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RECRUITING
NCT07602699
PHASE2

Multi-Site Trial of Tirzepatide for Smoking Cessation

Sponsor: University of Southern California

View on ClinicalTrials.gov

Summary

This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., post-cessation weight gain) in treatment-seeking people who smoke (PWS) with overweight or obesity. A sample of 300 treatment-seeking people who smoke with body mass index of 25 kg/m2 or greater will be recruited from four geographic sites (University of Southern California, Yale University, University of Chicago, and University of Colorado Anschutz Medical Campus) to participate in a parallel-arm, dose-escalating, placebo-controlled trial. 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. Medication will be prescribed according to the standard dose titration schedule for the first 16 weeks of treatment (initial dose: 2.5mg/week; final dose: 10mg/week). All participants will also receive nicotine patches.

Official title: A Multi-Site Trial of Tirzepatide for Smoking Cessation

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-06-05

Completion Date

2028-09

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DRUG

Tirzepatide

Participants will receive tirzepatide (subcutaneous injection) at doses of 2.5mg for Weeks 1-4, 5mg for Weeks 5-8, 7.5mg for Weeks 9-12, and 10mg for Weeks 13-16

OTHER

Placebo

Participants will receive placebo (saline) injections for Weeks 1-16

Locations (4)

Keck School of Medicine, University of Southern California

Los Angeles, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

University of Chicago Pritzker School of Medicine

Chicago, Illinois, United States