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

Part of paid clinical trials in Peoria, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07662135
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.
  • 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) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

Key Dates

First listed
Jun 23, 2026
Start date
Jul 6, 2026
Status verified
Jul 2026
Primary completion
Jul 13, 2028
Completion
Jul 13, 2028

Study Design

Enrollment
900 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, in addition to background dapagliflozin 10 mg.
  • Experimental: Elecoglipron dose level 2
    Participants will receive elecoglipron at dose level 2, administered orally once daily, in addition to background dapagliflozin 10 mg.
  • Placebo Comparator: Placebo
    Participants will receive placebo administered orally once daily in addition to background dapagliflozin 10 mg.

Primary Outcome Measure

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

Central Contacts

Locations (30)

FacilityCityStateZIPSite coordinators
Research SitePeoriaArizona85382-
Research SiteSurpriseArizona85374-
Research SiteConcordCalifornia94520-
Research SiteSacramentoCalifornia95821-
Research SiteVictorvilleCalifornia92392-
Research SiteFleming IslandFlorida32003-
Research SiteLauderdale LakesFlorida33313-
Research SiteLeesburgFlorida34748-
Research SiteMiami LakesFlorida33016-
Research SiteOcoeeFlorida34761-
Research SiteOrlandoFlorida32804-
Research SiteBraintreeMassachusetts02184-
Research SiteNew BedfordMassachusetts02740-
Research SiteSaint JosephMichigan49085-
Research SiteSaint PaulMinnesota55117-
Research SiteKansas CityMissouri64111-
Research SiteOmahaNebraska68144-
Research SiteLas VegasNevada89119-
Research SiteAlbuquerqueNew Mexico87102-
Research SiteThe BronxNew York10451-
Research SiteKinstonNorth Carolina28504-
Research SiteRaleighNorth Carolina27609-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteCincinnatiOhio45219-
Research SiteEast ProvidenceRhode Island02914-
Research SiteGaffneySouth Carolina29340-
Research SiteGreenvilleSouth Carolina29605-
Research SiteSan AntonioTexas78257-
Research SiteOgdenUtah84405-
Research SiteArlingtonVirginia22205-

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By condition
Type 2 diabetes
By specialty
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