Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight (MARITIME-PEN)
A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus
The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.
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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San Juan, Porto Rico, 00909
- Recrutement
- Latin Clinical Trial Center
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California
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San Diego, California, États-Unis, 92120
- Recrutement
- Apex Clinical Research
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Florida
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Miami, Florida, États-Unis, 33173
- Recrutement
- Research Institute of South Florida
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Miami, Florida, États-Unis, 33125
- Recrutement
- Southern Clinical Research
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Orlando, Florida, États-Unis, 32825
- Recrutement
- Florida Institute for Clinical Research
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Orlando, Florida, États-Unis, 32801
- Recrutement
- Clinical Neuroscience Solutions LLC
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The Villages, Florida, États-Unis, 32162
- Recrutement
- Charter Research - The Villages
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Georgia
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Johns Creek, Georgia, États-Unis, 30024
- Recrutement
- Nsc Research
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Woodstock, Georgia, États-Unis, 30189
- Recrutement
- North Georgia Clinical Research
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Idaho
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Meridian, Idaho, États-Unis, 83646
- Recrutement
- Solaris Clinical Research
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Illinois
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Oak Brook, Illinois, États-Unis, 60523
- Recrutement
- Alliance For Multispecialty Research - Oak Brook
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Maryland
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Bowie, Maryland, États-Unis, 20715
- Recrutement
- Flourish Research
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New York
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Rochester, New York, États-Unis, 14609
- Recrutement
- Rochester Clinical Research
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North Carolina
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Morehead City, North Carolina, États-Unis, 28557
- Recrutement
- Centricity Research
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Ohio
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Columbus, Ohio, États-Unis, 43213
- Recrutement
- Centricity Research Dublin
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Oklahoma
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Chickasha, Oklahoma, États-Unis, 73018
- Recrutement
- Epic Medical Research - Oklahoma
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South Carolina
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Greenville, South Carolina, États-Unis, 29607
- Recrutement
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Texas
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Dallas, Texas, États-Unis, 75251
- Recrutement
- Cedar Health Research, LLC
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Dallas, Texas, États-Unis, 75235
- Recrutement
- Cedar Health Research- Texas Native Health
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DeSoto, Texas, États-Unis, 75115
- Recrutement
- Epic Medical Research - Red Oak
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Denison, Texas, États-Unis, 75020
- Recrutement
- Soma Clinical Trials, LLC
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Houston, Texas, États-Unis, 77043
- Recrutement
- Biopharma Informatic, LLC
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Houston, Texas, États-Unis, 77089
- Recrutement
- Research Physicians Network LLC
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McKinney, Texas, États-Unis, 75071
- Recrutement
- Texas Institute of Cardiology
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North Richland Hills, Texas, États-Unis, 76180
- Recrutement
- North Hills Medical 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:
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Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m^2), or BMI ≥ 27 to < 30 kg/m^2 with one of the following:
- hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg
- dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.
- history of obstructive sleep apnea
- history of cardiovascular disease
- history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease [MASLD] or metabolic dysfunction-associated steatohepatitis [MASH])
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At least 1 unsuccessful attempt at weight loss by diet and exercise.
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Contraception for females.
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Willingness to follow trial procedures for the duration of the trial.
Exclusion Criteria:
- Obesity induced by other endocrinologic disorders.
- Change in body weight > 5 kg within last 90 days.
- Previous or planned surgical, endoscopic, or device-based treatment for obesity.
- History of malignancy within the past 5 years.
- Type 1 or Type 2 diabetes mellitus.
- History of chronic pancreatitis or history of acute pancreatitis within last 180 days.
- Family or personal history of medullary thyroid cancer.
- Previous participation in a Maridebart Cafraglutide trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Maridebart cafraglutide
Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide. |
Administered subcutaneously.
Autres noms:
The AI will be used by participants to self-administer SC doses of maridebart cafraglutide. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration
Délai: Weeks 12, 16, and 20
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Weeks 12, 16, and 20
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Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration
Délai: Weeks 12, 16, and 20
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Weeks 12, 16, and 20
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Variation en pourcentage du poids corporel par rapport au départ à la semaine 24
Délai: Ligne de base et semaine 24
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Ligne de base et semaine 24
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Number of Participants Who Experience Device-related Adverse Events
Délai: Up To 37 weeks
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Up To 37 weeks
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Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Délai: TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).
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TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).
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Plasma Concentration of Maridebart Cafraglutide at Week 24
Délai: Week 24
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Week 24
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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
Autres numéros d'identification d'étude
- 20250207
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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