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.
Studieöversikt
Status
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
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California
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San Diego, California, Förenta staterna, 92120
- Rekrytering
- Apex Clinical Research
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Florida
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Miami, Florida, Förenta staterna, 33173
- Rekrytering
- Research Institute of South Florida
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Miami, Florida, Förenta staterna, 33125
- Rekrytering
- Southern Clinical Research
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Orlando, Florida, Förenta staterna, 32825
- Rekrytering
- Florida Institute for Clinical Research
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Orlando, Florida, Förenta staterna, 32801
- Rekrytering
- Clinical Neuroscience Solutions LLC
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The Villages, Florida, Förenta staterna, 32162
- Rekrytering
- Charter Research - The Villages
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Georgia
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Johns Creek, Georgia, Förenta staterna, 30024
- Rekrytering
- Nsc Research
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Woodstock, Georgia, Förenta staterna, 30189
- Rekrytering
- North Georgia Clinical Research
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Idaho
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Meridian, Idaho, Förenta staterna, 83646
- Rekrytering
- Solaris Clinical Research
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Illinois
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Oak Brook, Illinois, Förenta staterna, 60523
- Rekrytering
- Alliance For Multispecialty Research - Oak Brook
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Maryland
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Bowie, Maryland, Förenta staterna, 20715
- Rekrytering
- Flourish Research
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New York
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Rochester, New York, Förenta staterna, 14609
- Rekrytering
- Rochester Clinical Research
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North Carolina
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Morehead City, North Carolina, Förenta staterna, 28557
- Rekrytering
- Centricity Research
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Ohio
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Columbus, Ohio, Förenta staterna, 43213
- Rekrytering
- Centricity Research Dublin
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Oklahoma
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Chickasha, Oklahoma, Förenta staterna, 73018
- Rekrytering
- Epic Medical Research - Oklahoma
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29607
- Rekrytering
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Texas
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Dallas, Texas, Förenta staterna, 75251
- Rekrytering
- Cedar Health Research, LLC
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Dallas, Texas, Förenta staterna, 75235
- Rekrytering
- Cedar Health Research- Texas Native Health
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DeSoto, Texas, Förenta staterna, 75115
- Rekrytering
- Epic Medical Research - Red Oak
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Denison, Texas, Förenta staterna, 75020
- Rekrytering
- Soma Clinical Trials, LLC
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Houston, Texas, Förenta staterna, 77043
- Rekrytering
- Biopharma Informatic, LLC
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Houston, Texas, Förenta staterna, 77089
- Rekrytering
- Research Physicians Network LLC
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McKinney, Texas, Förenta staterna, 75071
- Rekrytering
- Texas Institute of Cardiology
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North Richland Hills, Texas, Förenta staterna, 76180
- Rekrytering
- North Hills Medical Research
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San Juan, Puerto Rico, 00909
- Rekrytering
- Latin Clinical Trial Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Maridebart cafraglutide
Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide. |
Administered subcutaneously.
Andra namn:
The AI will be used by participants to self-administer SC doses of maridebart cafraglutide. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration
Tidsram: Weeks 12, 16, and 20
|
Weeks 12, 16, and 20
|
|
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
Tidsram: Weeks 12, 16, and 20
|
Weeks 12, 16, and 20
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Procentuell förändring från baslinjen i kroppsvikt vid vecka 24
Tidsram: Baslinje och vecka 24
|
Baslinje och vecka 24
|
|
Number of Participants Who Experience Device-related Adverse Events
Tidsram: Up To 37 weeks
|
Up To 37 weeks
|
|
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsram: 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).
|
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).
|
|
Plasma Concentration of Maridebart Cafraglutide at Week 24
Tidsram: Week 24
|
Week 24
|
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
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20250207
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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