NCT07223840: 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)

Recruiting now Phase 2 Last updated 20 May 2026

What this trial tests

Phase 2 trial testing Brenipatide in Smoking in 222 participants. Currently enrolling.

Timeline

3 November 2025

Primary endpoint
1 February 2027

1 February 2027

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	222
Start date	3 November 2025
Primary completion	1 February 2027
Estimated completion	1 February 2027
Sites	27 locations across United States, China, Japan

Drugs / interventions tested

• Brenipatide — full drug profile →
• Placebo

Conditions studied

• Smoking — all drugs for Smoking →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 75, any sex, with Smoking. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips
  Time frame: Week 1 to Week 24

Sponsor's own description

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.

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Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Glucagon-like peptide 1 receptor agonists in substance use disorders: A systematic review of ClinicalTrials.Gov.
   Patil S, Jha N, Jha MK. · · 2026 · PMID 41696398 · DOI 10.1016/j.abrep.2026.100671