A study testing whether a new weekly shot from University of Southern California, tirzepatide, works for this condition.

Who can join
Adults 21 to 65, have smoking cessation, BMI 25+.
What you take
tirzepatide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
How long it lasts
The full study runs about 2.3 years; your own time in it is usually shorter.
What you get
The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
Phase Phase 2Sponsor University of Southern CaliforniaDrug tirzepatideClass GLP-1/GIPSites 4 USEnrollment target 300

What this study is for

Primary condition: Smoking Cessation. Also studied in: Smoking Behaviors.

Full scientific study title: Multi-Site Trial of Tirzepatide for Smoking Cessation.

Who can join

Age21 to 65SexAnyBMI25 or higher

Adults 21 to 65, have smoking cessation, BMI 25+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.

Full medical eligibility (for you and your doctor)verbatim from the registry

This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.

Key inclusion criteria

  • 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)

Key exclusion criteria

  • BMI < 25 kg/m2 at screening
  • History of diabetes, diabetes-attributable medical conditions, or HbA1c >=6.5% at baseline
  • Recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt
  • Current treatment for psychotic disorders or mood disorders with psychotic features (e.g., schizophrenia, schizoaffective disorder, depression with psychotic features), current treatment for bipolar disorder (with or without psychotic features), or current secondary psychosis due to substance use or another medical condition
  • Meeting DSM-5 criteria for a current (past 12 months) substance use disorder other than tobacco use disorder, mild or moderate cannabis use disorder, or mild or moderate alcohol use disorder.

Where this study is enrolling

This trial has 4 sites across 4 states. Contact a site coordinator directly to start screening.

California1 site
  • Keck School of Medicine, University of Southern California
    Los Angeles, California
    Tom Gilmore213-962-0698thomas.gilmore@usc.edu
Colorado1 site
Connecticut1 site
Illinois1 site

Timeline

Started enrolling: 2026-05-31. Expected completion: 2028-09. Last updated on ClinicalTrials.gov: 2026-05-22.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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