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RECRUITING
NCT07223840
PHASE2

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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. .

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2025-11-03

Completion Date

2027-02

Last Updated

2026-03-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Brenipatide

Administered SC

DRUG

Placebo

Administered SC

Locations (28)

Woodland Research Northwest

Rogers, Arkansas, United States

Hillcrest Medical Research

DeLand, Florida, United States

TecTum Research

Hollywood, Florida, United States

K2 Medical Research ORLANDO

Maitland, Florida, United States

GTL Medical & Research Group

Miami, Florida, United States

North Georgia Clinical Research

Woodstock, Georgia, United States

Revival Research Institute, LLC

Dearborn, Michigan, United States

Arch Clinical Trials

St Louis, Missouri, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

Rochester Clinical Research, LLC

Rochester, New York, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Circle Clinical Research

Sioux Falls, South Dakota, United States

FutureSearch Trials of Dallas

Dallas, Texas, United States

NextStage Clinical Research_Houston (07) -Menninger Clinic

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Health Research of Hampton Roads, Inc.

Newport News, Virginia, United States

Eastside Research Associates

Redmond, Washington, United States

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, China

Sichuan Provincial People's Hospital

Chengdu, China

2nd Affiliated Hospital Chongqing Medical University

Chongqing, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, China

Taizhou Hospital of Zhejiang Province

Linhai, China

The first affiliated hospital of Ningbo university

Ningbo, China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, China

Miyazaki RC Clinic

Shinagawa-ku, Japan

Samoncho Clinic

Shinjuku, Japan

Higashi Shinjuku Clinic

Tokyo, Japan