Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
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).
Studieoversikt
Status
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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Ontario
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Hamilton, Ontario, Canada, L8L 5G4
- Rekruttering
- Hamilton Medical Research Group
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Arizona
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Gilbert, Arizona, Forente stater, 85296
- Rekruttering
- Gilbert Center for Family Medicine
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California
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Canoga Park, California, Forente stater, 91304
- Rekruttering
- San Fernando Valley Health Institute
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Cerritos, California, Forente stater, 90703
- Rekruttering
- Core Healthcare Group
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La Mesa, California, Forente stater, 91942
- Rekruttering
- Velocity Clinical Research Chula Vista
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Modesto, California, Forente stater, 95355
- Rekruttering
- Paradigm Clinical Research
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Pomona, California, Forente stater, 91767
- Rekruttering
- Empire Clinical Research
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Florida
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Miami, Florida, Forente stater, 33135
- Rekruttering
- Optimus U Corporation
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Miami, Florida, Forente stater, 33015
- Rekruttering
- San Marcus Research Clinic Inc
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Miami Lakes, Florida, Forente stater, 33016
- Rekruttering
- Indago Research and Health Center
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Orlando, Florida, Forente stater, 32825
- Rekruttering
- Florida Institute for Clinical Research
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Weston, Florida, Forente stater, 33331
- Rekruttering
- Encore Medical Research of Weston LLC
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Winter Park, Florida, Forente stater, 32789
- Rekruttering
- Conquest Research - Winter Park
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Illinois
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Skokie, Illinois, Forente stater, 60077
- Rekruttering
- Endeavor Health
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Iowa
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West Des Moines, Iowa, Forente stater, 50266
- Rekruttering
- Iowa Diabetes Research
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Kansas
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Lenexa, Kansas, Forente stater, 66219
- Rekruttering
- JCCT- Juno Northwest Houston
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Newton, Kansas, Forente stater, 67114
- Rekruttering
- Alliance for Multispecialty Research Newton
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Wichita, Kansas, Forente stater, 67226
- Rekruttering
- Alliance for Multispecialty Research LLC
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Louisiana
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Monroe, Louisiana, Forente stater, 71201
- Rekruttering
- Ima Clinical Research- Monroe
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Maryland
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Annapolis, Maryland, Forente stater, 21401
- Rekruttering
- Annapolis Internal Medicine, LLC
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Missouri
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Kansas City, Missouri, Forente stater, 64114
- Rekruttering
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, Forente stater, 89148
- Rekruttering
- Palm Research Center Inc
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New Jersey
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Trenton, New Jersey, Forente stater, 08611
- Rekruttering
- Premier Research
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North Carolina
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Morehead City, North Carolina, Forente stater, 28557
- Rekruttering
- West Clinical Research
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Ohio
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Cincinnati, Ohio, Forente stater, 45242
- Rekruttering
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Forente stater, 45246
- Rekruttering
- Velocity Clinical Research - Springdale
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Rhode Island
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East Greenwich, Rhode Island, Forente stater, 02818
- Rekruttering
- Velocity Clinical Research - Providence
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Texas
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Austin, Texas, Forente stater, 78704
- Rekruttering
- Elligo Clinical Research Center
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Bellaire, Texas, Forente stater, 77401
- Rekruttering
- Johnson County Clinical Trials Juno Bellaire
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Corpus Christi, Texas, Forente stater, 78414
- Rekruttering
- Osvaldo A Brusco MD PA
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Denison, Texas, Forente stater, 75020
- Rekruttering
- Soma Clinical Trials, LLC
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Virginia
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Burke, Virginia, Forente stater, 22015
- Rekruttering
- Manassas Clinical Research Center Inc
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Ehime
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Matsuyama, Ehime, Japan, 790-0034
- Rekruttering
- Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
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Fukuoka
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Kitakyusyu-shi, Fukuoka, Japan, 807-0072
- Rekruttering
- Morizono Medical Clinic
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Hiroshima
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Aki-gun, Hiroshima, Japan, 735-8585
- Rekruttering
- Mazda Hospital of Mazda Motor Corporation
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Ibaraki
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Mito, Ibaraki, Japan, 310-0826
- Rekruttering
- Nakamoto Medical Clinic
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Naka, Ibaraki, Japan, 311-0113
- Rekruttering
- Nakakinen Clinic
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Tsuchiura-shi, Ibaraki, Japan, 300-0835
- Rekruttering
- Ohishi Naika Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japan, 860-0863
- Rekruttering
- Morinaga Ueno Clinic
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Osaka
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Kashiwara-shi, Osaka, Japan, 582-0005
- Rekruttering
- Shiraiwa Medical Clinic
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Shizuoka
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Shizuoka, Shizuoka, Japan, 424-0855
- Rekruttering
- Suruga Clinic
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Tokyo
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Meguro-ku, Tokyo, Japan, 153-0053
- Rekruttering
- Yutenji Medical Clinic
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Mitaka-shi, Tokyo, Japan, 181-0013
- Rekruttering
- Medical Corporation Ouitsukai Kanno Naika
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San Juan, Puerto Rico, 00909
- Rekruttering
- Latin Clinical Trial Center
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Birmingham, Storbritannia, B21 9RY
- Rekruttering
- FutureMeds Birmingham
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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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Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
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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.
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Participants must use protocol-specified contraception during treatment and for 16 weeks after the last dose of trial intervention.
Exclusion Criteria:
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Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity.
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Body mass index (BMI) ≤ 18.5 kilograms per meter square (kg/m^2).
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Participant has known sensitivity to any of the products or components to be administered during dosing.
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History of ischemic optic neuropathy.
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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
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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).
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Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization.
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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.
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Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
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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.
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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.
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Major surgical procedures planned during the trial.
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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.
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Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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). |
Administered subcutaneously.
Andre navn:
|
|
Eksperimentell: 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. |
Administered subcutaneously.
Andre navn:
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Eksperimentell: 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). |
Administered subcutaneously.
Andre navn:
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Placebo komparator: 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. |
Administered subcutaneously. |
|
Eksperimentell: 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. |
Administered subcutaneously.
Andre navn:
|
|
Eksperimentell: 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. |
Administered subcutaneously.
Andre navn:
|
|
Placebo komparator: 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. |
Administered subcutaneously. |
|
Eksperimentell: 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. |
Administered subcutaneously.
Andre navn:
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Eksperimentell: 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. |
Administered subcutaneously.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from Baseline of the Parent Trial in Waist Circumference
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
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Change from Baseline in HbA1c
Tidsramme: Week 48 of current trial
|
Week 48 of current trial
|
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
- 20210182
- 2025-524788-19-00 (Ctis)
- U1111-1332-0531 (Annen identifikator: WHO/UTN Number)
- 2025 (U.S. NIH-stipend/kontrakt)
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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