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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Amgen Call Center
- Numéro de téléphone: 866-572-6436
- E-mail: medinfo@amgen.com
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V5Y 3W2
- Recrutement
- Dr T G Elliott Incorporated - BC Diabetes
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California
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San Diego, California, États-Unis, 92120
- Recrutement
- Acclaim Clinical Research
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Florida
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Miami, Florida, États-Unis, 33155
- Recrutement
- Bioclinical Research Alliance
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Miami Lakes, Florida, États-Unis, 33016
- Recrutement
- Indago Research and Health Center
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Pompano Beach, Florida, États-Unis, 33060
- Recrutement
- Clinical Research Center Of Florida
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Winter Park, Florida, États-Unis, 32789
- Recrutement
- Conquest Research - Winter Park
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Virginia
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Arlington, Virginia, États-Unis, 22205
- Recrutement
- Virginia Nephrology Group
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Washington
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Redmond, Washington, États-Unis, 98052
- Recrutement
- Eastside Research Associates Health Research
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Maridebart cafraglutide
Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. |
Administered subcutaneously.
Autres noms:
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Comparateur actif: Semaglutide
Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. |
Administered subcutaneously. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Délai: Baseline to Week 68
|
Baseline to Week 68
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Plasma Concentration of Maridebart Cafraglutide at Week 68
Délai: Week 68
|
Week 68
|
|
Change from Baseline in HbA1c at week 68 [Superiority]
Délai: Baseline to Week 68
|
Baseline to Week 68
|
|
Percent Change from Baseline in Body Weight at Week 68
Délai: Baseline to Week 68
|
Baseline to Week 68
|
|
Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Délai: Week 68
|
Week 68
|
|
Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
Délai: Week 68
|
Week 68
|
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Percentage of Participants Achieving HbA1c < 5.7% at Week 68
Délai: Week 68
|
Week 68
|
|
Change from Baseline in Fasting Plasma Glucose at Week 68
Délai: Baseline to Week 68
|
Baseline to Week 68
|
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Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
Délai: 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
Délai: 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
Délai: Baseline to Week 68
|
Baseline to Week 68
|
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Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
Délai: Baseline to Week 68
|
Baseline to Week 68
|
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Délai: 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
Délai: Up To 81 Weeks
|
Up To 81 Weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: MD, Amgen
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Troubles nutritionnels
- Maladies métaboliques
- Suralimentation
- Troubles du métabolisme du glucose
- Diabète sucré
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- En surpoids
- Obésité
- Diabète sucré, Type 2
- Poids
- sémaglutide
Autres numéros d'identification d'étude
- 20230220
- 2025 (Subvention/contrat des NIH des États-Unis)
- 2025-523772-22-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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