Weight-Loss drug semaglutide may help smokers avoid Post-Quit pounds
NCT ID NCT06173778
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a weekly injection of semaglutide (a drug used for weight loss and diabetes) can help adults with overweight or obesity avoid gaining weight after they stop smoking. About 197 participants will also use nicotine patches to help them quit. The goal is to see if semaglutide limits weight gain and changes appetite and body composition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- semaglutide (a once-weekly injection) and nicotine replacement therapy (nicotine patch)
- What this could lead to
- If it works, this could offer a way to prevent the weight gain that often happens when people quit smoking, making it easier to stay smoke-free.
- What could go wrong
- This is an early phase 2 trial with only 197 people, so results may not apply to everyone. Semaglutide can cause side effects like nausea and vomiting, and it's not yet proven to help with smoking cessation weight gain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 197 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: Medical Exclusions * 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. Psychiatric / Substance Use Exclusions * 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: 1. benzodiazepines 2. cocaine 3. opioids 4. amphetamines 5. methamphetamine 6. buprenorphine 7. barbiturates 8. 3,4-methylenedioxy-methamphetamine (MDMA) 9. Tetrahydrocannabinol (THC) * 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). Weight-Related Exclusions * 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) Smoking-Related Exclusions -Currently using other combustible (e.g., cigars), other (e.g., chewing tobacco, snuff, snus) or alternative (e.g., electronic cigarettes) tobacco products Medication-Related Exclusions * 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) General Exclusions * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77054, United States
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The University of Texas at Austin
RECRUITINGAustin, Texas, 78723, United States
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