Exenatide for Smoking Cessation and Prevention of Weight Gain (NCT05610800) | Clinical Trial Compass
CompletedPhase 2
Exenatide for Smoking Cessation and Prevention of Weight Gain
United States140 participantsStarted 2022-12-07
Plain-language summary
The purpose of this study is to determine if exenatide improves end-of-treatment smoking abstinence rates and to determine if exenatide mitigates post-cessation weight gain.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Be willing and able to sign and date an informed consent form, willing to comply with all study procedures, and be available for the duration of the study
* Male or female, 18-75 years of age
* Have been smoking ≥5 cigarettes per day for at least 1 year and provide positive cotinine test
* Desire to quit smoking (defined as "intend to quit within one month")
* Have HbA1C levels between 5.7 and 6.4% and/or a body mass index of ≥25 kg/m2
* Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic
* Have hematology and chemistry laboratory tests that are within reference limits (±10%), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits
* Agree (if the subject is female and of child-bearing potential) to use at least one of the following methods of birth control from time of the first administration of the study medication to at least 7 days post the last dose of the study medication, unless the partner is surgically sterile (underwent vasectomy): oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm/spermicidal or condom/spermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, hormonal vaginal contraceptive ring, or complete abstinence from sexual intercourse.
* Women of child-bearing potential must provide negative urine pregnancy tests prior to randomization…
What they're measuring
1
Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level
Timeframe: Week 15
2
Weight change in kilograms at 12 weeks post-target quit day
Timeframe: Baseline, Week 15
Trial details
NCT IDNCT05610800
SponsorThe University of Texas Health Science Center, Houston