Semaglutide for Post-Smoking Cessation Weight Management
NCT ID: NCT06173778
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
197 participants
INTERVENTIONAL
2024-04-23
2026-08-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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semaglutide
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
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.
Brief Smoking Cessation Counseling
Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.
placebo
Placebo
Non-active medication, self-administered
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.
Brief Smoking Cessation Counseling
Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.
Interventions
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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
Placebo
Non-active medication, self-administered
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.
Brief Smoking Cessation Counseling
Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Luba Yammine
Associate Professor
Principal Investigators
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Luba Yammine, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas at Austin
Austin, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Heather Leidy, PhD
Role: primary
Connor Roenfeldt
Role: backup
Luba Yammine, PhD
Role: primary
Jessica Vincent
Role: backup
References
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Yammine L, Leidy H, Maki KC, Weaver MF, Bodalski EA, Schmitz JM. A randomized controlled trial of once-weekly semaglutide for limiting post-smoking cessation weight gain in smokers with overweight/obesity: Study protocol. Contemp Clin Trials. 2025 Aug;155:107989. doi: 10.1016/j.cct.2025.107989. Epub 2025 Jun 18.
Other Identifiers
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HSC-MS-23-0485
Identifier Type: -
Identifier Source: org_study_id