Impact of Semaglutide on Tobacco Use and Related Health Behaviors

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

This pilot randomized trial will assess the impact of 12 weeks of semaglutide administration (vs placebo) on changes in: (i) tobacco use and related factors (nicotine craving, withdrawal, motivation to quit, etc.) and (ii) biological biomarkers of health (e.g., epigenetics, glucose variability via continuous glucose monitoring \[CGM\], etc.) in adult smokers with obesity (n = 40).

The researchers will integrate molecular biology procedures (e.g., epigenetics) to maximize internal validity with real-world smartphone-based ecological momentary assessment (EMA) surveys to maximize external validity.

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

Participants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks.

Participants will be randomized to receive active semaglutide or placebo (saline) injection once a week for 12weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Report daily use of \>2 cigarettes per day (CPD), as this is a sufficient threshold for detecting tobacco use disorder, per MPI Oliver's published work57;. Meet criteria for obesity (BMI ≥30 kg/m2); and. No immediate desire to quit tobacco use (using criteria form the clinical practice guidelines for treating tobacco dependence).

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: severe psychiatric disturbance precluding successful completion of the study, defined as; current use of nicotine replacement therapy or other quit smoking medication;; history of bariatric surgery;.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

The Semaglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2024-07-01 with completion listed for 2028-05-30.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Cigarette smoking (time frame: 12 weeks).

It also tracked 1 secondary outcome, for example Weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 40 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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