ObesityPhase 2NCT06173778
Semaglutide for Post-Smoking Cessation Weight Management
A Phase 2 study testing semaglutide 2.4mg, Nicotine Replacement Therapy (NRT, nicotine patch) and Brief Smoking Cessation Counseling in people with Obesity and Overweight, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Cigarette Smoking
- What is being tested?
- semaglutide 2.4mg, Nicotine Replacement Therapy (NRT, nicotine patch) and Brief Smoking Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Apr 2024to 25 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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:
- benzodiazepines
- cocaine
- opioids
- amphetamines
- methamphetamine
- buprenorphine
- barbiturates
- 3,4-methylenedioxy-methamphetamine (MDMA)
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Texas at Austin
Austin, Texas, 78723
Heather Leidy, PhD, 573-825-2620, Heather.Leidy@austin.utexas.edu
Connor Roenfeldt, 314-704-3842, Connor.Roenfeldt@austin.utexas.edu
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
Luba Yammine, PhD, 713-486-2737, Luba.Yammine@uth.tmc.edu
Jessica Vincent, 713-486-2803, Jessica.N.Vincent@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Obesity, Overweight, Cigarette Smoking
- Being tested
- semaglutide 2.4mg, Placebo, Nicotine Replacement Therapy (NRT, nicotine patch), Brief Smoking Cessation Counseling
- Keywords
- smoking, quit smoking, cigarettes, tobacco, overweight, obesity, obesity medications, semaglutide
- Medical subject headings
- Obesity, Overweight, Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutide 2.4mgDrug
Semaglutide 2.4mg will be self-administered once a week under the surface of the skin and will be started at 0.24mg or 0.25mg once a week for 4 weeks; in 4-week intervals, the dose will be increased until a dose of 2.4mg is reached
PlaceboDrug
Non-active medication, self-administered
Nicotine Replacement Therapy (NRT, nicotine patch)Drug
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 CounselingBehavioural
Participants will receive weekly, manual-based individual smoking cessation counseling. Counseling will be provided by master's level clinicians.
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | Experimental | Not described Receives: Drug: semaglutide 2.4mg; Drug: Nicotine Replacement Therapy (NRT, nicotine patch); Behavioral: Brief Smoking Cessation Counseling |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Nicotine Replacement Therapy (NRT, nicotine patch); Behavioral: Brief Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight Percent
Measured: Baseline to Week 28
Secondary outcomes (3)
Change in body weight as measured in kilograms (kg)
Measured: Baseline to Week 28
Change in body fat mass as measured in kilograms (kg)
Measured: Baseline to Week 28
Change in waist circumference as measured in centimeters(cm)
Measured: Baseline to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start23 Apr 2024
- Primary completion25 May 2028 (estimated)
- Study completion25 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luba Yammine, The University of Texas Health Science Center, Houston
- Investigators
- Luba Yammine, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173778
- Sponsor's protocol ID
- HSC-MS-23-0485
- Status last verified
- Sep 2026
- First submitted
- 7 Dec 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40554081