Semaglutide for Post-Smoking Cessation Weight Management
This study is looking at how semaglutide 2.4mg, a medication given once a week by injection under the skin, affects body weight and how your body controls appetite after you stop smoking. Participants will also receive nicotine replacement therapy (like patches) and weekly counseling to help them quit smoking. Some participants will receive a placebo (an inactive medication) instead of semaglutide. The study aims to understand changes in body weight from the start of the study to week 28. You may be able to join if you are between 18 and 75 years old, have a BMI of 30 or higher, or a BMI of 27 or higher with certain weight-related health conditions. The study plans to enroll 197 people.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 197 participants.
- What's involved
- Participants will self-administer semaglutide or placebo once a week, starting at a lower dose and gradually increasing. They will also use nicotine patches for 10 weeks and attend weekly individual smoking cessation counseling sessions.
- Compensation
- Not stated in the trial record.
- Follow-up
- Body weight changes will be measured from the beginning of the study until Week 28.
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NCT06173778
Semaglutide for Post-Smoking Cessation Weight Management
Recruiting
PHASE2Ages 18–75InterventionalTreatmentThe University of Texas Health Science Center, HoustonInvestigator-initiated
~197 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:semaglutide 2.4mgPlaceboNicotine Replacement Therapy (NRT, nicotine patch)Brief Smoking Cessation Counseling
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Body Weight Percent
Measured over Baseline to Week 28
Conditions
Where it's being run
2 sites across 1 statesTexas2
Study leadership
- Luba Yammine, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 positive cotinine test.
Desire to quit smoking (defined as "intend to quit within one month")
Agree (if the participant is female and of child-bearing potential) to use effective contraceptive methods, unless the participant's male partner(s) is surgically sterile (underwent vasectomy).
Women of child-bearing potential must provide negative urine pregnancy tests prior to randomization.
Normal cognitive restraint (assessed as cognitive restraint score of \<4 from the Three Factor Eating Habits Questionnaire)
Have a medical history and a brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the Study Physician and the Principal Investigator
Exclusion
Personal or first-degree relative(s) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Acute pancreatitis within the past 6 months prior to screening.
History or presence of chronic pancreatitis.
Type 1 or type 2 Diabetes Mellitus (previously diagnosed or indicated by HbA1C ≥48 mmol/mol (6.5%) as measured by central laboratory at screening).
End stage renal disease (ESRD, previously diagnosed or indicated by estimated glomerular filtration rate (eGFR) value of eGFR \< 15 ml/min/1.73 m2 as measured by central laboratory at screening).
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 60 days prior to screening.
Systolic blood pressure (SBP) \>159 mmHg and/or diastolic blood pressure (DBP) \>99 mmHg)
History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
Severe gastrointestinal disease (i.e., severe gastroparesis).
Known or suspected hypersensitivity to nicotine/nicotine patches; semaglutide, excipients, or related products.
Women who are currently pregnant, or plan to become pregnant, or lactating, or of childbearing potential and are not using medically accepted forms of contraception.
Have any illness or condition which in the opinion of the Principal Investigator and/or the Study Physician would preclude safe and/or successful completion of the study.
Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 3 months prior to screening (existing diagnosis or as determined by the structured interview).
Urine drug test positive, before randomization, for any of the following substances:
Psychotic or bipolar disorder, or mood disorder with psychotic features; or eating disorder (existing clinical diagnosis or as determined by the structured interview)
Moderate to high risk for suicidality (as determined by the structured interview).
Previously undergone bariatric surgery
Gained/lost ≥4.5 kg over the past 6 months (prior to screening)
Currently enrolled in a behavioral weight management plan
Uncontrolled thyroid disease (the criterion will be assessed at the Study Physician's and the Principal Investigator's discretion)
Currently using other combustible (e.g., cigars), other (e.g., chewing tobacco, snuff, snus) or alternative (e.g., electronic cigarettes) tobacco products
Currently using oral or injectable glucose lowering medications
Currently using pharmacotherapy for smoking cessation (NRT, varenicline, or bupropion)
Currently or recently (last 90 days prior to screening) taking medication used for weight management (i.e., orlistat, lorcaserin,vi naltrexone-bupropion, liraglutide, phentermine, topiramate, benzphetamine, diethylpropion, phendimetrazine)
Currently or recently (within the past 14 days prior to screening) taking medication(s) known to impact appetite and/or weight (i.e., corticosteroids, excluding inhaled)
Current, anticipated, or pending enrollment in another research study during this trial that could potentially affect participant safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician.
Not planning to live in the area for the duration of this trial.
Surgery scheduled for the duration of the trial, except for minor surgical procedures, in opinion of the Principal Investigator and/or the Study Physician.
Unable to communicate (read, write, and speak) fluently in English.
What this trial measures
- Change in Body Weight PercentBaseline to Week 28