Semaglutide for Post-Smoking Cessation Weight Management

February 6, 2026 updated by: Luba Yammine, The University of Texas Health Science Center, Houston

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

197

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78723
      • Houston, Texas, United States, 77054
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luba Yammine, PhD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: 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.
Behavioral: Brief Smoking Cessation Counseling
Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.
Drug: Placebo
Non-active medication, self-administered
Experimental: semaglutide
Drug: 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
Drug: 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.
Behavioral: Brief Smoking Cessation Counseling
Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Body Weight Percent
Time Frame: Baseline to Week 28
Baseline to Week 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in body weight as measured in kilograms (kg)
Time Frame: Baseline to Week 28
Baseline to Week 28
Change in body fat mass as measured in kilograms (kg)
Time Frame: Baseline to Week 28
Baseline to Week 28
Change in waist circumference as measured in centimeters(cm)
Time Frame: Baseline to Week 28
Baseline to Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Luba Yammine, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

April 23, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-23-0485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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