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Could a diabetes drug help smokers kick the habit and avoid weight gain?

NCT ID NCT07602699

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests whether tirzepatide, a drug used for diabetes and weight loss, can help people with overweight or obesity quit smoking. 300 smokers will receive either the drug or a placebo, plus nicotine patches, for 16 weeks. The goal is to see if the drug improves quit rates and reduces weight gain often seen after quitting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 21-65 years 2. Body mass index ≥ 25kg/m2 at the baseline screening 3. Reporting ≥10 cigarettes per day, on average, for the past 6 months and \> 2 year duration of smoking 4. Interest in making a long-term cessation attempt within the next 30-60 days 5. Willingness to receive study medication and standard-of-care smoking cessation supports (nicotine replacement therapy and a smoking cessation app) 6. Ability to adhere to weekly visits and study procedures over the study period (i.e., no plans to move or travel for extended periods) 7. Exhaled CO of \>5ppm at baseline 8. Use of an acceptable birth control method for female participants\* 9. Ability to read and communicate in English Exclusion Criteria: 1. BMI \< 25 kg/m2 at screening 2. History of diabetes, diabetes-attributable medical conditions, or HbA1c ≥6.5% at baseline 3. Recent (past 90 days) active suicidal ideation or lifetime history of suicide attempt 4. 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 5. 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. 6. Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is prescribed an opioid replacement therapy medication and can provide documentation. 7. Past 30-day initiation of psychiatric medications (e.g., SSRIs) or changes to medication dose 8. Treatment with tirzepatide or another GLP-1RA medication in the prior 6 months 9. Current (past month) treatment with other weight loss, diabetes, or smoking cessation medications (varenicline or bupropion; excluding nicotine replacement products) 10. Severe GI disease (e.g., gastroparesis, ulcerative colitis). 11. History of gastric bypass surgery or other surgeries of the stomach 12. Any health condition or treatment/medication that would preclude the use of tirzepatide or NRT, in the opinion of the study physician, including severe cardiovascular disease 13. History of chronic pancreatitis or acute pancreatitis in the last 6 months 14. Currently nursing, pregnant, or anticipating pregnancy 15. History of diabetic retinopathy, proliferative retinopathy, or maculopathy 16. Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (\>5x upper limit of normal range) 17. History of malignant neoplasms in the last 5 years, except non-melanoma skin cancer 18. Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule) 19. Currently enrolled in another clinical study involving an investigational product 20. Currently living in the same household as someone taking a GLP-1 medication, or living with a current or former participant in the present trial 21. Planned surgical procedures requiring anesthesia during the planned study medication period 22. Personal or family history of medullary thyroid cancer 23. Personal or family history of multiple endocrine neoplasia syndrome type 2 (MEN 2) 24. Treatment with other weight loss (e.g., phentermine), or FDA-approved, non-NRT smoking cessation therapies (varenicline, bupropion) or FDA-approved AUD medications (naltrexone, acamprosate, disulfiram) or off-label AUD medications (e.g., topiramate) in the past 90 days 25. Any health condition or treatment/medication that would preclude use of tirzepatide or NRT, in the opinion of the site physicians including thyroid enlargement.

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Conditions

The condition(s) this trial relates to.

Behavior, Addictive nicotine dependence Smoking Smoking Cessation substance-related disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Keck School of Medicine, University of Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Chicago Pritzker School of Medicine

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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