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Clinical Trials/NCT07223840
NCT07223840
Recruiting
Phase 2

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 Company59 sites in 3 countries222 target enrollmentStarted: November 3, 2025Last updated:
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InterventionsBrenipatidePlacebo

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
222
Locations
59
Primary Endpoint
Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

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Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Brenipatide

Experimental

Brenipatide administered subcutaneously (SC).

Intervention: Brenipatide (Drug)

Placebo

Placebo Comparator

Placebo administered SC.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips

Time Frame: Week 1 to Week 24

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (59)

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