deltatrials
Recruiting INTERVENTIONAL NCT07223840

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (RENEW-Smk-1)

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)

Sponsor: Eli Lilly and Company

Conditions Smoking
Updated 5 times since 2025 Last updated: Apr 16, 2026 Started: Nov 3, 2025 Primary completion: Feb 1, 2027 Completion: Feb 1, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT07223840, this observational or N/A phase trial focuses on Smoking and remains actively recruiting participants. Sponsored by Eli Lilly and Company, it has been updated 5 times since 2025, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshotRecruiting~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshotRecruiting~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshotRecruiting~Mar 2026 – ~Apr 2026 · 48 days · monthly snapshotRecruitingApr 18, 2026 – present · 4 months · daily APIRecruiting

Change History

5 versions recorded
  1. Apr 18, 2026 — Present [daily]

    Recruiting

    Phase: PHASE2None

  2. Mar 2026 — Apr 2026 [monthly]

    Recruiting PHASE2

  3. Feb 2026 — Mar 2026 [monthly]

    Recruiting PHASE2

  4. Jan 2026 — Feb 2026 [monthly]

    Recruiting PHASE2

  5. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE2

    First recorded

Nov 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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. .

Contact Information

Sponsor contact:
  • Eli Lilly and Company
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .