A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

Part of paid clinical trials in Huntington Park, California.

Sponsor
Eli Lilly and Company
Study ID
NCT03954834
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.

Key Dates

Start date
Jun 3, 2019
Status verified
Oct 2021
Primary completion
Oct 5, 2020
Completion
Oct 28, 2020

Study Design

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

Arms

  • Experimental: 5 mg Tirzepatide
    Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.
  • Experimental: 10 mg Tirzepatide
    Participants received 10mg of tirzepatide as subcutaneous injection once a week.
  • Experimental: 15 mg Tirzepatide
    Participants received 15mg of tirzepatide as subcutaneous injection once a week.
  • Placebo Comparator: Placebo
    Participants received placebo as subcutaneous injection once a week.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]

Locations (28)

FacilityCityStateZIPSite coordinators
National Research InstituteHuntington ParkCalifornia90255-
National Research InstituteLos AngelesCalifornia90057-
Catalina Research Institute, LLCMontclairCalifornia91763-
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
National Research InstitutePanorama CityCalifornia91402-
Southern California DermatologySanta AnaCalifornia92701-
Clinical Research of South FloridaCoral GablesFlorida33134-
Encore Medical Research, LLCHollywoodFlorida33021-
Axcess Medical ResearchLoxahatchee GrovesFlorida33470-
South Florida Wellness & Clinical Research InstituteMargateFlorida33063-
Suncoast Research Group, LLCMiamiFlorida33135-
Agile Clinical Research TrialsAtlantaGeorgia30328-
Sky Clinical Research NetworkAtlantaGeorgia30331-
Cotton O'Neil ClinicTopekaKansas66606-
Clinical Research ProfessionalsChesterfieldMissouri63005-
StudyMetrix Research, LLCCity of Saint PetersMissouri63303-
Aventiv ResearchColumbusOhio43213-
Intend ResearchNormanOklahoma73069-
The Corvallis Clinic P.C.CorvallisOregon97330-
Heritage Valley Medical Group, Inc.BeaverPennsylvania15009-
Family Medical AssociatesLevittownPennsylvania19056-
Preferred Primary Care PhysiciansPittsburghPennsylvania15236-
Preferred Primary Care PhysiciansUniontownPennsylvania15401-
Dallas Diabetes Endocrine CenterDallasTexas75230-
Clinical Trials of Texas, Inc.San AntonioTexas78229-
Consano Clinical ResearchShavano ParkTexas78231-
Capital Clinical Research CenterOlympiaWashington98502-
Rockwood Clinic Research CenterSpokaneWashington99220-

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