Trials / Recruiting
RecruitingNCT07223840
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 222 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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. .
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brenipatide | Administered SC |
| DRUG | Placebo | Administered SC |
Timeline
- Start date
- 2025-11-03
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2025-11-03
- Last updated
- 2026-04-17
Locations
27 sites across 3 countries: United States, China, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07223840. Inclusion in this directory is not an endorsement.