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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07662109
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 and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, 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 5, 2028
Completion
Jul 5, 2028

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elecoglipron dose level 1 + dapagliflozin
    Participants will receive elecoglipron at dose level 1 and dapagliflozin, administered orally once daily.
  • Experimental: Elecoglipron dose level 2 + dapagliflozin
    Participants will receive elecoglipron at dose level 2 and dapagliflozin, administered orally once daily.
  • 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.
  • Active Comparator: Elecoglipron-matched placebo + dapagliflozin
    Participants will receive elecoglipron-matched placebo + dapagliflozin, administered orally once daily.

Primary Outcome Measure

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

Central Contacts

Locations (40)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35801-
Research SiteMobileAlabama36608-
Research SiteSheffieldAlabama35660-
Research SiteLittle RockArkansas72205-
Research SiteBakersfieldCalifornia93309-
Research SiteLos AngelesCalifornia90017-
Research SiteOntarioCalifornia91762-
Research SiteLake CityFlorida32055-
Research SiteLakelandFlorida33813-
Research SiteAtlantaGeorgia30315-
Research SiteChicagoIllinois60640-
Research SiteSkokieIllinois60077-
Research SiteEvansvilleIndiana47714-
Research SiteSioux CityIowa51106-
Research SiteZacharyLouisiana70791-
Research SiteAnnapolisMaryland21401-
Research SiteLutherville-TimoniumMaryland21093-
Research SiteOxon HillMaryland20745-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02115-
Research SiteTroyMichigan48098-
Research SiteRidgelandMississippi39157-
Research SiteElkhornNebraska68022-
Research SiteAlbuquerqueNew Mexico87112-
Research SiteBrooklynNew York11201-
Research SiteRaleighNorth Carolina27607-
Research SiteBeachwoodOhio44122-
Research SiteMaumeeOhio43537-
Research SiteNormanOklahoma73069-
Research SiteKingsportTennessee37660-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75230-
Research SiteMcKinneyTexas75069-
Research SiteParisTexas75462-
Research SiteSan AntonioTexas78229-
Research SiteSouth JordanUtah84095-
Research SiteArlingtonVirginia22205-
Research SiteNewport NewsVirginia23606-
Research SiteRedmondWashington98052-
Research SiteKingwoodWest Virginia26537-

Find similar trials in Huntsville, AL

Nationwide
Type 2 diabetes trialsEndocrinology trialsMetabolic health trialsWeight loss trials
By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss

Related Studies