RECRUITING

Semaglutide for Post-Smoking Cessation Weight Management

Conditions

Obesity Overweight Cigarette Smoking smoking quit smoking cigarettes tobacco obesity medications semaglutide

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-23

Study Completion:2026-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06173778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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: 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). * 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 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.

Inclusion Criteria

Exclusion 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

* 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:
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).
* 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 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.

Contacts and Locations

Study Contact

Luba Yammine, PhD

CONTACT

713-486-2737

Luba.Yammine@uth.tmc.edu

Jessica Vincent

CONTACT

713-486-2803

Jessica.N.Vincent@uth.tmc.edu

Principal Investigator

Luba Yammine, PhD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77054

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Luba Yammine, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-23

Study Completion Date2026-08-01

Study Record Updates

Study Start Date2024-04-23

Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

smoking
quit smoking
cigarettes
tobacco
overweight
obesity
obesity medications
semaglutide

Additional Relevant MeSH Terms

Obesity
Overweight
Cigarette Smoking