Brenipatide to help adults who recently quit smoking avoid relapse

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 trial tests brenipatide in adults who have recently quit smoking to reduce the risk of relapse. Participants receive brenipatide or matching placebo during a 24-week treatment period, with a total participation time of about 34 weeks including screening and an 8-week safety follow-up. The protocol involves up to 17 clinic visits and requires participants to be willing to self-inject the study medication and follow study procedures. The study excludes people with recent substance use disorders (except some mild cases), recent suicidal ideation/behavior, or severe respiratory disease and is sponsored by Eli Lilly at three U.S. research sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Woodland Research Northwest
  Rogers, Arkansas, United States Recruiting
• TecTum Research
  Hollywood, Florida, United States Recruiting
• K2 Medical Research ORLANDO
  Maitland, Florida, United States Recruiting
• GTL Medical & Research Group
  Miami, Florida, United States Recruiting
• Conquest Research - Orlando
  Orlando, Florida, United States Recruiting
• North Georgia Clinical Research
  Woodstock, Georgia, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.