NCT06986993

Impact of Semaglutide on Tobacco Use and Related Health Behaviors

Impact of Semaglutide Administration on Tobacco Use Behavior and Related Mechanisms Among Smokers With Obesity

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This pilot randomized trial will assess the impact of 12 weeks of semaglutide administration (vs placebo) on changes in: (i) tobacco use and related factors (nicotine craving, withdrawal, motivation to quit, etc.) and (ii) biological biomarkers of health (e.g., epigenetics, glucose variability via continuous glucose monitoring \[CGM\], etc.) in adult smokers with obesity (n = 40). We will integrate molecular biology procedures (e.g., epigenetics) to maximize internal validity with real-world smartphone-based ecological momentary assessment (EMA) surveys to maximize external validity

Conditions

• Tobacco Use

Interventions

Type	Name	Description
DRUG	Semaglutide	Participants are randomized to receive either semaglutide or placebo (saline) via sc injection once a week for 12 weeks. Dose will be titrated per recommendations every 4 weeks,starting at .25mg, then 0.5mg and then 1.0mg
DRUG	Placebo	Participants are randomized to receive either semaglutide or placebo (saline) via sc injection once a week for 12 weeks. Dose will be titrated per recommendations every 4 weeks,starting at .25mg, then 0.5mg and then 1.0mg

Timeline

• Start date: 2024-07-01
• Primary completion: 2028-05-30
• Completion: 2028-06-30
• First posted: 2025-05-23
• Last updated: 2025-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study