A Study of LY3437943 in Participants With Type 2 Diabetes

Part of paid clinical trials in Sheffield, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT04867785
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • LY3437943 — DRUG
    Administered SC
  • Dulaglutide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.

Key Dates

Start date
May 13, 2021
Status verified
Jun 2023
Primary completion
Jul 8, 2022
Completion
Oct 27, 2022

Study Design

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

Arms

  • Experimental: 0.5 milligrams (mg) LY3437943
    Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).
  • Experimental: 4 mg LY3437943 (2 mg)
    Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.
  • Experimental: 4 mg LY3437943 (4 mg)
    Participants received 4 mg LY3437943 administered as SC injection QW.
  • Experimental: 8 mg LY3437943 (2 mg)
    Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.
  • Experimental: 8 mg LY3437943 (4 mg)
    Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.
  • Experimental: 12 mg LY3437943 (2 mg)
    Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW.
  • Active Comparator: 1.5 mg Dulaglutide
    Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.
  • Placebo Comparator: Placebo
    Participants received placebo administered as SC injection QW.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 24 Weeks ]

Locations (40)

FacilityCityStateZIPSite coordinators
Syed Research Consultants LlcSheffieldAlabama35660-
San Fernando Valley Health InstituteCanoga ParkCalifornia91304-
Valley Endocrine, FresnoFresnoCalifornia93720-
National Research Institute - Huntington ParkHuntington ParkCalifornia90255-
Catalina Research Institute, LLCMontclairCalifornia91763-
National Research Institute - Panorama CityPanorama CityCalifornia91402-
Anderson Clinical ResearchRedlandsCalifornia92374-
Artemis Institute for Clinical ResearchRiversideCalifornia92503-
Artemis Institute for Clinical ResearchSan DiegoCalifornia92103-
National Research Institute (NRI) - Santa AnaSanta AnaCalifornia92704-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
South Florida Clinical Research InstituteMargateFlorida33063-
ForCare Clinical ResearchTampaFlorida33613-
Encore Medical Research - WestonWestonFlorida33331-
Elite Clinical TrialsBlackfootIdaho83221-
Humphreys Diabetes CenterBoiseIdaho83702-
Rocky Mountain Clinical ResearchIdaho FallsIdaho83404-
Elite Clinical TrialsRexburgIdaho83440-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
Cotton O'Neil ClinicTopekaKansas66606-
Centennial Medical GroupElkridgeMaryland21075-
MediSync Clinical ResearchPetalMississippi39465-
Clinvest Research LLCSpringfieldMissouri65810-
Logan Health ResearchKalispellMontana59901-
Lillestol ResearchFargoNorth Dakota58104-
Intend Research, LLCNormanOklahoma73069-
Heritage Valley Medical Group, Inc.BeaverPennsylvania15009-
Preferred Primary Care PhysiciansPittsburghPennsylvania15236-
Frontier Clinical Research, LLCSmithfieldPennsylvania15478-
Preferred Primary Care PhysiciansUniontownPennsylvania15401-
The Research Center of The UpstateGreenvilleSouth Carolina29607-
Dallas Diabetes Research CenterDallasTexas75230-
Diabetes and Thyroid Center of Fort WorthFort WorthTexas76132-
Endocrine Ips, PllcHoustonTexas77079-
Laila A Hassan, MD, PAHoustonTexas77089-
Southern Endocrinology AssociatesMesquiteTexas75149-
North Hills Family Medicine/North Hills Medical ResearchNorth Richland HillsTexas76180-
Rainier Clinical Research CenterRentonWashington98057-
Universal Research GroupTacomaWashington98405-
The Vancouver ClinicVancouverWashington98664-

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