A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07662044
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Elecoglipron — DRUG
    Elecoglipron is administered orally once daily.
  • Dapagliflozin — DRUG
    Dapagliflozin administered orally once daily.
  • Elecoglipron-matched placebo — DRUG
    A placebo matching elecoglipron, administered orally once daily.
  • Dapagliflozin-matched placebo — DRUG
    A placebo matching dapagliflozin, administered orally once daily.

Study Details

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Key Dates

First listed
Jun 23, 2026
Start date
Jul 6, 2026
Status verified
Jul 2026
Primary completion
Jul 14, 2028
Completion
Jul 14, 2028

Study Design

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

Arms

  • Experimental: Elecoglipron dose level 1 + dapagliflozin-matched placebo
    Participants will receive elecoglipron at dose level 1 and dapagliflozin-matched placebo, administered orally once daily.
  • Experimental: Elecoglipron dose level 2 + dapagliflozin-matched placebo
    Participants will receive elecoglipron at dose level 2 and dapagliflozin-matched placebo, administered orally once daily.
  • Experimental: Elecoglipron (one of the studied dose levels) + dapagliflozin
    Participants will receive elecoglipron at one of the study dose levels in combination with dapagliflozin, administered orally once daily.
  • Placebo Comparator: Elecoglipron-matched placebo + dapagliflozin-matched placebo
    Participants will receive elecoglipron-matched placebo and dapagliflozin-matched placebo, administered orally once daily.

Primary Outcome Measure

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

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35233-
Research SiteDaphneAlabama36526-
Research SiteLomitaCalifornia90717-
Research SiteLos AlamitosCalifornia90720-
Research SiteSan DiegoCalifornia92111-
Research SiteWalnut CreekCalifornia94598-
Research SiteEnglewoodColorado80110-
Research SiteBridgeportConnecticut06606-
Research SiteJacksonvilleFlorida32256-
Research SiteOrlandoFlorida32801-
Research SiteConyersGeorgia30094-
Research SiteDecaturGeorgia30030-
Research SiteHinesvilleGeorgia31313-
Research SiteEl DoradoKansas67042-
Research SiteNewtonKansas67114-
Research SiteLexingtonKentucky40509-
Research SiteCovingtonLouisiana70433-
Research SiteBowieMaryland20715-
Research SiteSouthfieldMichigan48075-
Research SiteKansas CityMissouri64111-
Research SiteSt LouisMissouri63141-
Research SiteLas VegasNevada89119-
Research SiteAndersonSouth Carolina29621-
Research SiteKnoxvilleTennessee37909-
Research SiteFort WorthTexas76135-
Research SiteIrvingTexas75061-
Research SiteRentonWashington98057-

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