SmokingPhase 2RENEW-Smk-1NCT07223840
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
A Phase 2 study testing Brenipatide in people with Smoking, run by Eli Lilly and Company at 29 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoking
- What is being tested?
- Brenipatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 3 Nov 2025to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
29 sites in 3 countries
United States18 sites, 17 recruiting
- Recruiting
FutureSearch Trials of Dallas
Dallas, Texas, 75251
214-369-2600
Michael Downing
- Recruiting
Revival Research Institute, LLC
Dearborn, Michigan, 48126
586-276-7453
Abdulhassan Saad
- Completed
Hillcrest Medical Research
DeLand, Florida, 32720
- Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Benji Kurian
- Recruiting
TecTum Research
Hollywood, Florida, 33024
954-990-7649
Juan Rondon
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
832-776-3151
Luba Yammine
- Recruiting
Vector Clinical Trials
Las Vegas, Nevada, 89128
702-750-0000
Ann Childress
- Recruiting
K2 Medical Research ORLANDO
Maitland, Florida, 32751
407-500-5252
Brandon Lenox
- Recruiting
GTL Medical & Research Group
Miami, Florida, 33173
Dunia Llapur Hernandez
- Recruiting
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606
757-591-8100
George Freeman
- Recruiting
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
843-352-6977
Rica Santiago
- Recruiting
Conquest Research - Orlando
Orlando, Florida, 32832
Gilbert Mbeo
- Recruiting
Eastside Research Associates
Redmond, Washington, 98052
425-869-6828
Chad Crystal
- Recruiting
Rochester Clinical Research, LLC
Rochester, New York, 14609
585-288-0890
Leigh Schirmer
- Recruiting
Woodland Research Northwest
Rogers, Arkansas, 72758
Timothy Cook
- Recruiting
Circle Clinical Research
Sioux Falls, South Dakota, 57104
605-215-1159
Sophie Two Hawk
- Recruiting
Arch Clinical Trials
St Louis, Missouri, 63141
Kulsoom Junaid
- Recruiting
North Georgia Clinical Research
Woodstock, Georgia, 30189
678-494-5735
Bram Wieskopf
China8 sites, 8 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020
Lirong Liang
- Recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, 100088
Anning Li
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Haiying Yan
- Recruiting
2nd Affiliated Hospital Chongqing Medical University
Chongqing, 400072
13452414579
Na Li
- Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, 310016
Jinsong Tang
- Recruiting
Taizhou Hospital of Zhejiang Province
Linhai, 317000
Dongqing LV
- Recruiting
The first affiliated hospital of Ningbo university
Ningbo, 315010
Yunxin Ji
- Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, 518053
Lei Rong
Japan3 sites, 3 recruiting
- Recruiting
Miyazaki RC Clinic
Shinagawa-ku, 140-0001
81120023812
Masaki Miyazaki
- Recruiting
Samoncho Clinic
Shinjuku, 160-0017
81120023812
Takahiro Yokoyama
- Recruiting
Higashi Shinjuku Clinic
Tokyo, 169-0072
81120023812
Hiroaki Kondo
About this study
Official title: 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.
- Conditions
- Smoking
- Being tested
- Brenipatide, Placebo
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrenipatideDrug
Also called LY3537031
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Brenipatide | Experimental | Brenipatide administered subcutaneously (SC). Receives: Drug: Brenipatide |
| Placebo | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips
Measured: Week 1 to Week 24
Secondary outcomes (5)
Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips
Measured: Week 1 to Week 24
Mean Change from Baseline in Patient Reported Outcomes
Measured: Baseline, Week 24
Mean Percentage Change in Body Weight
Measured: Baseline, Week 24
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Measured: Baseline up to Week 24
Number of Treatment-emergent Anit-drug Antibodies
Measured: Baseline up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start3 Nov 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223840
- Sponsor's protocol ID
- 27411
- Other IDs
- J2S-MC-GZMO
- Acronym
- RENEW-Smk-1
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07223840
- Acronym / sponsor ID
- RENEW-Smk-1 / 27411
- Conditions
- Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brenipatide | Experimental | Drug: BrenipatideBrenipatide administered subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrenipatideAlso: LY3537031Administered SC | Drug | Brenipatide |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips
Time frame: Week 1 to Week 24
5 secondary outcomes
Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips
Time frame: Week 1 to Week 24
Mean Change from Baseline in Patient Reported Outcomes
Time frame: Baseline, Week 24
Mean Percentage Change in Body Weight
Time frame: Baseline, Week 24
Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline up to Week 24
Number of Treatment-emergent Anit-drug Antibodies
Time frame: Baseline up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (RENEW-Smk-1)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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) study director
Eli Lilly and Company
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brenipatide in people with Smoking, run by Eli Lilly and Company at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips (time frame: Week 1 to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.