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NCT07223840PHASE2Recruiting

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

Eli Lilly and Company

Start Date

11/3/2025

Completion Date

2/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

DRUG

Brenipatide

DRUG

Placebo

Interested in This Trial?

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Conditions

Smoking

Locations

Woodland Research Northwest

Rogers, Arkansas 72758

United States

Hillcrest Medical Research

DeLand, Florida 32720

United States

TecTum Research

Hollywood, Florida 33024

United States

K2 Medical Research ORLANDO

Maitland, Florida 32751

United States

GTL Medical & Research Group

Miami, Florida 33173

United States

North Georgia Clinical Research

Woodstock, Georgia 30189

United States

Revival Research Institute, LLC

Dearborn, Michigan 48126

United States

Arch Clinical Trials

St Louis, Missouri 63141

United States

Vector Clinical Trials

Las Vegas, Nevada 89128

United States

Rochester Clinical Research, LLC

Rochester, New York 14609

United States

Coastal Carolina Research Center

North Charleston, South Carolina 29405

United States

Circle Clinical Research

Sioux Falls, South Dakota 57104

United States

FutureSearch Trials of Dallas

Dallas, Texas 75251

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77054

United States

Health Research of Hampton Roads, Inc.

Newport News, Virginia 23606

United States

Eastside Research Associates

Redmond, Washington 98052

United States

Beijing Chaoyang Hospital, Capital Medical University

Beijing, 100020

China

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, 100088

China

Sichuan Provincial People's Hospital

Chengdu, 610072

China

2nd Affiliated Hospital Chongqing Medical University

Chongqing, 400072

China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, 310016

China

Taizhou Hospital of Zhejiang Province

Linhai, 317000

China

The first affiliated hospital of Ningbo university

Ningbo, 315010

China

The University of Hong Kong-Shenzhen Hospital

Shenzhen, 518053

China

Miyazaki RC Clinic

Shinagawa-ku, 140-0001

Japan

Samoncho Clinic

Shinjuku, 160-0017

Japan

Higashi Shinjuku Clinic

Tokyo, 169-0072

Japan