A Phase 2, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for Reduction in Risk of Relapse to Cigarette Smoking in Adults (RENEW-Smk-1)
Eli Lilly and Company
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. .
Eligibility
- Age range
- 18–75 years
- Sex
- All
- 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"…
Interventions
- DrugBrenipatide
Administered SC
- DrugPlacebo
Administered SC
Locations (27)
- Woodland Research NorthwestRogers, Arkansas
- Hillcrest Medical ResearchDeLand, Florida
- TecTum ResearchHollywood, Florida
- K2 Medical Research ORLANDOMaitland, Florida
- GTL Medical & Research GroupMiami, Florida
- North Georgia Clinical ResearchWoodstock, Georgia