Print

Purpose

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. .

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Brenipatide 		Brenipatide administered subcutaneously (SC).
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
Placebo Comparator
Placebo 		Placebo administered SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston 4699066, Texas 4736286 77054
Contact:
832-776-3151

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.