A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
AstraZeneca
Study ID
NCT07664553
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Elecoglipron — DRUG
    Elecoglipron is administered orally once daily.
  • Placebo — DRUG
    Placebo is administered orally once daily.

Study Details

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)

Key Dates

First listed
Jun 24, 2026
Start date
Jul 8, 2026
Status verified
Jul 2026
Primary completion
May 23, 2028
Completion
May 23, 2028

Study Design

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

Arms

  • Experimental: Elecoglipron dose level 1
    Participants will receive elecoglipron at dose level 1 administered orally once daily.
  • Experimental: Elecoglipron dose level 2
    Participants will receive elecoglipron at dose level 2 administered orally once daily.
  • Placebo Comparator: Placebo
    Participants will receive placebo administered orally once daily.

Primary Outcome Measure

Change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 40 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Research SiteLittle RockArkansas72205-
Research SiteSacramentoCalifornia95821-
Research SiteAuroraColorado80045-
Research SiteDeLandFlorida32720-
Research SiteDoralFlorida33166-
Research SiteOcoeeFlorida34761-
Research SiteDecaturGeorgia30030-
Research SitePotomacMaryland20854-
Research SiteBrooklynNew York11220-
Research SiteCaryNorth Carolina27518-
Research SiteMorehead CityNorth Carolina28557-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteMemphisTennessee38119-
Research SiteHoustonTexas77040-
Research SiteRound RockTexas78681-
Research SiteSan AntonioTexas78231-
Research SiteRentonWashington98057-

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By condition
Type 2 diabetes
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