Brenipatide to help adults who recently quit smoking avoid relapse

A Phase 2, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for Reduction in Risk of Relapse to Cigarette Smoking in Adults (RENEW-Smk-1)

This trial will see if brenipatide helps adults who recently quit smoking stay off cigarettes better than a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eli Lilly and Company (Industry-sponsored)
• Locations: 27 sites (Rogers, Arkansas and 26 other locations)
• Trial ID: NCT07223840 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2 trial tests brenipatide in adults who have recently quit smoking to reduce the risk of relapse. Participants receive brenipatide or matching placebo during a 24-week treatment period, with a total participation time of about 34 weeks including screening and an 8-week safety follow-up. The protocol involves up to 17 clinic visits and requires participants to be willing to self-inject the study medication and follow study procedures. The study excludes people with recent substance use disorders (except some mild cases), recent suicidal ideation/behavior, or severe respiratory disease and is sponsored by Eli Lilly at three U.S. research sites.

Who should consider this trial

Good fit: Adults who have recently quit smoking, are motivated to stay quit, can attend clinic visits for about 34 weeks, and are willing and able to self-inject the study medication, without recent substance use disorder or severe respiratory disease, are ideal candidates.

Not a fit: People with recent substance use disorders (other than mild alcohol/cannabis), recent suicidal ideation or behavior, severe chronic respiratory disease, or those unwilling to self-inject or attend multiple visits are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, brenipatide could help more people maintain smoking abstinence and reduce the chance of returning to cigarettes.

How similar studies have performed: While behavioral programs and some medications can reduce relapse risk, using brenipatide specifically for relapse prevention is a novel approach with limited prior clinical data.

Eligibility criteria

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

Where this trial is running

Rogers, Arkansas and 26 other locations

• Woodland Research Northwest — Rogers, Arkansas, United States (Recruiting)
• Hillcrest Medical Research — DeLand, Florida, United States (Recruiting)
• TecTum Research — Hollywood, Florida, United States (Recruiting)
• K2 Medical Research ORLANDO — Maitland, Florida, United States (Recruiting)
• GTL Medical & Research Group — Miami, Florida, United States (Recruiting)
• North Georgia Clinical Research — Woodstock, Georgia, United States (Recruiting)
• Revival Research Institute, LLC — Dearborn, Michigan, United States (Recruiting)
• Arch Clinical Trials — St Louis, Missouri, United States (Recruiting)
• Vector Clinical Trials — Las Vegas, Nevada, United States (Recruiting)
• Rochester Clinical Research, LLC — Rochester, New York, United States (Recruiting)
• Coastal Carolina Research Center — North Charleston, South Carolina, United States (Recruiting)
• Circle Clinical Research — Sioux Falls, South Dakota, United States (Recruiting)
• FutureSearch Trials of Dallas — Dallas, Texas, United States (Recruiting)
• The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
• Health Research of Hampton Roads, Inc. — Newport News, Virginia, United States (Recruiting)
• Eastside Research Associates — Redmond, Washington, United States (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)

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Conditions Smoking