Multi-Site Trial of Tirzepatide for Smoking Cessation

What Was Tested

The trial (phase 2) is built around Tirzepatide.

Participants will attend weekly clinic visits to receive subcutaneous tirzepatide or placebo over 16 weeks (Visit Weeks 1-16), followed by follow-up visits at Week 17 and Week 27.

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

The registry classes the interventions as drug and other.

Who Took Part

300 planned participants were the target.

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: Age 21-65 years. Body mass index ≥ 25kg/m2 at the baseline screening. Reporting ≥10 cigarettes per day, on average, for the past 6 months and \> 2 year duration of smoking. Interest in making a long-term cessation attempt within the next 30-60 days. Willingness to receive study medication and standard-of-care smoking cessation supports (nicotine replacement therapy and a smoking cessation app).

The full record lists 9 inclusion and 25 exclusion criteria; among the exclusions: BMI \< 25 kg/m2 at screening; recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt; treatment with tirzepatide or another glp-1ra medication in the prior 6 months.

How the Study Was Run

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

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

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

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

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

It started in 2026-06-05 with completion listed for 2028-03.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 7-day point prevalence abstinence.

It also tracked 2 secondary outcomes, for example Cigarettes per day and Weekly cigarette craving.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 300 people.

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

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