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

NCT03204396 | Completed Phase 2 DMC

• 1 other identifier: 2017-00286
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Glucagon-like Peptide-1; Smoking Cessation; Weight Change, Body; Craving

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (1)

• Change in Body weight

  12 weeks

Other Outcomes (14)

• Point prevalence abstinence rate at week 24 and 52

  52 weeks

• Prolonged abstinence rate at week 24 and 52

  52 weeks

• Smoking reduction at week 12, 24, and 52

  52 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

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.

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

Interventions

Dulaglutide DRUG

Application of Dulaglutide (Trulicity®) 1.5 mg s.c. once weekly for 12 weeks.

Also known as: Trulicity

Intervention group

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®)
• Only patients aged 18-50 years are eligible
• BMI of 18-30 kg/m2

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 40037282 DERIVED

• Luthi 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.

  PMID: 38371479 DERIVED

• Baur 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.

  PMID: 38264360 DERIVED

• Probst 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.

  PMID: 37991022 DERIVED

• Lengsfeld 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 DERIVED

• Lengsfeld 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.

  PMID: 36874396 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Body Weight Changes

Interventions

dulaglutide; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bettina Winzeler, Dr.

  University Hospital Basel, Endokrinology, diabetology, metabolism

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: June 26, 2017
• Primary Completion: July 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)