A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Part of paid clinical trials in Anaheim, California.

Sponsor
Eli Lilly and Company
Study ID
NCT05048719
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • LY3502970 — DRUG
    Administered orally
  • Dulaglutide — DRUG
    Administered subcutaneously
  • Placebo — DRUG
    Administered orally
  • Placebo — DRUG
    Administered subcutaneously

Study Details

The main purpose of this study is to evaluate the efficacy and safety of LY3502970 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 30 weeks.

Key Dates

Start date
Sep 15, 2021
Status verified
Sep 2023
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022

Study Design

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

Arms

  • Experimental: 3 milligrams (mg) LY3502970
    Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).
  • Experimental: 12 mg LY3502970
    Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.
  • Experimental: 24 mg LY3502970
    Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.
  • Experimental: 36 mg LY3502970 - 1
    Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
  • Experimental: 36 mg LY3502970 - 2
    Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.
  • Experimental: 45 mg LY3502970 - 1
    Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
  • Experimental: 45 mg LY3502970 - 2
    Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.
  • Active Comparator: 1.5 mg Dulaglutide
    Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).
  • Placebo Comparator: Placebo
    Participants received matching placebo.

Primary Outcome Measure

Change From Baseline in HbA1c in LY3502970 as Compared to Placebo [ Time Frame: Baseline, Week 26 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials, LLCAnaheimCalifornia92801-
Velocity Clinical Research, Huntington ParkHuntington ParkCalifornia90255-
Velocity Clinical Research, WestlakeLos AngelesCalifornia90057-
Rancho Cucamonga Clinical ResearchRancho CucamongaCalifornia91730-
Touro University CaliforniaVallejoCalifornia94592-
New West Physicians Clinical ResearchGoldenColorado80401-
Optumcare Colorado Springs - MonumentMonumentColorado80132-
Cotton O'Neil Clinical Research CenterTopekaKansas66606-
Clinvest Research LLCSpringfieldMissouri65807-
Premier ResearchTrentonNew Jersey08611-
Intend Research, LLCNormanOklahoma73069-
Capital Area Research, LLCCamp HillPennsylvania17011-
Family Medical AssociatesLevittownPennsylvania19056-
Tristar Clinical InvestigationsPhiladelphiaPennsylvania19114-
Dallas Diabetes Research CenterDallasTexas75230-
Biopharma Informatic, LLCHoustonTexas77084-
Bandera Family Health CareSan AntonioTexas78249-
Consano Clinical Research, LLCShavano ParkTexas78231-
Capital Clinical Research CenterOlympiaWashington98502-
Eastside Research AssociatesRedmondWashington98052-

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