DelfaGLP-1 Atlas

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CompletedPhase 2

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

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

140

actual

Study population

Alcohol / substance use, Obesity / overweight

Key I/E criteria

•BMI ≥25•HbA1c 5.7-6.4%

Primary endpoints

•4-week continuous abstinence•Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05610800
Org study IDHSC-MS-21-0639

Timeline

Milestones

Study first posted2022-11-09actual
Study start2022-12-07actual
Primary completion2025-11-07actual
Study completion2026-03-10actual
Last update posted2026-03-23actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Alcohol / substance useObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

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%)
•Severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris)
•Severe gastrointestinal disease (i.e., severe gastroparesis)
•Previous history of pancreatitis or risk of pancreatitis
•Creatinine clearance <45 mL/min or end stage renal disease (ESRD)
•Previous medically adverse reaction to the study medications or nicotine
•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. Medically accepted forms of contraception are specified in the inclusion criterion 8.
•Current, anticipated, or pending enrollment in another research study over the next 6 months that could potentially affect subject safety and/or the study data/design as determined by the PI and/or Study Physician
•Unable to communicate (read, write, and speak) fluently in English
•Have any illness or condition which in the opinion of the PI and/or the Study Physician would preclude safe and/or successful completion of the study.

Endpoints (5)

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

Weight & body composition
2
Other clinical outcomes
2
Other (unclassified)
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Weight change in kilograms at 12 weeks post-target quit day

Time frame:Baseline, Week 15

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Weight change in kilograms at 24 weeks post-target quit day

Time frame:Baseline, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Other clinical outcomes

2 endpoints
Primary/protocol endpoint

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

Time frame:Week 15

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of participants with 4-week continuous abstinence at 24 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level

Time frame:Week 26

threshold achievement, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in amplitude of the late positive potential evoked by visual stimuli

Time frame:Week 1, Week 3

change from baseline, descriptive

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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 1, 2026 snapshot.