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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-post: medinfo@amgen.com
Studiesteder
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California
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San Diego, California, Forente stater, 92120
- Rekruttering
- Apex Clinical Research
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Florida
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Miami, Florida, Forente stater, 33173
- Rekruttering
- Research Institute of South Florida
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Miami, Florida, Forente stater, 33125
- Rekruttering
- Southern Clinical Research
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Orlando, Florida, Forente stater, 32825
- Rekruttering
- Florida Institute for Clinical Research
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Orlando, Florida, Forente stater, 32801
- Rekruttering
- Clinical Neuroscience Solutions LLC
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The Villages, Florida, Forente stater, 32162
- Rekruttering
- Charter Research - The Villages
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Georgia
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Johns Creek, Georgia, Forente stater, 30024
- Rekruttering
- Nsc Research
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Woodstock, Georgia, Forente stater, 30189
- Rekruttering
- North Georgia Clinical Research
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Idaho
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Meridian, Idaho, Forente stater, 83646
- Rekruttering
- Solaris Clinical Research
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Illinois
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Oak Brook, Illinois, Forente stater, 60523
- Rekruttering
- Alliance For Multispecialty Research - Oak Brook
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Maryland
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Bowie, Maryland, Forente stater, 20715
- Rekruttering
- Flourish Research
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New York
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Rochester, New York, Forente stater, 14609
- Rekruttering
- Rochester Clinical Research
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North Carolina
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Morehead City, North Carolina, Forente stater, 28557
- Rekruttering
- Centricity Research
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Ohio
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Columbus, Ohio, Forente stater, 43213
- Rekruttering
- Centricity Research Dublin
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Oklahoma
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Chickasha, Oklahoma, Forente stater, 73018
- Rekruttering
- Epic Medical Research - Oklahoma
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South Carolina
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Greenville, South Carolina, Forente stater, 29607
- Rekruttering
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Texas
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Dallas, Texas, Forente stater, 75251
- Rekruttering
- Cedar Health Research, LLC
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Dallas, Texas, Forente stater, 75235
- Rekruttering
- Cedar Health Research- Texas Native Health
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DeSoto, Texas, Forente stater, 75115
- Rekruttering
- Epic Medical Research - Red Oak
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Denison, Texas, Forente stater, 75020
- Rekruttering
- Soma Clinical Trials, LLC
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Houston, Texas, Forente stater, 77043
- Rekruttering
- Biopharma Informatic, LLC
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Houston, Texas, Forente stater, 77089
- Rekruttering
- Research Physicians Network LLC
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McKinney, Texas, Forente stater, 75071
- Rekruttering
- Texas Institute of Cardiology
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North Richland Hills, Texas, Forente 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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Maridebart cafraglutide
Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide. |
Administered subcutaneously.
Andre navn:
The AI will be used by participants to self-administer SC doses of maridebart cafraglutide. |
Hva måler studien?
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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Prosentvis endring fra baseline i kroppsvekt ved uke 24
Tidsramme: Utgangspunkt og uke 24
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Utgangspunkt og uke 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: MD, Amgen
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20250207
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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