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

What Was Tested

In this phase 2 trial, researchers set out to test Dulaglutide.

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.

It had two arms (groups): Intervention group (active comparator) and Placebo group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 256 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could 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®).

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: pregnancy (incl. wish to become pregnant within next 3 months) or breast feeding; pre-existing treatment with glp-1 agonists; history of pancreatitis.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Dulaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-06-26 with completion listed for 2022-07-30.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Point prevalence abstinence rate at week 12 (time frame: 12 weeks).

It also tracked 1 secondary outcome, for example Change in Body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Dulaglutide in 256 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Dulaglutide compound page, all human trials.