Exenatide for Smoking Cessation and Prevention of Weight Gain

What Was Tested

This registered phase 2 trial tested Therapeutic nicotine (patch, non-peptide) and Exenatide.

It had two arms (groups): Exenatide, NRT, and Smoking Cessation Counseling (active comparator) and Placebo, NRT, and Smoking Cessation Counseling (placebo comparator).

Participants will receive once weekly exenatide injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions.

Participants will receive once weekly saline injections, daily nicotine patches (NRT), and once weekly individual smoking cessation counseling sessions.

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 140 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: Be willing and able to sign and date an informed consent form, willing to comply with all study procedures, and be available for the duration of the study. Male or female, 18-75 years of age. Have been smoking ≥5 cigarettes per day for at least 1 year and provide positive cotinine test. Desire to quit smoking (defined as "intend to quit within one month"). Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic.

The full record lists 10 inclusion and 19 exclusion criteria; among the exclusions: psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 3 months (existing diagnosis or as determined by the structured interview); currently using chewing tobacco, snuff, snus or electronic cigarettes; currently using oral or injectable glucose lowering medications.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2022-12-07 with completion listed for 2025-11-07.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level (time frame: Week 15). Weight change in kilograms at 12 weeks post-target quit day (time frame: Baseline, Week 15).

It also tracked 3 secondary outcomes, for example Weight change in kilograms at 24 weeks post-target quit day and Change in amplitude of the late positive potential evoked by visual stimuli.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) and Exenatide in 140 people.

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

More context: the Therapeutic nicotine (patch, non-peptide) compound page and the Exenatide compound page, all human trials.