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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

Hillcrest Medical Research
DeLand 4152890, Florida 4155751 32720
Contact:
321-999-7616

TecTum Research
Hollywood 4158928, Florida 4155751 33024
Contact:
954-865-6144

K2 Medical Research ORLANDO
Maitland 4163220, Florida 4155751 32751
Contact:
407-500-5252

North Georgia Clinical Research
Woodstock 4231874, Georgia 4197000 30189
Contact:
678-494-5735

Revival Research Institute, LLC
Dearborn 4990510, Michigan 5001836 48126
Contact:
586-276-7453

Arch Clinical Trials
St Louis 4407066, Missouri 4398678 63141

Vector Clinical Trials
Las Vegas 5506956, Nevada 5509151 89128
Contact:
702-750-0000

Rochester Clinical Research, LLC
Rochester 5134086, New York 5128638 14609
Contact:
585-288-0890

FutureSearch Trials of Dallas
Dallas 4684888, Texas 4736286 75251
Contact:
214-369-2600

Health Research of Hampton Roads, Inc.
Newport News 4776024, Virginia 6254928 23606
Contact:
757-591-8100

Eastside Research Associates
Redmond 5808079, Washington 5815135 98052
Contact:
425-869-6828

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.