Recruiting
Phase 2

Brenipatide

Sponsor:

Eli Lilly and Company

Code:

NCT07223840

Conditions

Smoking

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Brenipatide

Placebo

Study Details

Brief 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.

Conditions

Smoking

Study ID

NCT07223840

Start date

Nov 3, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

222 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Brenipatide

Brenipatide administered subcutaneously (SC).

placebo comparator: Placebo

Placebo administered SC.

Interventions

Brenipatide

Administered SC

Placebo

Administered SC

Primary outcome measure

  • Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips [ Time Frame: Week 1 to Week 24 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Woodland Research Northwest

Recruiting

Rogers, Arkansas, United States, 72758

Principal Investigator:

Timothy Cook

TecTum Research

Recruiting

Hollywood, Florida, United States, 33024

Contacts

954-990-7649

Principal Investigator:

Juan Rondon

K2 Medical Research ORLANDO

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-500-5252

Principal Investigator:

Brandon Lenox

GTL Medical & Research Group

Recruiting

Miami, Florida, United States, 33173

Principal Investigator:

Dunia Llapur Hernandez

North Georgia Clinical Research

Recruiting

Woodstock, Georgia, United States, 30189

Contacts

678-494-5735

Principal Investigator:

Bram Wieskopf

Revival Research Institute, LLC

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

586-276-7453

Principal Investigator:

Abdulhassan Saad

Arch Clinical Trials

Recruiting

St Louis, Missouri, United States, 63141

Principal Investigator:

Kulsoom Junaid

Vector Clinical Trials

Recruiting

Las Vegas, Nevada, United States, 89128

Contacts

702-750-0000

Principal Investigator:

Ann Childress

Rochester Clinical Research, LLC

Recruiting

Rochester, New York, United States, 14609

Contacts

585-288-0890

Principal Investigator:

Leigh Schirmer

Coastal Carolina Research Center

Recruiting

North Charleston, South Carolina, United States, 29405

Contacts

843-352-6977

Principal Investigator:

Rica Santiago

Circle Clinical Research

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

605-215-1159

Principal Investigator:

Sophie Two Hawk

FutureSearch Trials of Dallas

Recruiting

Dallas, Texas, United States, 75251

Contacts

214-369-2600

Principal Investigator:

Michael Downing

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77054

Contacts

832-776-3151

Principal Investigator:

Luba Yammine

Health Research of Hampton Roads, Inc.

Recruiting

Newport News, Virginia, United States, 23606

Contacts

757-591-8100

Principal Investigator:

George Freeman

Eastside Research Associates

Recruiting

Redmond, Washington, United States, 98052

Contacts

425-869-6828

Principal Investigator:

Chad Crystal

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-21.