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

NCT07223840 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 27411J2S-MC-GZMO
• Study Type: interventional
• Target: 222
• Locations: 3 countries
• Sites: 27

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

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

  Week 1 to Week 24

Secondary Outcomes (5)

• 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

Study Arms (2)

Brenipatide

EXPERIMENTAL

Brenipatide administered subcutaneously (SC).

Drug: Brenipatide

Placebo

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

Placebo DRUG

Administered SC

Placebo

Brenipatide DRUG

Administered SC

Also known as: LY3537031

Brenipatide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (27)

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

RECRUITING

Hillcrest Medical Research

DeLand, Florida, 32720, United States

ACTIVE NOT RECRUITING

TecTum Research

Hollywood, Florida, 33024, United States

RECRUITING

K2 Medical Research ORLANDO

Maitland, Florida, 32751, United States

RECRUITING

GTL Medical & Research Group

Miami, Florida, 33173, United States

RECRUITING

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

RECRUITING

Revival Research Institute, LLC

Dearborn, Michigan, 48126, United States

RECRUITING

Arch Clinical Trials

St Louis, Missouri, 63141, United States

RECRUITING

Vector Clinical Trials

Las Vegas, Nevada, 89128, United States

RECRUITING

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

RECRUITING

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

RECRUITING

Circle Clinical Research

Sioux Falls, South Dakota, 57104, United States

RECRUITING

FutureSearch Trials of Dallas

Dallas, Texas, 75251, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

RECRUITING

Health Research of Hampton Roads, Inc.

Newport News, Virginia, 23606, United States

RECRUITING

Eastside Research Associates

Redmond, Washington, 98052, United States

RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, 100020, China

RECRUITING

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, 100088, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, 610072, China

RECRUITING

2nd Affiliated Hospital Chongqing Medical University

Chongqing, 400072, China

RECRUITING

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, 310016, China

RECRUITING

Taizhou Hospital of Zhejiang Province

Linhai, 317000, China

RECRUITING

The first affiliated hospital of Ningbo university

Ningbo, 315010, China

RECRUITING

The University of Hong Kong-Shenzhen Hospital

Shenzhen, 518053, China

RECRUITING

Miyazaki RC Clinic

Shinagawa-ku, 140-0001, Japan

RECRUITING

Samoncho Clinic

Shinjuku, 160-0017, Japan

RECRUITING

Higashi Shinjuku Clinic

Tokyo, 169-0072, Japan

RECRUITING

Related Links

• A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (RENEW-Smk-1)

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 3, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

Locations

JP (3); US (16); CN (8)