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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) (J2S-MC-GZMO)

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (J2S-MC-GZMO)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

Dec. 15, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Smoking

DRUG: Brenipatide(Other Name: LY3537031)
Administered SC
DRUG: Placebo
Administered SC

(Study Arms)
Experimental: Brenipatide
Brenipatide administered subcutaneously (SC).
Interventions:
Drug: Brenipatide
Placebo Comparator: Placebo
Placebo administered SC.
Interventions:
Drug: Placebo

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

+81-3-6868-7022

Oct. 17, 2025

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.

United States/China