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SKIP

CompletedPhase 2

Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues

Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues - a Randomized, Double-blind, Placebo-controlled Trial

Lead sponsor

University Hospital, Basel, Switzerland

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

256

actual

Study population

Alcohol / substance use

Key I/E criterion

•BMI 18-30

Primary endpoint

•Point prevalence abstinence rate

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 IDNCT03204396

Org study ID2017-00286

Timeline

Milestones

Study start2017-06-26actual

Study first posted2017-07-02actual

Primary completion2022-07-30actual

Study completion2022-08-30actual

Last update posted2022-09-13actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

for the main study:

•Age 18 to 75 years

•Daily smokers who are willing to quit and exhibit one of the following criteria: ≥10 cigarettes per day or

•At least moderate nicotine dependence defined by a Fagerstroem Score of ≥5 Points or

•Tobacco associated disease

•Treatment with varenicline (Champix®)

Additional Inclusion Criteria for the "substudy fMRI":

•Only patients aged 18-50 years are eligible

Additional Inclusion Criteria for the "substudy Energy":

•BMI of 18-30 kg/m2

Exclusion criteria

for the main study:

•Pregnancy (incl. wish to become pregnant within next 3 months) or breast feeding

•Pre-existing Treatment with GLP-1 agonists

•History of pancreatitis

•Severe renal insufficiency (estimated glomerular Filtration rate smaller than 30 ml/min/1.73 m2)

•Instable psychiatric conditions

•Anorexia nervosa

Additional Exclusion Criteria for the "substudy fMRI":

•Medical conditions that affect brain function (e.g. stroke, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, dementia, transient ischemic attack),

•Current use of medications that alter brain function

•Current illicit drug abuse including marijuana (alcohol ≤ 1 drink per day allowed)

•Claustrophobia, cardiac pacemaker, electronic device or ferromagnetic metal foreign bodies

Endpoints (16)

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

Weight & body composition

Other (unclassified)

Patient-reported / QoL

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in Body weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Change of body weight in kg (and BMI [kg/m²]) at week 4, 8, 24, and 52

Time frame:52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Change in body composition in the substudy "Energy"

Time frame:at week 0 and at week 12

Total fat mass

change from baseline, improvement

componentsTotal fat mass, Lean mass

Glycemic / diabetes

1 endpoint

Other/protocol endpoint

Change in haemoglobin A1c levels at week 12, 24, and 52

Time frame:52 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

1 endpoint

Other/protocol endpoint

Change in haemodynamic parameters in the substudy "Energy"

Time frame:at week 0, 12, 24, 52

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Other/protocol endpoint/low confidence

Change of craving at week 4 and 12 relative to baseline

Time frame:12 weeks

change from baseline, improvement

Other/protocol endpoint

Craving measured by a Visual Analogue Scale (VAS) in the substudy "fMRI"

Time frame:at week 12

descriptive

Other clinical outcomes

6 endpoints

Primary/protocol endpoint

Point prevalence abstinence rate at week 12

Time frame:12 weeks

threshold achievement, improvement

Other/protocol endpoint

Point prevalence abstinence rate at week 24 and 52

Time frame:52 weeks

threshold achievement, improvement

Other/protocol endpoint

Prolonged abstinence rate at week 24 and 52

Time frame:52 weeks

threshold achievement, improvement

Other/protocol endpoint/low confidence

Smoking reduction at week 12, 24, and 52

Time frame:52 weeks

change from baseline, improvement

Other/protocol endpoint

Working memory performance investigated by the N-back task score in the substudy "fMRI"

Time frame:at week 12

descriptive

Other/protocol endpoint

Change in structural plasticity of grey and white matter in fMRI in the substudy "fMRI"

Time frame:at week 0 and at week 12

change from baseline, descriptive

Other (unclassified)

3 endpoints

Other/protocol endpoint/low confidence

Blood oxygenated level dependent (BOLD) signal in fMRI in the substudy "fMRI"

Time frame:at week 12

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change of resting energy expenditure (REE) in the substudy "Energy"

Time frame:at week 0 and at week 12

change from baseline, descriptive

Other/protocol endpoint/low confidence

Change in sympathetic activity in the substudy "Energy"

Time frame:at week 0 and at week 12

change from baseline, descriptive

Publications (6)

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

Blood pressure changes during smoking cessation in a randomized, double-blind, placebo-controlled trial of dulaglutide treatment.
European journal of preventive cardiology2025 Oct 10PMID40037282doi:10.1093/eurjpc/zwaf055via clinicaltrials gov reference derived + pubmed nct search
Effect of dulaglutide in promoting abstinence during smoking cessation: 12-month follow-up of a single-centre, randomised, double-blind, placebo-controlled, parallel group trial.
EClinicalMedicine2024 Feb (month)PMID38371479doi:10.1016/j.eclinm.2024.102429via clinicaltrials gov reference derived + pubmed nct search
Gender differences in weight gain during attempted and successful smoking cessation on dulaglutide treatment: a predefined secondary analysis of a randomised trial.
BMJ nutrition, prevention & health2023 Dec (month)PMID38264360doi:10.1136/bmjnph-2023-000781via clinicaltrials gov reference derived + pubmed nct search
Effects of dulaglutide on alcohol consumption during smoking cessation.
JCI insight2023 Nov 22PMID37991022doi:10.1172/jci.insight.170419via clinicaltrials gov reference derived + pubmed nct search
Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)-a structured summary of a study protocol for a randomized controlled study.
Trials2023 Apr 20PMID37081574doi:10.1186/s13063-023-07164-9via clinicaltrials gov reference derived + pubmed nct search
Effect of dulaglutide in promoting abstinence during smoking cessation: a single-centre, randomized, double-blind, placebo-controlled, parallel group trial.
EClinicalMedicine2023 Mar (month)PMID36874396doi:10.1016/j.eclinm.2023.101865via clinicaltrials gov reference derived + pubmed nct search

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.