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

June 10, 2026 updated by: Eli Lilly and Company

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Principal Investigator:
          • Lirong Liang
      • Beijing, China, 100088
        • Recruiting
        • Beijing Anding Hospital - Affiliated Capital University of Medical Science
        • Principal Investigator:
          • Anning Li
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Haiying Yan
      • Chongqing, China, 400072
        • Recruiting
        • 2nd Affiliated Hospital Chongqing Medical University
        • Contact:
          • Phone Number: 13452414579
        • Principal Investigator:
          • Na Li
      • Hangzhou, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Jinsong Tang
      • Linhai, China, 317000
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Principal Investigator:
          • Dongqing LV
      • Ningbo, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
        • Principal Investigator:
          • Yunxin Ji
      • Shenzhen, China, 518053
        • Recruiting
        • The University of Hong Kong-Shenzhen Hospital
        • Principal Investigator:
          • Lei Rong
  • Japan
      • Shinagawa-ku, Japan, 140-0001
        • Recruiting
        • Miyazaki RC Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masaki Miyazaki
      • Shinjuku, Japan, 160-0017
        • Recruiting
        • Samoncho Clinic
        • Principal Investigator:
          • Takahiro Yokoyama
        • Contact:
          • Phone Number: 81120023812
      • Tokyo, Japan, 169-0072
        • Recruiting
        • Higashi Shinjuku Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hiroaki Kondo
  • United States
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Woodland Research Northwest
        • Principal Investigator:
          • Timothy Cook
    • Florida
      • DeLand, Florida, United States, 32720
        • Active, not recruiting
        • Hillcrest Medical Research
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • TecTum Research
        • Principal Investigator:
          • Juan Rondon
        • Contact:
          • Phone Number: 9548656144
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research ORLANDO
        • Contact:
          • Phone Number: 407-500-5252
        • Principal Investigator:
          • Brandon Lenox
      • Miami, Florida, United States, 33173
        • Recruiting
        • GTL Medical & Research Group
        • Principal Investigator:
          • Dunia Llapur Hernandez
    • Georgia
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
        • Principal Investigator:
          • Bram Wieskopf
        • Contact:
          • Phone Number: 6784945735
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Revival Research Institute, LLC
        • Principal Investigator:
          • Abdulhassan Saad
        • Contact:
          • Phone Number: 586-276-7453
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Arch Clinical Trials
        • Principal Investigator:
          • Kulsoom Junaid
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Vector Clinical Trials
        • Principal Investigator:
          • Ann Childress
        • Contact:
          • Phone Number: 7027500000
    • New York
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research, LLC
        • Contact:
          • Phone Number: 585-288-0890
        • Principal Investigator:
          • Leigh Schirmer
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Coastal Carolina Research Center
        • Principal Investigator:
          • Rica Santiago
        • Contact:
          • Phone Number: 8433526977
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Circle Clinical Research
        • Principal Investigator:
          • Sophie Two Hawk
        • Contact:
          • Phone Number: 6052151159
    • Texas
      • Dallas, Texas, United States, 75251
        • Recruiting
        • FutureSearch Trials of Dallas
        • Principal Investigator:
          • Michael Downing
        • Contact:
          • Phone Number: 2143692600
      • Houston, Texas, United States, 77054
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Principal Investigator:
          • Luba Yammine
        • Contact:
          • Phone Number: 8327763151
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Health Research of Hampton Roads, Inc.
        • Contact:
          • Phone Number: 757-591-8100
        • Principal Investigator:
          • George Freeman
    • Washington
      • Redmond, Washington, United States, 98052
        • Recruiting
        • Eastside Research Associates
        • Principal Investigator:
          • Chad Crystal
        • Contact:
          • Phone Number: 4258696828

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC
Experimental: Brenipatide
Brenipatide administered subcutaneously (SC).
Drug: Brenipatide
Administered SC
Other Names:
  • LY3537031

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

October 31, 2025

First Submitted That Met QC Criteria

October 31, 2025

First Posted (Actual)

November 3, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27411
  • J2S-MC-GZMO (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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