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A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse

RecruitingPhase 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)

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 222 · Started: Nov 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07223840

Locations in the U.S.

ArkansasWoodland Research Northwest, Rogers
FloridaTecTum Research, Hollywood
K2 Medical Research ORLANDO, Maitland
GTL Medical & Research Group, Miami
Conquest Research - Orlando, Orlando
GeorgiaNorth Georgia Clinical Research, Woodstock
MichiganRevival Research Institute, LLC, Dearborn
MissouriArch Clinical Trials, St Louis
NevadaVector Clinical Trials, Las Vegas
New YorkRochester Clinical Research, LLC, Rochester
South CarolinaCoastal Carolina Research Center, North Charleston
South DakotaCircle Clinical Research, Sioux Falls
TexasFutureSearch Trials of Dallas, Dallas
Adams Clinical Dallas, DeSoto
The University of Texas Health Science Center at Houston, Houston
VirginiaHealth Research of Hampton Roads, Inc., Newport News
WashingtonEastside Research Associates, Redmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.