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Brenipatide for Preventing Smoking Relapse

This study is testing a drug called brenipatide to see if it can help adults who recently quit smoking stay smoke-free. Researchers want to compare brenipatide to a placebo (an inactive substance) to see if it's effective and safe in preventing people from starting to smoke cigarettes again. You might be able to join if you are between 18 and 75 years old, have recently quit smoking, and are motivated to stay quit. The main goal is to see what percentage of participants can continuously stay away from cigarettes, confirmed by carbon monoxide (CO) tests, for 24 weeks. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 222 participants. Participants will receive either brenipatide or a placebo, both administered as a subcutaneous (under the skin) injection.
What's involved
Your participation will last about 34 weeks, including a 2-week screening, 24 weeks of treatment, and an 8-week safety follow-up. You will have up to 17 study visits and will need to self-inject the study intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 8 weeks after the 24-week treatment period for safety.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07223840

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Eli Lilly and Company
~222 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BrenipatidePlacebo

At a glance

Recruiting sites
26 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips
Measured over Week 1 to Week 24

Conditions

Smoking

Explore related trials

Smoking

Where it's being run

29 sites across 14 states
China8
Florida5
Texas3
Japan3
Arkansas1
Georgia1
Michigan1
Missouri1

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have recently quit smoking and are motivated to stay quit from smoking
Are reliable and willing to make themselves available for the duration of the study and attend required study visits and are willing and able to follow study procedures as required, such as self-inject study intervention

Exclusion

Have evidence of any substance use disorder within the past 180 days prior to screening, except mild alcohol use disorder, mild cannabis use disorder, or tobacco use disorder
Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the C-SSRS and the ideation occurred within the past 6 months, or have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months
Have severe chronic obstructive pulmonary disease, or any other clinically severe respiratory condition that in the investigator's opinion may pose a risk.
Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

What this trial measures

  • Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed SlipsWeek 1 to Week 24