A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
NCT ID: NCT07223840
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
222 participants
INTERVENTIONAL
2025-11-30
2027-02-28
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brenipatide
Brenipatide administered subcutaneously (SC).
Brenipatide
Administered SC
Placebo
Placebo administered SC.
Placebo
Administered SC
Interventions
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Brenipatide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Hillcrest Medical Research
DeLand, Florida, United States
TecTum Research
Hollywood, Florida, United States
K2 Medical Research ORLANDO
Maitland, Florida, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, 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
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
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Related Links
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A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (RENEW-Smk-1)
Other Identifiers
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J2S-MC-GZMO
Identifier Type: OTHER
Identifier Source: secondary_id
27411
Identifier Type: -
Identifier Source: org_study_id