Ireland
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Recruiting Phase 2

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

NCT07223840 · tracked via the Priya Life Science Japan tracker
Phase
Phase 2
Started
2025-11-03
Last updated
2026-09-22

Condition(s) studied

Smoking

Investigational drug(s) / intervention(s)

Brenipatide →Placebo

Brenipatide: Administered SC

Placebo: Administered SC

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (29)

FacilityCityRegionStatus
Woodland Research Northwest Rogers Arkansas Recruiting
Hillcrest Medical Research DeLand Florida Completed
TecTum Research Hollywood Florida Recruiting
K2 Medical Research ORLANDO Maitland Florida Recruiting
GTL Medical & Research Group Miami Florida Recruiting
Conquest Research - Orlando Orlando Florida Recruiting
North Georgia Clinical Research Woodstock Georgia Recruiting
Revival Research Institute, LLC Dearborn Michigan Recruiting
Arch Clinical Trials St Louis Missouri Recruiting
Vector Clinical Trials Las Vegas Nevada Recruiting
Rochester Clinical Research, LLC Rochester New York Recruiting
Coastal Carolina Research Center North Charleston South Carolina Recruiting
Circle Clinical Research Sioux Falls South Dakota Recruiting
FutureSearch Trials of Dallas Dallas Texas Recruiting
Adams Clinical Dallas DeSoto Texas Recruiting
The University of Texas Health Science Center at Houston Houston Texas Recruiting
Health Research of Hampton Roads, Inc. Newport News Virginia Recruiting
Eastside Research Associates Redmond Washington Recruiting
Beijing Chaoyang Hospital, Capital Medical University Beijing China Recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science Beijing China Recruiting
Sichuan Provincial People's Hospital Chengdu China Recruiting
2nd Affiliated Hospital Chongqing Medical University Chongqing China Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Hangzhou China Recruiting
Taizhou Hospital of Zhejiang Province Linhai China Recruiting
The first affiliated hospital of Ningbo university Ningbo China Recruiting
The University of Hong Kong-Shenzhen Hospital Shenzhen China Recruiting
Miyazaki RC Clinic Shinagawa-ku Japan Recruiting
Samoncho Clinic Shinjuku Japan Recruiting
Higashi Shinjuku Clinic Tokyo Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07223840 on ClinicalTrials.gov ↗ ← All trials in Japan