Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06579105
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo (placebo matching AZD5004 film-coated tablet) — DRUG
    Placebo film-coated tablet (matching AZD5004)
  • AZD5004 — DRUG
    AZD5004 film-coated tablet, once daily during 26 weeks
  • Semaglutide — DRUG
    3-14 mg tablets of Semaglutide

Study Details

This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator.

Key Dates

Start date
Oct 8, 2024
Status verified
Jan 2026
Primary completion
Dec 19, 2025
Completion
Dec 19, 2025

Study Design

Enrollment
406 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants will receive xx mg once daily dose of AZD5004
  • Experimental: Arm 2
    Participants will receive xx mg once daily dose of AZD5004
  • Experimental: Arm 3
    Participants will receive xx mg once daily dose of AZD5004
  • Experimental: Arm 4
    Participants will receive xx mg once daily dose of AZD5004
  • Experimental: Arm 5
    Participants will receive xx mg once daily dose of AZD5004
  • Experimental: Arm 6
    Participants will receive xx mg once daily dose of AZD5004
  • Active Comparator: Arm 7
    Participants will receive once daily dose of Semaglutide as active comparator
  • Placebo Comparator: Arm 8
    Participants will receive matching placebo for each AZD5004 arm

Primary Outcome Measure

Change in HbA1c [ Time Frame: Baseline to Week 26 ]

Locations (50)

FacilityCityStateZIPSite coordinators
Research SiteMobileAlabama36608-
Research SiteSheffieldAlabama35660-
Research SiteVestavia HillsAlabama35216-
Research SiteTucsonArizona85710-
Research SiteLittle RockArkansas72205-
Research SiteLong BeachCalifornia90815-
Research SiteLos AngelesCalifornia90017-
Research SiteNewport BeachCalifornia92660-
Research SiteSacramentoCalifornia95821-
Research SiteWaterburyConnecticut06708-
Research SiteLake CityFlorida32055-
Research SiteLargoFlorida33777-
Research SiteOcoeeFlorida34761-
Research SiteOrlandoFlorida32804-
Research SiteDecaturGeorgia30030-
Research SiteSavannahGeorgia31406-
Research SiteLombardIllinois60148-
Research SitePotomacMaryland20854-
Research SiteBostonMassachusetts02115-
Research SiteRoslindaleMassachusetts02131-
Research SiteFarmington HillsMichigan48334-
Research SiteGulfportMississippi39503-
Research SiteKansas CityMissouri64111-
Research SiteOmahaNebraska68134-
Research SiteLas VegasNevada89109-
Research SiteAlbuquerqueNew Mexico87107-
Research SiteBinghamtonNew York13905-
Research SiteDurhamNorth Carolina27701-
Research SiteGreensboroNorth Carolina27408-
Research SiteRocky MountNorth Carolina27804-
Research SiteStatesvilleNorth Carolina28625-
Research SiteWilmingtonNorth Carolina28401-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteFargoNorth Dakota58104-
Research SiteBeachwoodOhio44122-
Research SiteCincinnatiOhio45219-
Research SiteMedfordOregon97504-
Research SiteWest ChesterPennsylvania19380-
Research SiteGaffneySouth Carolina29340-
Research SiteBristolTennessee37620-
Research SiteAbileneTexas79606-
Research SiteDallasTexas75230-
Research SiteEl PasoTexas79935-
Research SiteHoustonTexas77004-
Research SiteWest JordanUtah84088-
Research SiteCharlottesvilleVirginia22911-
Research SiteManassasVirginia20110-
Research SiteNorfolkVirginia23504-
Research SiteSeattleWashington98105-
Research SiteKingwoodWest Virginia26537-

Find similar trials in Mobile, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Mobile, ALResearch Site· Sheffield, ALResearch Site· Vestavia Hills, ALResearch Site· Tucson, AZResearch Site· Little Rock, ARResearch Site· Long Beach, CA

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