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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Smoking

In brief

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.

Key facts

Study ID

NCT07223840

Run by

Eli Lilly and Company

People needed

222

Starts

2025-11-03

Expected to finish

2027-02-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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