A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse

Part of paid clinical trials in Rogers, Arkansas.

Sponsor
Eli Lilly and Company
Study ID
NCT07223840
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Smoking

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Brenipatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

First listed
Nov 3, 2025
Start date
Nov 3, 2025
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brenipatide
    Brenipatide administered subcutaneously (SC).
  • Placebo Comparator: Placebo
    Placebo administered SC.

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 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (16)

FacilityCityStateZIPSite coordinators
Woodland Research NorthwestRogersArkansas72758
Timothy Cook (PRINCIPAL_INVESTIGATOR)
Hillcrest Medical ResearchDeLandFlorida32720-
TecTum ResearchHollywoodFlorida33024
9548656144
Juan Rondon (PRINCIPAL_INVESTIGATOR)
K2 Medical Research ORLANDOMaitlandFlorida32751
407-500-5252
Brandon Lenox (PRINCIPAL_INVESTIGATOR)
GTL Medical & Research GroupMiamiFlorida33173
Dunia Llapur Hernandez (PRINCIPAL_INVESTIGATOR)
North Georgia Clinical ResearchWoodstockGeorgia30189
6784945735
Bram Wieskopf (PRINCIPAL_INVESTIGATOR)
Revival Research Institute, LLCDearbornMichigan48126
586-276-7453
Abdulhassan Saad (PRINCIPAL_INVESTIGATOR)
Arch Clinical TrialsSt LouisMissouri63141
Kulsoom Junaid (PRINCIPAL_INVESTIGATOR)
Vector Clinical TrialsLas VegasNevada89128
7027500000
Ann Childress (PRINCIPAL_INVESTIGATOR)
Rochester Clinical Research, LLCRochesterNew York14609
585-288-0890
Leigh Schirmer (PRINCIPAL_INVESTIGATOR)
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405
8433526977
Rica Santiago (PRINCIPAL_INVESTIGATOR)
Circle Clinical ResearchSioux FallsSouth Dakota57104
6052151159
Sophie Two Hawk (PRINCIPAL_INVESTIGATOR)
FutureSearch Trials of DallasDallasTexas75251
2143692600
Michael Downing (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77054
8327763151
Luba Yammine (PRINCIPAL_INVESTIGATOR)
Health Research of Hampton Roads, Inc.Newport NewsVirginia23606
757-591-8100
George Freeman (PRINCIPAL_INVESTIGATOR)
Eastside Research AssociatesRedmondWashington98052
4258696828
Chad Crystal (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rogers, AR

By research site
Woodland Research Northwest· Rogers, ARHillcrest Medical Research· DeLand, FLTecTum Research· Hollywood, FLK2 Medical Research ORLANDO· Maitland, FLGTL Medical & Research Group· Miami, FLNorth Georgia Clinical Research· Woodstock, GA

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