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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-post: medinfo@amgen.com
Studieorter
-
-
California
-
San Diego, California, Förenta staterna, 92120
- Rekrytering
- Acclaim Clinical Research
-
-
Florida
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Miami, Florida, Förenta staterna, 33155
- Rekrytering
- Bioclinical Research Alliance
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Miami Lakes, Florida, Förenta staterna, 33016
- Rekrytering
- Indago Research and Health Center
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Pompano Beach, Florida, Förenta staterna, 33060
- Rekrytering
- Clinical Research Center Of Florida
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Winter Park, Florida, Förenta staterna, 32789
- Rekrytering
- Conquest Research - Winter Park
-
-
Virginia
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Arlington, Virginia, Förenta staterna, 22205
- Rekrytering
- Virginia Nephrology Group
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-
Washington
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Redmond, Washington, Förenta staterna, 98052
- Rekrytering
- Eastside Research Associates Health Research
-
-
-
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British Columbia
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Vancouver, British Columbia, Kanada, V5Y 3W2
- Rekrytering
- Dr T G Elliott Incorporated - BC Diabetes
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Maridebart cafraglutide
Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. |
Administered subcutaneously.
Andra namn:
|
|
Aktiv komparator: Semaglutide
Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. |
Administered subcutaneously. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Tidsram: Baseline to Week 68
|
Baseline to Week 68
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Plasma Concentration of Maridebart Cafraglutide at Week 68
Tidsram: Week 68
|
Week 68
|
|
Change from Baseline in HbA1c at week 68 [Superiority]
Tidsram: Baseline to Week 68
|
Baseline to Week 68
|
|
Percent Change from Baseline in Body Weight at Week 68
Tidsram: Baseline to Week 68
|
Baseline to Week 68
|
|
Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Tidsram: Week 68
|
Week 68
|
|
Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
Tidsram: Week 68
|
Week 68
|
|
Percentage of Participants Achieving HbA1c < 5.7% at Week 68
Tidsram: Week 68
|
Week 68
|
|
Change from Baseline in Fasting Plasma Glucose at Week 68
Tidsram: Baseline to Week 68
|
Baseline to Week 68
|
|
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
Tidsram: Baseline to Week 68
|
Baseline to Week 68
|
|
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
Tidsram: Baseline to Week 68
|
Baseline to Week 68
|
|
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
Tidsram: Baseline to Week 68
|
Baseline to Week 68
|
|
Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
Tidsram: Baseline to Week 68
|
Baseline to Week 68
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsram: Up To 81 Weeks
|
Up To 81 Weeks
|
|
Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
Tidsram: Up To 81 Weeks
|
Up To 81 Weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: MD, Amgen
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20230220
- 2025 (U.S.S. NIH-anslag/kontrakt)
- 2025-523772-22-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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