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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Smoking

Treatments: Drug: Placebo; Drug: Brenipatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223840

27411

J2S-MC-GZMO (Other Identifier)

Details and patient eligibility

About

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.

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Enrollment: 222 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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222 participants in 2 patient groups, including a placebo group

Brenipatide

Experimental group

Description:

Brenipatide administered subcutaneously (SC).

Treatment:

Drug: Brenipatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo