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

Not Applicable

Not yet recruiting

• Conditions: Smoking
• Interventions: Drug: Brenipatide; Drug: Placebo

• Registration Number: NCT07223840
• Lead Sponsor: Eli Lilly and Company

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.

.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-10-31
• Study First Submitted QC: 2025-10-31
• Status Verified: 2025-11
• Study Start: 2025-11-01
• Study First Posted: 2025-11-03
• Last Update Submitted: 2025-11-03
• Last Update Posted: 2025-11-04
• Primary Completion: 2027-02
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 222

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brenipatide	Brenipatide	Brenipatide administered subcutaneously (SC).
Placebo	Placebo	Placebo administered SC.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips	Week 1 to Week 24
Mean Change from Baseline in Patient Reported Outcomes	Baseline, Week 24
Mean Percentage Change in Body Weight	Baseline, Week 24
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide	Baseline up to Week 24
Number of Treatment-emergent Anit-drug Antibodies	Baseline up to Week 24

Trial Locations

Locations (26)

Coastal Carolina Research Center; 🇺🇸 North Charleston, South Carolina, United States

Circle Clinical Research; 🇺🇸 Sioux Falls, South Dakota, United States

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

Scroll for more (16 remaining)