Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes (MARITIME-T2D-3)
A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-mail: medinfo@amgen.com
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Y 3W2
- Rekruttering
- Dr T G Elliott Incorporated - BC Diabetes
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California
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San Diego, California, Forenede Stater, 92120
- Rekruttering
- Acclaim Clinical Research
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Florida
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Miami, Florida, Forenede Stater, 33155
- Rekruttering
- Bioclinical Research Alliance
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Miami Lakes, Florida, Forenede Stater, 33016
- Rekruttering
- Indago Research and Health Center
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Pompano Beach, Florida, Forenede Stater, 33060
- Rekruttering
- Clinical Research Center Of Florida
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Winter Park, Florida, Forenede Stater, 32789
- Rekruttering
- Conquest Research - Winter Park
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Virginia
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Arlington, Virginia, Forenede Stater, 22205
- Rekruttering
- Virginia Nephrology Group
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Washington
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Redmond, Washington, Forenede Stater, 98052
- Rekruttering
- Eastside Research Associates Health Research
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
- Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.
- Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m^2) at screening.
Exclusion Criteria:
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Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.
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Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
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Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
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One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
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History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
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Self-reported change in body weight > 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
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Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:
- liposuction and/or abdominoplasty that was performed > 1 year before screening.
- laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed > 1 year before screening.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Maridebart cafraglutide
Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. |
Administered subcutaneously.
Andre navne:
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Aktiv komparator: Semaglutide
Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. |
Administered subcutaneously. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Tidsramme: Baseline to Week 68
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Baseline to Week 68
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Plasma Concentration of Maridebart Cafraglutide at Week 68
Tidsramme: Week 68
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Week 68
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Change from Baseline in HbA1c at week 68 [Superiority]
Tidsramme: Baseline to Week 68
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Baseline to Week 68
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Percent Change from Baseline in Body Weight at Week 68
Tidsramme: Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Tidsramme: Week 68
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Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
Tidsramme: Week 68
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Week 68
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Percentage of Participants Achieving HbA1c < 5.7% at Week 68
Tidsramme: Week 68
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Week 68
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Change from Baseline in Fasting Plasma Glucose at Week 68
Tidsramme: Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
Tidsramme: Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
Tidsramme: Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
Tidsramme: Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
Tidsramme: Baseline to Week 68
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Baseline to Week 68
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Up To 81 Weeks
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Up To 81 Weeks
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Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
Tidsramme: Up To 81 Weeks
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Up To 81 Weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: MD, Amgen
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i det endokrine system
- Ernæringsforstyrrelser
- Metaboliske sygdomme
- Overernæring
- Glukosemetabolismeforstyrrelser
- Diabetes mellitus
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Overvægtig
- Fedme
- Diabetes mellitus, type 2
- Kropsvægt
- Semaglutid
Andre undersøgelses-id-numre
- 20230220
- 2025 (U.S. NIH-bevilling/kontrakt)
- 2025-523772-22-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD-delingstidsramme
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD-delingsadgangskriterier
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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