A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT06660173
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

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

Interventions

  • Maridebart Cafraglutide — DRUG
    Solution for subcutaneous injection.
  • Placebo — DRUG
    Solution for subcutaneous injection.

Study Details

The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.

Key Dates

First listed
Oct 28, 2024
Start date
Nov 7, 2024
Status verified
Sep 2026
Primary completion
Oct 6, 2025
Completion
Nov 10, 2026

Study Design

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

Arms

  • Experimental: Maridebart Cafraglutide
    Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.
  • Placebo Comparator: Placebo
    Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week Part 1 treatment period and meet specific criteria will have the option to begin an exploratory part 2 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Participants who complete the 24-week Part 2 treatment period and meet specific criteria will have the option to begin an exploratory part 3 where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.

Primary Outcome Measure

Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline to Week 24 ]

Locations (28)

FacilityCityStateZIPSite coordinators
Accel Research Site - Birmingham Clinical Research UnitBirminghamAlabama35216-
Anaheim Clinical TrialsAnaheimCalifornia92801-
Hope Clinical Research LLCCanoga ParkCalifornia91303-
Orange County Research CenterLake ForestCalifornia92630-
San Jose Clinical TrialsSan JoseCalifornia95128-
Northeast Research Institute - NeriFleming IslandFlorida32003-
New Horizon Research CenterMiamiFlorida33165-
Florida Institute for Clinical ResearchOrlandoFlorida32825-
Conquest Research - Winter ParkWinter ParkFlorida32789-
Accel Research Site - NeurostudiesDecaturGeorgia30030-
Cedar Crosse Research and Health CareChicagoIllinois60607-
Tandem Clinical Research - MarreroMarreroLouisiana70072-
DM Clinical - DetroitSouthfieldMichigan48076-
Montana Medical ResearchMissoulaMontana59808-
Physicians EastGreenvilleNorth Carolina27834-
Diabetes and Endocrinology Associates of Stark County IncCantonOhio44718-
Alliance for Multispecialty ResearchNormanOklahoma73069-
Trial Management Associates - Myrtle BeachMyrtle BeachSouth Carolina29572-
FutureSearch Trials of NeurologyAustinTexas78731-
Velocity Clinical Research - DallasDallasTexas75230-
DM Clinical Research - Cyfair Clinical Research CenterHoustonTexas77065-
Southern Endocrinology Associates PAMesquiteTexas75149-
Be Well Clinical StudiesRound RockTexas78681-
Diabetes and Glandular Disease ClinicSan AntonioTexas78229-
DM Clinical Research - Martin Diagnostic ClinicTomballTexas77375-
Charlottesville Medical Research CenterCharlottesvilleVirginia22911-
Manassas Clinical Research Center IncManassasVirginia20110-
Eastside Research Associates Health ResearchRedmondWashington98052-

Find similar trials in Birmingham, AL

By research site
Accel Research Site - Birmingham Clinical Research Unit· Birmingham, ALAnaheim Clinical Trials· Anaheim, CAHope Clinical Research LLC· Canoga Park, CAOrange County Research Center· Lake Forest, CASan Jose Clinical Trials· San Jose, CANortheast Research Institute - Neri· Fleming Island, FL

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