RENEW-Smk-1

RecruitingPhase 2

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)

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

222

Study population

Alcohol / substance use

Eligibility highlights

Primary endpoint

•Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07223840

Org study ID27411

Secondary IDJ2S-MC-GZMOEli Lilly and Company

Timeline

Milestones

Study first posted2025-11-03actual

Study start2025-11-03actual

Last update posted2026-09-22actual

Primary completion2027-02estimated (month precision)

Study completion2027-02estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Alcohol / substance use

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Mean Percentage Change in Body Weight

Time frame:Baseline, Week 24

percent change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

Time frame:Baseline up to Week 24

concentration, descriptive

Secondary/protocol endpoint

Number of Treatment-emergent Anit-drug Antibodies

Time frame:Baseline up to Week 24

event count, event

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

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

Time frame:Week 1 to Week 24

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips

Time frame:Week 1 to Week 24

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Mean Change from Baseline in Patient Reported Outcomes

Time frame:Baseline, Week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.