Glucagon-like Peptide-1Phase 2SKIPNCT03204396
Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues
A Phase 2 study testing Dulaglutide and 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) in people with Glucagon-like Peptide-1 and Smoking Cessation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucagon-like Peptide-1, Smoking Cessation, Weight Change, Body
- What is being tested?
- Dulaglutide and 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Jun 2017to 30 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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":
Show all 9Show fewer
- Only patients aged 18-50 years are eligible
- Additional Inclusion Criteria for the "substudy Energy":
- BMI of 18-30 kg/m2
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues - a Randomized, Double-blind, Placebo-controlled Trial
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.
Read the detailed description
Cigarette smoking is the leading preventable cause of premature death worldwide. However smoking is a very difficult addiction to break and despite established smoking cessation programs quit rates are low, especially in the real-life setting. The 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" (60 patients): Supposing that GLP-1 and analogues modulates nicotine induces reward system this substudy is to analyze if treatment with Dulaglutide (Trulicity®) attenuates craving and therefore functional brain activation. It is to evaluate effects of Dulaglutide treatment on functional neuronal changes in smokers who want to quit smoking.
- Substudy "Energy" (60 patients): The aim of the substudy "Energy" 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.
- Being tested
- Dulaglutide, 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])
- Medical subject headings
- Smoking Cessation, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Also called Trulicity
Application of Dulaglutide (Trulicity®) 1.5 mg s.c. once weekly for 12 weeks.
0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])Drug
Application of 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) once weekly for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Dulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via pen s.c. once weekly for 12 weeks. Receives: Drug: Dulaglutide |
| Placebo group | Placebo comparator | 0.5 ml normal saline (0.9% sodium chloride (NaCl)), injection s.c. via syringe once weekly for 12 weeks. Receives: Drug: 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence rate at week 12
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
Measured: 12 weeks
Secondary outcomes (1)
Change in Body weight
Change in body weight in kg (and BMI [kg/m²]) relative to baseline at week 12 of dulaglutide treatment versus placebo.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start26 Jun 2017
- Primary completion30 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glucagon-like Peptide-1Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Winzeler, Dr., Principal investigator, University Hospital Basel, Endokrinology, diabetology, metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204396
- Sponsor's protocol ID
- 2017-00286
- Other IDs
- 2017
- Acronym
- SKIP
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2017
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beck J, Hasenbohler F, Werlen L, Lengsfeld S, Meienberg A, Bathelt C, Vogt D, Christ-Crain M, Burkard T, Winzeler B. Blood pressure changes during smoking cessation in a randomized, double-blind, placebo-controlled trial of dulaglutide treatment. Eur J Prev Cardiol. 2025 Oct 10;32(14):1394-1402. doi: 10.1093/eurjpc/zwaf055.
PubMed 40037282Luthi H, Lengsfeld S, Burkard T, Meienberg A, Jeanloz N, Vukajlovic T, Bologna K, Steinmetz M, Bathelt C, Sailer CO, Laager M, Vogt DR, Hemkens LG, Speich B, Urwyler SA, Kuhne J, Baur F, Lutz LN, Erlanger TE, Christ-Crain M, Winzeler B. 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. EClinicalMedicine. 2024 Feb 9;68:102429. doi: 10.1016/j.eclinm.2024.102429. eCollection 2024 Feb.
PubMed 38371479Baur F, Atila C, Lengsfeld S, Burkard T, Meienberg A, Bathelt C, Christ-Crain M, Winzeler B. Gender differences in weight gain during attempted and successful smoking cessation on dulaglutide treatment: a predefined secondary analysis of a randomised trial. BMJ Nutr Prev Health. 2023 Dec;6(2):301-309. doi: 10.1136/bmjnph-2023-000781. Epub 2023 Dec 19.
PubMed 38264360Probst L, Monnerat S, Vogt DR, Lengsfeld S, Burkard T, Meienberg A, Bathelt C, Christ-Crain M, Winzeler B. Effects of dulaglutide on alcohol consumption during smoking cessation. JCI Insight. 2023 Nov 22;8(22):e170419. doi: 10.1172/jci.insight.170419.
PubMed 37991022Lengsfeld 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.
PubMed 37081574Lengsfeld S, Burkard T, Meienberg A, Jeanloz N, Vukajlovic T, Bologna K, Steinmetz M, Bathelt C, Sailer CO, Vogt DR, Hemkens LG, Speich B, Urwyler SA, Kuhne J, Baur F, Lutz LN, Erlanger TE, Christ-Crain M, Winzeler B. Effect of dulaglutide in promoting abstinence during smoking cessation: a single-centre, randomized, double-blind, placebo-controlled, parallel group trial. EClinicalMedicine. 2023 Feb 21;57:101865. doi: 10.1016/j.eclinm.2023.101865. eCollection 2023 Mar.
PubMed 36874396
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues - a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03204396
- Acronym / sponsor ID
- SKIP / 2017-00286
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cigarette smoking is the leading preventable cause of premature death worldwide. However smoking is a very difficult addiction to break and despite established smoking cessation programs quit rates are low, especially in the real-life setting. The 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" (60 patients): Supposing that GLP-1 and analogues modulates nicotine induces reward system this substudy is to analyze if treatment with Dulaglutide (Trulicity®) attenuates craving and therefore functional brain activation. It is to evaluate effects of Dulaglutide treatment on functional neuronal changes in smokers who want to quit smoking.
- Substudy "Energy" (60 patients): The aim of the substudy "Energy" 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: DulaglutideDulaglutide (Trulicity®) 1.5 mg in 0.5 ml, via pen s.c. once weekly for 12 weeks. |
| Placebo group | Placebo comparator | Drug: 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])0.5 ml normal saline (0.9% sodium chloride (NaCl)), injection s.c. via syringe once weekly for 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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®)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DulaglutideAlso: TrulicityApplication of Dulaglutide (Trulicity®) 1.5 mg s.c. once weekly for 12 weeks. | Drug | Intervention group |
| 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])Application of 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) once weekly for 12 weeks | Drug | Placebo group |
Primary outcome
Point prevalence abstinence rate at week 12
Time frame: 12 weeks
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
1 secondary outcome
Change in Body weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Derived from this study: PubMed 40037282Beck J, Hasenbohler F, Werlen L, Lengsfeld S, Meienberg A, Bathelt C, Vogt D, Christ-Crain M, Burkard T, Winzeler B. Blood pressure changes during smoking cessation in a randomized, double-blind, placebo-controlled trial of dulaglutide treatment. Eur J Prev Cardiol. 2025 Oct 10;32(14):1394-1402. doi: 10.1093/eurjpc/zwaf055.
- Derived from this study: PubMed 38371479Luthi H, Lengsfeld S, Burkard T, Meienberg A, Jeanloz N, Vukajlovic T, Bologna K, Steinmetz M, Bathelt C, Sailer CO, Laager M, Vogt DR, Hemkens LG, Speich B, Urwyler SA, Kuhne J, Baur F, Lutz LN, Erlanger TE, Christ-Crain M, Winzeler B. 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. EClinicalMedicine. 2024 Feb 9;68:102429. doi: 10.1016/j.eclinm.2024.102429. eCollection 2024 Feb.
- Derived from this study: PubMed 38264360Baur F, Atila C, Lengsfeld S, Burkard T, Meienberg A, Bathelt C, Christ-Crain M, Winzeler B. Gender differences in weight gain during attempted and successful smoking cessation on dulaglutide treatment: a predefined secondary analysis of a randomised trial. BMJ Nutr Prev Health. 2023 Dec;6(2):301-309. doi: 10.1136/bmjnph-2023-000781. Epub 2023 Dec 19.
- Derived from this study: PubMed 37991022Probst L, Monnerat S, Vogt DR, Lengsfeld S, Burkard T, Meienberg A, Bathelt C, Christ-Crain M, Winzeler B. Effects of dulaglutide on alcohol consumption during smoking cessation. JCI Insight. 2023 Nov 22;8(22):e170419. doi: 10.1172/jci.insight.170419.
- Derived from this study: PubMed 37081574Lengsfeld 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.
- Derived from this study: PubMed 36874396Lengsfeld S, Burkard T, Meienberg A, Jeanloz N, Vukajlovic T, Bologna K, Steinmetz M, Bathelt C, Sailer CO, Vogt DR, Hemkens LG, Speich B, Urwyler SA, Kuhne J, Baur F, Lutz LN, Erlanger TE, Christ-Crain M, Winzeler B. Effect of dulaglutide in promoting abstinence during smoking cessation: a single-centre, randomized, double-blind, placebo-controlled, parallel group trial. EClinicalMedicine. 2023 Feb 21;57:101865. doi: 10.1016/j.eclinm.2023.101865. eCollection 2023 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina Winzeler, Dr. principal investigator
University Hospital Basel, Endokrinology, diabetology, metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dulaglutide and 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) in people with Glucagon-like Peptide-1 and Smoking Cessation, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence abstinence rate at week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03204396, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.