patients With Diabetes

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Smoking and diabetes are well-established risk factors for cardiovascular disease (CVD) and leading causes of global morbidity and mortality. Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are primarily known for their role in managing diabetes, where they have demonstrated tremendous benefits in glucose control and weight loss. Approximately 12% of adults in the U.S. have ever taken a GLP-1 RA, with 6% currently using these medications. Beyond their primary focus, emerging evidence shows improved clinical outcomes such as Major Adverse Cardiovascular Events (MACE) and Obstructive Sleep Apnea (OSA). Recent research explores the potential role of GLP-1 RA in nicotine addiction. These medications suppress nicotine-induced dopamine release in the nucleus, which supports the exploration of GLP-1 RA therapies for nicotine dependence. Additionally, GLP-1 RA stimulates insulin secretion and reduces energy intake, addressing the common concern of post-cessation weight gain. While GLP-1 RA have been extensively studied for their effects on weight management, their impact on smoking cessation has only been investigated in a limited number of trials. 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. We 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). Research question - Among individuals living with diabetes who smoke, does the addition of GLP-1 RA to combination NRT result in increased smoking cessation at 6-month follow-up?

Conditions

• Diabetes Mellitus, Type 2
• Nicotine Addiction
• Tobacco Dependence

Interventions

Type	Name	Description
DRUG	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
DRUG	Nicotine replacement	Nicotine patch plus short-acting NRT gum or lozenge

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2025-07-10
• Last updated: 2025-08-22