A Randomized Controlled Trial of Once-Weekly Semaglutide for Limiting Post-Smoking Cessation Weight Gain in Adult Smokers With Overweight/Obesity
The University of Texas Health Science Center, Houston
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Ability to provide informed consent before any study-related activity, willing to comply with al study procedures, and be available for the duration of the study. * Body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension (unless meets medical exclusion criterion 7), cardiovascular disease (unless meets medical exclusion criterion 6), dyslipidemia, or obstructive sleep apnea * Have been smoking ≥5 cigarettes per day for at least 1 year (prior to screening) and provide…
Interventions
- Drugsemaglutide 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
- DrugPlacebo
Non-active medication, self-administered
- DrugNicotine 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.
- BehavioralBrief Smoking Cessation Counseling
Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.
Locations (2)
- The University of Texas at AustinAustin, Texas
- The University of Texas Health Science Center at HoustonHouston, Texas