Status:
RECRUITING
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
Lead Sponsor:
Eli Lilly and Company
Conditions:
Smoking
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. Study participation will l...
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
Key Trial Info
Start Date :
November 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT07223840
Start Date
November 3 2025
End Date
February 1 2027
Last Update
December 18 2025
Active Locations (28)
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1
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
2
Hillcrest Medical Research
DeLand, Florida, United States, 32720
3
TecTum Research
Hollywood, Florida, United States, 33024
4
K2 Medical Research ORLANDO
Maitland, Florida, United States, 32751