Semaglutide for Post-Smoking Cessation Weight Management

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide) and Semaglutide.

It had two arms (groups): semaglutide (experimental) and placebo (placebo comparator).

The registry classes the interventions as behavioral and drug.

Who Took Part

197 planned participants were the target.

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: Ability to provide informed consent before any study-related activity, willing to comply with al study procedures, and be available for the duration of the study. Have been smoking ≥5 cigarettes per day for at least 1 year (prior to screening) and provide positive cotinine test. Desire to quit smoking (defined as "intend to quit within one month"). Women of child-bearing potential must provide negative urine pregnancy tests prior to randomization. Normal cognitive restraint (assessed as cognitive restraint score of \<4 from the Three Factor Eating Habits Questionnaire).

The full record lists 8 inclusion and 38 exclusion criteria; among the exclusions: personal or first-degree relative(s) history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2); acute pancreatitis within the past 6 months prior to screening; history or presence of chronic pancreatitis.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

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

It started in 2024-04-23 with completion listed for 2028-05-25.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Body Weight Percent (time frame: Baseline to Week 28).

It also tracked 3 secondary outcomes, for example Change in body weight as measured in kilograms (kg), Change in body fat mass as measured in kilograms (kg) and Change in waist circumference as measured in centimeters(cm).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) and Semaglutide in 197 people.

It is still recruiting; 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 Semaglutide compound page, all human trials.