Semaglutide for Post-Smoking Cessation Weight Management
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center, Houston
About this trial
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.
Eligibility criteria
Qualifiers
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")
Disqualifiers
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).
Trial design
Treatments tested in this trial
- semaglutide 2.4mg
- Placebo
- Nicotine Replacement Therapy (NRT, nicotine patch)
- Brief Smoking Cessation Counseling
Treatment groups
197 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov