A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07667803
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Weight Management

Eligibility Criteria

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

Interventions

  • Elecoglipron — DRUG
    Elecoglipron film-coated tablet once daily
  • Placebo — DRUG
    Placebo matching elecoglipron film-coated tablet once daily

Study Details

This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).

Key Dates

Start date
Jul 6, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2028
Completion
Jul 30, 2029

Study Design

Enrollment
4,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 - Dose 1
    Active IMP
  • Experimental: Arm 2 - Dose 2
    Active IMP
  • Placebo Comparator: Arm 3 - Placebo
    Placebo matching elecoglipron

Primary Outcome Measure

Percent body weight loss [ Time Frame: 72 weeks ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35205-
Research SiteChandlerArizona85225-
Research SiteLincolnCalifornia95648-
Research SiteClearwaterFlorida33765-
Research SiteWoodstockGeorgia30189-
Research SiteIndianapolisIndiana46254-
Research SiteLouisvilleKentucky40213-
Research SiteBaltimoreMaryland21229-
Research SitePotomacMaryland20854-
Research SiteYpsilantiMichigan48197-
Research SiteKansas CityMissouri64114-
Research SiteAlbanyNew York12205-
Research SiteLaureltonNew York11413-
Research SiteGreensboroNorth Carolina27408-
Research SiteRaleighNorth Carolina27609-
Research SiteRocky MountNorth Carolina27804-
Research SiteStatesvilleNorth Carolina28625-
Research SiteDaytonOhio45424-
Research SiteTulsaOklahoma74133-
Research SiteDuBoisPennsylvania15801-
Research SiteNewportPennsylvania17074-
Research SiteGaffneySouth Carolina29340-
Research SiteFranklinTennessee37067-
Research SiteKnoxvilleTennessee37912-
Research SiteDallasTexas75254-
Research SiteMorgantownWest Virginia26501-

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