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Exenatide for Smoking Cessation and Prevention of Weight Gain | Clinical Trials | Clareo Health

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Exenatide for Smoking Cessation and Prevention of Weight Gain

A Randomized Controlled Trial of Exenatide as an Adjunct to Nicotine Patch for Smoking Cessation and Prevention of Post-Cessation Weight Gain

NCT05610800•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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
•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 PI.

Exclusion Criteria

•Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 3 months (existing diagnosis or as determined by the structured interview)
•Currently using chewing tobacco, snuff, snus or electronic cigarettes
•Currently enrolled in a smoking cessation program/research study or using pharmacotherapy for smoking cessation (NRT, varenicline, or bupropion)
•Currently enrolled in a behavioral weight management plan/research study, or taking medication used for weight management (i.e., orlistat, lorcaserin,\*naltrexone-bupropion, liraglutide, phentermine, benzhetamine, diethylpropion, phendimetrazine), or medication known to impact weight (i.e., corticosteroids) \*Note: Withdrawn from the market in Feb 2020, but some patients may still be taking it
•Currently using oral or injectable glucose lowering medications
•Urine drug test positive, before randomization, for any of the following substances: benzodiazepines, cocaine, opioids,\*amphetamines, methamphetamine, buprenorphine, barbiturates, 3,4-methylenedioxy-methamphetamine (MDMA), and/or THC. \*Note: If positive for opioids or oxycodone but recent opioid use for acute pain is reported by the study candidate, then the candidate can be included at the discretion of the Primary Investigator and/or Study Physician
•Psychotic or bipolar disorder, or mood disorder with psychotic features, or eating disorder (existing diagnosis or as determined by the structured interview)
•Moderate to high risk for suicidality (as determined by the structured interview)
•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
•Type 1 or type 2 diabetes mellitus (previously diagnosed or indicated by HbA1C level of ≥6.5%)
+9 more criteria

Locations (2)

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

December 7, 2022

Primary Completion Date

November 7, 2025

Completion Date

January 30, 2026

Last Updated

January 22, 2026

Enrollment

140

ACTUAL participants

Conditions

Smoking CessationWeight Gain

Interventions

Exenatide 2 milligram (mg) Injection

DRUG

Placebo

DRUG

Nicotine patch

DRUG

Smoking Cessation Counseling

BEHAVIORAL

Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients

NCT07441928

Smoking CessationSchizophenia Disorder

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RECRUITINGNA

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

NCT05780814

Breast CancerInsomnia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exenatide for Smoking Cessation and Prevention of Weight Gain

Inclusion Criteria

Exclusion Criteria

Effects of Smoking on Network Connectivity in Patients With Schizophrenia Symptoms in Scz Patients

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

Smoking Cessation Pharmacotherapy-Nurse Practitioner Led Tobacco Treatment Team Study

Cessation of Dual Use of Cigarettes and E-cigarettes During Pregnancy

Effects of Smoking Addiction on Lower Limb Speed and Coordination

tDCS Plus Varenicline for Smoking Cessation