A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT04166773
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).

Key Dates

Start date
Nov 19, 2019
Status verified
Jan 2025
Primary completion
Dec 11, 2023
Completion
Jan 10, 2024

Study Design

Enrollment
190 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5 mg Tirzepatide
    5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
  • Experimental: 10 mg Tirzepatide
    10 mg tirzepatide administered SC once a week.
  • Experimental: 15 mg Tirzepatide
    15 mg tirzepatide administered SC once a week.
  • Placebo Comparator: Placebo
    Placebo administered SC once a week.

Primary Outcome Measure

Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology [ Time Frame: Week 52 ]

Locations (47)

FacilityCityStateZIPSite coordinators
University of Alabama-The Kirklin ClinicBirminghamAlabama35205-
Synexus Clinical Research US, Inc.ChandlerArizona85224-
Fresno Clinical Research CenterFresnoCalifornia93720-
National Research Institute - Huntington ParkHuntington ParkCalifornia90255-
UCSD - Altman Clinical and Translational Research Institute (ACTRI)La JollaCalifornia92037-
National Research Institute - WilshireLos AngelesCalifornia90057-
Catalina Research Institute, LLCMontclairCalifornia91763-
Diabetes Medical Center of CaliforniaNorthridgeCalifornia91325-
Velocity Clinical Research, Panorama CityPanorama CityCalifornia91402-
Inland Empire Clinical Trials, LLCRialtoCalifornia92377-
Velocity Clinical Research, Santa AnaSanta AnaCalifornia92704-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Alliance for Multispecialty Research, LLCCoral GablesFlorida33134-
Research Centers of America ( Hollywood )HollywoodFlorida33024-
East Coast Institute for Research, LLCJacksonvilleFlorida32204-
IHS Health ResearchKissimmeeFlorida34741-
Accel Research Sites - Maitland Clinical Research UnitMaitlandFlorida32751-
Clinical Pharmacology of MiamiMiamiFlorida33014-
Synexus Clinical Research US, Inc.OrlandoFlorida32806-
The Center for Digestive HealthOrlandoFlorida32803-
Synexus Clinical Research US, Inc.The VillagesFlorida32162-
Synexus Clinical ResearchChicagoIllinois60602-
Indiana University Health HospitalIndianapolisIndiana46202-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
Cotton O'Neil Clinical Research CenterTopekaKansas66606-
Alliance for Multispecialty Research, LLCWichitaKansas67207-
Tandem Clinical ResearchMarreroLouisiana70072-
The National Diabetes & Obesity Research InstituteBiloxiMississippi39532-
Southern Therapy and Advanced Research (STAR) LLCJacksonMississippi39216-
Buffalo Clinical and Translational Research CenterBuffaloNew York14203-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
NYU Langone HealthNew YorkNew York10016-
Montefiore Medical CenterThe BronxNew York10467-
Diabetes & Endocrinology Consultants, PCMorehead CityNorth Carolina28557-
Geisinger Medical CenterDanvillePennsylvania17822-
WR-Clinsearch, LLCChattanoogaTennessee37421-
Dallas Diabetes Research CenterDallasTexas75230-
Liver Center of Texas, PLLCDallasTexas75234-7858-
Radiant Research - Dallas NorthDallasTexas75231-
Texoma Medical CenterDenisonTexas75020-
Texas Diabetes & Endocrinology, P.A.Round RockTexas78681-
American Research Corporation at Texas Liver InstituteSan AntonioTexas78215-
Endeavor Clinical TrialsSan AntonioTexas78240-
Synexus Clinical Research US, Inc.San AntonioTexas78229-
National Clinical Research, IncRichmondVirginia23294-
Virginia Commonwealth University (VCU) Medical CenterRichmondVirginia23298-
Harborview Medical Center/University of WashingtonSeattleWashington98104-

Find similar trials in Birmingham, AL

By research site
University of Alabama-The Kirklin Clinic· Birmingham, ALSynexus Clinical Research US, Inc.· Chandler, AZFresno Clinical Research Center· Fresno, CANational Research Institute - Huntington Park· Huntington Park, CAUCSD - Altman Clinical and Translational Research Institute (ACTRI)· La Jolla, CANational Research Institute - Wilshire· Los Angeles, CA

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