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
Not Yet 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.
  • 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

Start date
Jul 6, 2026
Status verified
Jun 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 (15)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35801-
Research SiteLos AngelesCalifornia90017-
Research SiteOntarioCalifornia91762-
Research SiteSkokieIllinois60077-
Research SiteZacharyLouisiana70791-
Research SiteLutherville-TimoniumMaryland21093-
Research SiteBostonMassachusetts02115-
Research SiteRaleighNorth Carolina27607-
Research SiteMaumeeOhio43537-
Research SiteKingsportTennessee37660-
Research SiteMcKinneyTexas75069-
Research SiteSouth JordanUtah84095-
Research SiteNewport NewsVirginia23606-
Research SiteRedmondWashington98052-
Research SiteKingwoodWest Virginia26537-

Find similar trials in Huntsville, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Huntsville, ALResearch Site· Los Angeles, CAResearch Site· Ontario, CAResearch Site· Skokie, ILResearch Site· Zachary, LAResearch Site· Lutherville-Timonium, MD

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