Language: BG BG
← Back to results
Recruiting Phase 2 NCT07223840

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

Phase 2 – studying effectiveness and dosage
Conditions: Smoking

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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. .
Who can participate
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
Interventions
Brenipatide
DRUG
Placebo
DRUG
Locations 27
China (8)
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing
Sichuan Provincial People's Hospital
Chengdu
2nd Affiliated Hospital Chongqing Medical University
Chongqing
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou
Taizhou Hospital of Zhejiang Province
Linhai
The first affiliated hospital of Ningbo university
Ningbo
The University of Hong Kong-Shenzhen Hospital
Shenzhen
Japan (3)
Miyazaki RC Clinic
Shinagawa-ku
Samoncho Clinic
Shinjuku
Higashi Shinjuku Clinic
Tokyo
United States (16)
FutureSearch Trials of Dallas
Dallas , Texas
Revival Research Institute, LLC
Dearborn , Michigan
Hillcrest Medical Research
DeLand , Florida
TecTum Research
Hollywood , Florida
The University of Texas Health Science Center at Houston
Houston , Texas
Vector Clinical Trials
Las Vegas , Nevada
K2 Medical Research ORLANDO
Maitland , Florida
GTL Medical & Research Group
Miami , Florida
Health Research of Hampton Roads, Inc.
Newport News , Virginia
Coastal Carolina Research Center
North Charleston , South Carolina
Eastside Research Associates
Redmond , Washington
Rochester Clinical Research, LLC
Rochester , New York
Woodland Research Northwest
Rogers , Arkansas
Circle Clinical Research
Sioux Falls , South Dakota
Arch Clinical Trials
St Louis , Missouri
North Georgia Clinical Research
Woodstock , Georgia
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
03.11.2025
Completion date
01.02.2027
Registry ID
NCT07223840
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.