Smoking
Conditions
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 last approximately 34 weeks with up to 17 study visits, which includes a 2-week screening period, 24-week treatment period, 8-week safety follow-up period. .
Interventions
DRUGBrenipatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips | Week 1 to Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips | Week 1 to Week 24 |
| Mean Change from Baseline in Patient Reported Outcomes | Baseline, Week 24 |
| Mean Percentage Change in Body Weight | Baseline, Week 24 |
| Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide | Baseline up to Week 24 |
| Number of Treatment-emergent Anit-drug Antibodies | Baseline up to Week 24 |
Countries
China, Japan, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Outcome results
None listed