NCT06173778

Semaglutide for Post-Smoking Cessation Weight Management

A Randomized Controlled Trial of Once-Weekly Semaglutide for Limiting Post-Smoking Cessation Weight Gain in Adult Smokers With Overweight/Obesity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This trial will examine the effect of semaglutide 2.4mg on changes in body weight, body composition, and peripheral and central mechanisms that control appetite, satiety, and food intake in the context of smoking cessation.

Conditions

• Obesity
• Overweight
• Cigarette Smoking

Interventions

Type	Name	Description
DRUG	semaglutide 2.4mg	Semaglutide 2.4mg will be self-administered once a week under the surface of the skin and will be started at 0.24mg once a week for 4 weeks; in 4-week intervals, the dose will be increased until a dose of 2.4mg is reached
DRUG	Placebo	Non-active medication, self-administered
DRUG	Nicotine Replacement Therapy (NRT, nicotine patch)	Participants who smoke \>10 cigarettes/day will use 21 mg patches for the first 6 weeks, 14 mg patches during weeks 7 and 8, and 7 mg patches during weeks 9 and 10. Participants who smoke 5-10 cigarettes per day will use 14 mg patches for the first 6 weeks and 7 mg patches for weeks 7-10.
BEHAVIORAL	Brief Smoking Cessation Counseling	Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.

Timeline

• Start date: 2024-04-23
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2023-12-18
• Last updated: 2026-02-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study