Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
2 september 2026 bijgewerkt door: Amgen
A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus
The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus.
Trial 20210182 is extension of trial 20210184 (NCT06858878).
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
950
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Amgen Call Center
- Telefoonnummer: 866-572-6436
- E-mail: medinfo@amgen.com
Studie Locaties
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Ehime
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Matsuyama, Ehime, Japan, 790-0034
- Werving
- Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
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Fukuoka
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Kitakyusyu-shi, Fukuoka, Japan, 807-0072
- Werving
- Morizono medical clinic
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Ibaraki
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Mito, Ibaraki, Japan, 310-0826
- Werving
- Nakamoto Medical Clinic
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Naka, Ibaraki, Japan, 311-0113
- Werving
- Nakakinen clinic
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Tsuchiura-shi, Ibaraki, Japan, 300-0835
- Werving
- Ohishi Naika Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japan, 860-0863
- Werving
- Morinaga Ueno Clinic
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Osaka
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Kashiwara-shi, Osaka, Japan, 582-0005
- Werving
- Shiraiwa Medical Clinic
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Shizuoka
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Shizuoka, Shizuoka, Japan, 424-0855
- Werving
- Suruga Clinic
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Tokyo
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Mitaka-shi, Tokyo, Japan, 181-0013
- Werving
- Medical Corporation Ouitsukai Kanno Naika
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San Juan, Puerto Rico, 00909
- Werving
- Latin Clinical Trial Center
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Arizona
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Gilbert, Arizona, Verenigde Staten, 85296
- Werving
- Gilbert Center For Family Medicine
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California
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Canoga Park, California, Verenigde Staten, 91304
- Werving
- San Fernando Valley Health Institute
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Cerritos, California, Verenigde Staten, 90703
- Werving
- Core Healthcare Group
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Chula Vista, California, Verenigde Staten, 91911
- Werving
- Velocity Clinical Research Chula Vista
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Pomona, California, Verenigde Staten, 91767
- Werving
- Empire Clinical Research
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Florida
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Miami, Florida, Verenigde Staten, 33135
- Werving
- Optimus U Corporation
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Miami Lakes, Florida, Verenigde Staten, 33014
- Werving
- San Marcus Research Clinic Inc
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Miami Lakes, Florida, Verenigde Staten, 33016
- Werving
- Indago Research and Health Center
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Orlando, Florida, Verenigde Staten, 32825
- Werving
- Florida Institute for Clinical Research
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Weston, Florida, Verenigde Staten, 33331
- Werving
- Encore Medical Research of Weston LLC
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Winter Park, Florida, Verenigde Staten, 32789
- Werving
- Conquest Research - Winter Park
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Iowa
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West Des Moines, Iowa, Verenigde Staten, 50266
- Werving
- Iowa Diabetes Research
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Kansas
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Newton, Kansas, Verenigde Staten, 67114
- Werving
- Alliance for Multispecialty Research Newton
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Wichita, Kansas, Verenigde Staten, 67226
- Werving
- Alliance for Multispecialty Research LLC
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64114
- Werving
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89128
- Werving
- Palm Research Center Inc
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New Jersey
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Trenton, New Jersey, Verenigde Staten, 08611
- Werving
- Premier Research
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North Carolina
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Morehead City, North Carolina, Verenigde Staten, 28557
- Werving
- West Clinical Research
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45242
- Werving
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Verenigde Staten, 45246
- Werving
- Velocity Clinical Research - Springdale
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Rhode Island
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East Greenwich, Rhode Island, Verenigde Staten, 02818
- Werving
- Velocity Clinical Research - Providence
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Texas
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Austin, Texas, Verenigde Staten, 78704
- Werving
- Elligo Clinical Research Center
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Bellaire, Texas, Verenigde Staten, 77401
- Werving
- Johnson County Clinical Trials Juno Bellaire
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Corpus Christi, Texas, Verenigde Staten, 78414
- Werving
- Osvaldo A Brusco MD PA
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Denison, Texas, Verenigde Staten, 75020
- Werving
- Soma Clinical Trials, LLC
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Houston, Texas, Verenigde Staten, 77040
- Werving
- JCCT- Juno Northwest Houston
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Virginia
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Manassas, Virginia, Verenigde Staten, 20110
- Werving
- Manassas Clinical Research Center Inc
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
Participants completing Study 20210184 must meet the following criteria:
- Completed the Week 72 visit in Study 20210184.
- Did not permanently discontinue the investigational product in the parent trial (20210184).
- Randomized within 7 days of week 72 visit in the parent trial.
- Participants must use protocol-specified contraception during treatment and for 16 weeks after the last dose of trial intervention.
Exclusion Criteria:
- Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity.
- Body mass index (BMI) ≤ 18.5 kilograms per meter square (kg/m^2).
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- History of ischemic optic neuropathy.
Any malignancy diagnosed during the parent trial, except for the following treated with curative intent:
- Nonmelanoma skin cancers
- Breast ductal carcinoma in situ
- Cervical carcinoma in situ
- Prostate cancer in situ
- Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative[s]) history of medullary thyroid carcinoma (MTC).
- Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization.
- Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the parent trial before randomization.
- Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
- History or evidence of any other clinically significant disorder, condition, disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety.
- Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention.
- Major surgical procedures planned during the trial.
- Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator.
- Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Maridebart Cafraglutide Medium Dose Q4W
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.
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Administered subcutaneously.
Andere namen:
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Placebo-vergelijker: Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
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Subcutaan toegediend.
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Experimenteel: Maridebart Cafraglutide High Dose Q4W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.
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Administered subcutaneously.
Andere namen:
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Experimenteel: Maridebart Cafraglutide High Dose Q8W
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.
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Administered subcutaneously.
Andere namen:
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Placebo-vergelijker: Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
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Subcutaan toegediend.
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Experimenteel: Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)
Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W.
Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.
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Administered subcutaneously.
Andere namen:
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Experimenteel: Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)
Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.
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Administered subcutaneously.
Andere namen:
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Experimenteel: Maridebart Cafraglutide Low Dose Q4W
Participants who received low dose of maridebart cafraglutide in the parent trial (20210184 [NCT06858878]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks (Q4W).
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Administered subcutaneously.
Andere namen:
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Experimenteel: Maridebart Cafraglutide Medium dose Q8W
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8 weeks (Q8W).
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Administered subcutaneously.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tijdsspanne: Baseline of current trial up to 60 weeks
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Baseline of current trial up to 60 weeks
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Percent Change in Body Weight from Baseline of the Parent Trial (20210184)
Tijdsspanne: Baseline of parent trial (20210184) to Week 48 of current trial
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Baseline of parent trial (20210184) to Week 48 of current trial
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change from Baseline of the Parent Trial in Waist Circumference
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percent Change from Baseline in Body Weight
Tijdsspanne: Baseline of current trial to Week 48
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Baseline of current trial to Week 48
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Percentage of Participants with No Body Weight Gain of >3% From Baseline
Tijdsspanne: Week 48 of current trial
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Week 48 of current trial
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Percentage of Participants with No Body Weight Gain of >5% From Baseline
Tijdsspanne: Week 48 of current trial
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Week 48 of current trial
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Percentage of Body Weight Reduction Maintained from the Parent Trial
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Change from Baseline of the Parent Trial in Hemoglobin A1c
Tijdsspanne: Baseline of parent trial to Week 48 of current trial
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Baseline of parent trial to Week 48 of current trial
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Change from Baseline in HbA1c
Tijdsspanne: Week 48 of current trial
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Week 48 of current trial
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: MD, Amgen
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
29 juli 2026
Primaire voltooiing (Geschat)
26 december 2027
Studie voltooiing (Geschat)
19 maart 2028
Studieregistratiedata
Eerst ingediend
29 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 juni 2026
Eerst geplaatst (Werkelijk)
6 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 september 2026
Laatste update ingediend die voldeed aan QC-criteria
2 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20210182
- 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524788-19-00 (Ctis)
- U1111-1332-0531 (Andere identificatie: WHO/UTN Number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD-tijdsbestek voor delen
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-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .