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Trial · Interventional

CompletedPhase 2Registry data

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

Short name SKIP

NCTNCT03204396 (opens ClinicalTrials.gov in a new tab)Other id2017-00286Other id2017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
256 participants (actual)
Sponsor
University Hospital, Basel, Switzerland · Other
Design
Randomized · Quadruple masking
Countries
1 country

Switzerland

Start
26 Jun 2017
Primary completion
30 Jul 2022
Completion
30 Aug 2022
First posted
2 Jul 2017
Last update posted
13 Sept 2022
Conditions
Glucagon-like Peptide-1 · Smoking Cessation · Weight Change, Body · Craving

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020202120222023
  1. Ph 2

    SKIP

    NCT03204396

    26 Jun 2017 to 30 Aug 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Cigarette smoking is the leading preventable cause of premature death worldwide. However smoking is a very difficult addiction to break whereby main reasons for not quitting or relapsing after cessation are the nicotine withdrawal syndrome and post-cessational weight gain. GLP-1 analogues are well known to stimulate insulin secretion and to reduce energy intake and therefore body weight. Recent findings from animal and human studies suggest a role of GLP-1 in the pathophysiology of addiction. The putative role of GLP-1 analogues in nicotine reward regulation combined with its weight reducing effects might be of major interest in view of novel pharmacotherapeutic options for smoking cessation. * Substudy "fMRI": This substudy is to evaluate effects of Dulaglutide treatment on functional neuronal changes in smokers who want to quit smoking. * Substudy "Energy": This substudy is to investigate the effect of Dulaglutide (Trulicity®) on REE and further parameters associated with energy metabolism (bodycomposition, haemodynamic parameters and catecholamine action) in a subset of patients recruited for the main trial.

Interventions

  • DulaglutideDrug
  • 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])Drug

Arms2

  • Active comparator

    Intervention group

    Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via pen s.c. once weekly for 12 weeks.

  • Placebo comparator

    Placebo group

    0.5 ml normal saline (0.9% sodium chloride (NaCl)), injection s.c. via syringe once weekly for 12 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Point prevalence abstinence rate at week 12

    Time frame · 12 weeks

    Registry description

    Point prevalence abstinence rate at week 12 of dulaglutide treatment and Standard of care (SOC) versus SOC alone, confirmed with end-expiratory exhaled carbon monoxide measurements of 10 ppm or less

Secondary outcomes(1)

  1. Change in Body weight

    Time frame · 12 weeks

    Registry description

    Change in body weight in kg (and BMI \[kg/m²\]) relative to baseline at week 12 of dulaglutide treatment versus placebo.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2025

7 results

Blood pressure changes during smoking cessation in a randomized, double-blind, placebo-controlled trial of dulaglutide treatment.

Beck et al. 2025European journal of preventive cardiologycited by 2

PMID 40037282DOI 10.1093/eurjpc/zwaf055PUB-40037282

Full text at the publisher7 results
Publisher pageSee results (7)

PubMed tag: none · 2024

9 results

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.

Lüthi et al. 2024EClinicalMedicinecited by 36

PMID 38371479PMC10873660DOI 10.1016/j.eclinm.2024.102429PUB-38371479

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

PubMed tag: none · 2023

5 results

Effect of dulaglutide in promoting abstinence during smoking cessation: a single-centre, randomized, double-blind, placebo-controlled, parallel group trial.

Lengsfeld et al. 2023EClinicalMedicinecited by 69

PMID 36874396PMC9981899DOI 10.1016/j.eclinm.2023.101865PUB-36874396

Free to read · publisher termsCC BY-NC-ND5 results
Read at sourceSee results (5)

Indexing hint: Randomized controlled trial · 2023

2 results

Effects of dulaglutide on alcohol consumption during smoking cessation.

Probst et al. 2023JCI insightcited by 73

PMID 37991022PMC10721313DOI 10.1172/jci.insight.170419PUB-37991022

CC BY2 results
Download PDFSee results (2)

PubMed tag: none · 2023

4 results

Gender differences in weight gain during attempted and successful smoking cessation on dulaglutide treatment: a predefined secondary analysis of a randomised trial.

Baur et al. 2023BMJ nutrition, prevention & healthcited by 3

PMID 38264360PMC10800263DOI 10.1136/bmjnph-2023-000781PUB-38264360

Free to read · publisher termsCC BY-NC4 results
Read at sourceSee results (4)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLengsfeld S, Burkard T, Meienberg A, Jeanloz N, Coynel D, Vogt DR, Hemkens LG, Speich B, Zanchi D, Erlanger TE, Christ-Crain M, Winzeler B. Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)-a structured summary of a study protocol for a randomized controlled study. Trials. 2023 Apr 20;24(1):284. doi: 10.1186/s13063-023-07164-9. PMID 37081574

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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