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RecruitingPhase 2

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

Eli Lilly and Company · NCT07223840

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
222
US sites recruiting
17
Study start
November 3, 2025
Record last updated
September 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Brenipatide; Placebo

Conditions: Smoking

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Woodland Research Northwest

    Rogers, AR 72758

    Site contact: Timothy Cook

  • TecTum Research

    Hollywood, FL 33024

    Site contact: 954-990-7649

  • K2 Medical Research ORLANDO

    Maitland, FL 32751

    Site contact: 407-500-5252

  • GTL Medical & Research Group

    Miami, FL 33173

    Site contact: Dunia Llapur Hernandez

  • Conquest Research - Orlando

    Orlando, FL 32832

    Site contact: Gilbert Mbeo

  • North Georgia Clinical Research

    Woodstock, GA 30189

    Site contact: 678-494-5735

  • Revival Research Institute, LLC

    Dearborn, MI 48126

    Site contact: 586-276-7453

  • Arch Clinical Trials

    St Louis, MO 63141

    Site contact: Kulsoom Junaid

  • Vector Clinical Trials

    Las Vegas, NV 89128

    Site contact: 702-750-0000

  • Rochester Clinical Research, LLC

    Rochester, NY 14609

    Site contact: 585-288-0890

  • Coastal Carolina Research Center

    North Charleston, SC 29405

    Site contact: 843-352-6977

  • Circle Clinical Research

    Sioux Falls, SD 57104

    Site contact: 605-215-1159

  • FutureSearch Trials of Dallas

    Dallas, TX 75251

    Site contact: 214-369-2600

  • Adams Clinical Dallas

    DeSoto, TX 75115

    Site contact: Benji Kurian

  • The University of Texas Health Science Center at Houston

    Houston, TX 77054

    Site contact: 832-776-3151

  • Health Research of Hampton Roads, Inc.

    Newport News, VA 23606

    Site contact: 757-591-8100

  • Eastside Research Associates

    Redmond, WA 98052

    Site contact: 425-869-6828

Study contacts (from the official record)

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
  • Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com
All smoking & vaping studies in Arkansas →
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and… (NCT07223840) | Bored Studies