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.
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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California
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San Diego, California, Forenede Stater, 92120
- Rekruttering
- Apex Clinical Research
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Florida
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Miami, Florida, Forenede Stater, 33173
- Rekruttering
- Research Institute of South Florida
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Miami, Florida, Forenede Stater, 33125
- Rekruttering
- Southern Clinical Research
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Orlando, Florida, Forenede Stater, 32825
- Rekruttering
- Florida Institute for Clinical Research
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Orlando, Florida, Forenede Stater, 32801
- Rekruttering
- Clinical Neuroscience Solutions LLC
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The Villages, Florida, Forenede Stater, 32162
- Rekruttering
- Charter Research - The Villages
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Georgia
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Johns Creek, Georgia, Forenede Stater, 30024
- Rekruttering
- Nsc Research
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Woodstock, Georgia, Forenede Stater, 30189
- Rekruttering
- North Georgia Clinical Research
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Idaho
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Meridian, Idaho, Forenede Stater, 83646
- Rekruttering
- Solaris Clinical Research
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Illinois
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Oak Brook, Illinois, Forenede Stater, 60523
- Rekruttering
- Alliance For Multispecialty Research - Oak Brook
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Maryland
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Bowie, Maryland, Forenede Stater, 20715
- Rekruttering
- Flourish Research
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New York
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Rochester, New York, Forenede Stater, 14609
- Rekruttering
- Rochester Clinical Research
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North Carolina
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Morehead City, North Carolina, Forenede Stater, 28557
- Rekruttering
- Centricity Research
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Ohio
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Columbus, Ohio, Forenede Stater, 43213
- Rekruttering
- Centricity Research Dublin
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Oklahoma
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Chickasha, Oklahoma, Forenede Stater, 73018
- Rekruttering
- Epic Medical Research - Oklahoma
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Rekruttering
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Texas
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Dallas, Texas, Forenede Stater, 75251
- Rekruttering
- Cedar Health Research, LLC
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Dallas, Texas, Forenede Stater, 75235
- Rekruttering
- Cedar Health Research- Texas Native Health
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DeSoto, Texas, Forenede Stater, 75115
- Rekruttering
- Epic Medical Research - Red Oak
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Denison, Texas, Forenede Stater, 75020
- Rekruttering
- Soma Clinical Trials, LLC
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Houston, Texas, Forenede Stater, 77043
- Rekruttering
- Biopharma Informatic, LLC
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Houston, Texas, Forenede Stater, 77089
- Rekruttering
- Research Physicians Network LLC
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McKinney, Texas, Forenede Stater, 75071
- Rekruttering
- Texas Institute of Cardiology
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North Richland Hills, Texas, Forenede Stater, 76180
- Rekruttering
- North Hills Medical Research
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San Juan, Puerto Rico, 00909
- Rekruttering
- Latin Clinical Trial Center
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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:
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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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Maridebart cafraglutide
Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide. |
Administered subcutaneously.
Andre navne:
The AI will be used by participants to self-administer SC doses of maridebart cafraglutide. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration
Tidsramme: Weeks 12, 16, and 20
|
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
Tidsramme: Weeks 12, 16, and 20
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Weeks 12, 16, and 20
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Procentvis ændring fra baseline i kropsvægt i uge 24
Tidsramme: Baseline og uge 24
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Baseline og uge 24
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Number of Participants Who Experience Device-related Adverse Events
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Week 24
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Week 24
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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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20250207
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
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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