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

Last updated: April 16, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Brenipatide

Placebo

Clinical Study ID

NCT07223840
27411
J2S-MC-GZMO
  • Ages 18-75
  • All Genders

Study 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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Eligibility Criteria

Inclusion

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 studyand attend required study visits and are willing and able to follow study proceduresas required, such as self-inject study intervention

Exclusion

Exclusion Criteria:

  • Have evidence of any substance use disorder within the past 180 days prior toscreening, except mild alcohol use disorder, mild cannabis use disorder, or tobaccouse 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 haveanswered "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 severerespiratory condition that in the investigator's opinion may pose a risk.

  • Have participated in a clinical study and have received active treatment, or unknownif they received active treatment, within 90 days or 5 half-lives (whichever islonger) before screening

Study Design

Total Participants: 222
Treatment Group(s): 2
Primary Treatment: Brenipatide
Phase: 2
Study Start date:
November 03, 2025
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Beijing Anding Hospital - Affiliated Capital University of Medical Science

    Beijing, 100088
    China

    Active - Recruiting

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, 100020
    China

    Active - Recruiting

  • Beijing Anding Hospital - Affiliated Capital University of Medical Science

    Beijing 1816670, 100088
    China

    Site Not Available

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing 1816670, 100020
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, 610072
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu 1815286, 610072
    China

    Site Not Available

  • 2nd Affiliated Hospital Chongqing Medical University

    Chongqing, 400072
    China

    Active - Recruiting

  • 2nd Affiliated Hospital Chongqing Medical University

    Chongqing 1814906, 400010
    China

    Site Not Available

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, 310016
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou 1808926, 310016
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Linhai, 317000
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province

    Linhai 1803422, 317000
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Linhai 9906214, 317000
    China

    Site Not Available

  • The first affiliated hospital of Ningbo university

    Ningbo, 315010
    China

    Active - Recruiting

  • The first affiliated hospital of Ningbo university

    Ningbo 1799397, 315010
    China

    Site Not Available

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, 518053
    China

    Active - Recruiting

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen 1795565, 518053
    China

    Site Not Available

  • Miyazaki RC Clinic

    Shinagawa-ku, 140-0001
    Japan

    Active - Recruiting

  • Samoncho Clinic

    Shinjuku, 160-0017
    Japan

    Active - Recruiting

  • Samoncho Clinic

    Shinjuku 11790353, 160-0017
    Japan

    Site Not Available

  • Higashi Shinjuku Clinic

    Tokyo, 169-0072
    Japan

    Active - Recruiting

  • Higashi Shinjuku Clinic

    Tokyo 1850147, 169-0072
    Japan

    Site Not Available

  • Woodland Research Northwest

    Rogers, Arkansas 72758
    United States

    Active - Recruiting

  • Woodland Research Northwest

    Rogers 4128894, Arkansas 4099753 72758
    United States

    Site Not Available

  • Hillcrest Medical Research

    DeLand, Florida 32720
    United States

    Active - Recruiting

  • TecTum Research

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • K2 Medical Research ORLANDO

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • GTL Medical & Research Group

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Hillcrest Medical Research

    DeLand 4152890, Florida 4155751 32720
    United States

    Site Not Available

  • TecTum Research

    Hollywood 4158928, Florida 4155751 33024
    United States

    Site Not Available

  • K2 Medical Research ORLANDO

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • GTL Medical & Research Group

    Miami 4164138, Florida 4155751 33173
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Active - Recruiting

  • North Georgia Clinical Research

    Woodstock 4231874, Georgia 4197000 30189
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Revival Research Institute, LLC

    Dearborn, Michigan 48126
    United States

    Active - Recruiting

  • Revival Research Institute, LLC

    Dearborn 4990510, Michigan 5001836 48126
    United States

    Site Not Available

  • Arch Clinical Trials

    St Louis, Missouri 63141
    United States

    Active - Recruiting

  • Arch Clinical Trials

    St Louis 4407066, Missouri 4398678 63141
    United States

    Site Not Available

  • Vector Clinical Trials

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Vector Clinical Trials

    Las Vegas 5506956, Nevada 5509151 89128
    United States

    Site Not Available

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Rochester Clinical Research, LLC

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • Coastal Carolina Research Center

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Coastal Carolina Research Center

    North Charleston 4589387, South Carolina 4597040 29405
    United States

    Site Not Available

  • Circle Clinical Research

    Sioux Falls, South Dakota 57104
    United States

    Active - Recruiting

  • Circle Clinical Research

    Sioux Falls 5231851, South Dakota 5769223 57104
    United States

    Site Not Available

  • FutureSearch Trials of Dallas

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • NextStage Clinical Research_Houston (07) -Menninger Clinic

    Houston, Texas 77035
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77054
    United States

    Active - Recruiting

  • FutureSearch Trials of Dallas

    Dallas 4684888, Texas 4736286 75251
    United States

    Site Not Available

  • NextStage Clinical Research_Houston (07) -Menninger Clinic

    Houston 4699066, Texas 4736286 77035
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Health Research of Hampton Roads, Inc.

    Newport News 4776024, Virginia 6254928 23606
    United States

    Site Not Available

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Active - Recruiting

  • Eastside Research Associates

    Redmond 5808079, Washington 5815135 98052
    United States

    Site Not Available

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