CompletedPhase 1, PHASE2Results posted

Exenatide Once Weekly for Smoking Cessation

Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial

Lead sponsor

The University of Texas Health Science Center, Houston

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Alcohol / substance use, Obesity / overweight, Prediabetes / glucose intolerance

Eligibility highlights

•BMI ≥25•HbA1c 5.7-6.4%

Primary endpoints

•Number of Participants Who Self-Reported Abstinence•Post-quit Craving•Withdrawal Symptoms

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02975297

Org study IDHSC-MS-17-0802

Secondary IDCCTS Research Scholar AwardUTHealth

Timeline

Milestones

Study first posted2016-11-29estimated

Primary completion2020-01-03actual

Study completion2020-01-03actual

Last update posted2021-01-28actual

Results first posted2021-01-28actual

Study start2016-07actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Alcohol / substance useObesity / overweightPrediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Be English-speaking volunteers who desire to quit smoking and are willing to make a quit attempt during the course of the study;

•Have smoked ≥10 cigarettes a day for at least one year and provide a breath carbon monoxide (CO) ≥10 ppm;

•Have a negative pregnancy test, if female of childbearing potential;

•Have HbA1C levels between 5.7 and 6.4% or BMI of or greater than 25 kg/square meters

•Not currently using any therapy for glycemic control (either injectable [i.e. insulin] or oral agents);

•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 (within 10% above or below), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits;

•Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the principal investigator.

Exclusion criteria

•Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 3 months only; current alcohol dependence), J (substance abuse -Substance Abuse Addendum - past 3 months only; current substance dependence), K (current psychotic disorder or current mood disorder with psychotic features).

•Individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or Study Physician.

•Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI.

•Have personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;

•Have type 1 diabetes mellitus;

•Have severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris);

•Have active temporomandibular joint disease;

•Have severe gastrointestinal disease (i.e. severe gastroparesis);

•Have previous history of pancreatitis or are at risk for pancreatitis;

•Have creatinine clearance (CrCl) < 30;

•Have any previous medically adverse reaction to study medications, nicotine, or menthol;

•Be pregnant or lactating or unwilling to provide a negative pregnancy test before study entry;

•Not using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide);

•Have any illness which in the opinion of the primary investigator would preclude safe and/or successful completion of the study.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

4 endpoints

Primary/protocol endpoint

Post-quit Craving as Assessed by the Questionnaire of Smoking Urges

Time frame:6 weeks

change from baseline, improvement

Posted result

Group	Mean · score on a scale	95% CI
Exenatide Plus NRT Plus Counseling	17.2	-
Placebo Plus NRT Plus Counseling	16.9	-

Primary/protocol endpoint

Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale

Time frame:6 weeks

descriptive, improvement

Posted result

Group	Mean · score on a scale	95% CI
Exenatide Plus NRT Plus Counseling	40.5	-
Placebo Plus NRT Plus Counseling	44.5	-

Secondary/protocol endpoint

Post-quit Craving as Assessed by the Questionnaire of Smoking Urges

Time frame:7 weeks (1 week after end of treatment)

change from baseline, improvement

Posted result

Group	Mean · score on a scale	95% CI
Exenatide Plus NRT Plus Counseling	13.3	-
Placebo Plus NRT Plus Counseling	14.2	-

Secondary/protocol endpoint

Post-quit Craving as Assessed by the Questionnaire of Smoking Urges

Time frame:10 weeks (4 weeks after end of treatment)

change from baseline, improvement

Posted result

Group	Mean · score on a scale	95% CI
Exenatide Plus NRT Plus Counseling	11.5	-
Placebo Plus NRT Plus Counseling	11.2	-

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm

Time frame:6 weeks

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Exenatide Plus NRT Plus Counseling	19	-
Placebo Plus NRT Plus Counseling	11	-

Primary/protocol endpoint

Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges

Time frame:1 week

change from baseline, improvement

Primary/protocol endpoint

Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges

Time frame:3 weeks

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm

Time frame:7 weeks (1 week after end of treatment)

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Exenatide Plus NRT Plus Counseling	15	-
Placebo Plus NRT Plus Counseling	7	-

Secondary/protocol endpoint

Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm

Time frame:10 weeks (4 weeks after end of treatment)

threshold achievement, improvement

Posted result

Group	Participants	95% CI
Exenatide Plus NRT Plus Counseling	9	-
Placebo Plus NRT Plus Counseling	4	-

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Exenatide Adjunct to Nicotine Patch Facilitates Smoking Cessation and May Reduce Post-Cessation Weight Gain: A Pilot Randomized Controlled Trial.
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2021 Aug 29PMID33831213doi:10.1093/ntr/ntab066via clinicaltrials gov reference derived + pubmed nct search
Exenatide once weekly for smoking cessation: study protocol for a randomized clinical trial.
Medicine2018 Jan (month)PMID29480848doi:10.1097/MD.0000000000009567via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.