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).
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Amgen Call Center
- Número de telefone: 866-572-6436
- E-mail: medinfo@amgen.com
Locais de estudo
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Ontario
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Hamilton, Ontario, Canadá, L8L 5G4
- Recrutamento
- Hamilton Medical Research Group
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Arizona
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Gilbert, Arizona, Estados Unidos, 85296
- Recrutamento
- Gilbert Center for Family Medicine
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California
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Canoga Park, California, Estados Unidos, 91304
- Recrutamento
- San Fernando Valley Health Institute
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Cerritos, California, Estados Unidos, 90703
- Recrutamento
- Core Healthcare Group
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La Mesa, California, Estados Unidos, 91942
- Recrutamento
- Velocity Clinical Research Chula Vista
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Modesto, California, Estados Unidos, 95355
- Recrutamento
- Paradigm Clinical Research
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Pomona, California, Estados Unidos, 91767
- Recrutamento
- Empire Clinical Research
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Florida
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Miami, Florida, Estados Unidos, 33135
- Recrutamento
- Optimus U Corporation
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Miami, Florida, Estados Unidos, 33015
- Recrutamento
- San Marcus Research Clinic Inc
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Miami Lakes, Florida, Estados Unidos, 33016
- Recrutamento
- Indago Research and Health Center
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Orlando, Florida, Estados Unidos, 32825
- Recrutamento
- Florida Institute for Clinical Research
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Weston, Florida, Estados Unidos, 33331
- Recrutamento
- Encore Medical Research of Weston LLC
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Winter Park, Florida, Estados Unidos, 32789
- Recrutamento
- Conquest Research - Winter Park
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Illinois
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Skokie, Illinois, Estados Unidos, 60077
- Recrutamento
- Endeavor Health
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Iowa
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West Des Moines, Iowa, Estados Unidos, 50266
- Recrutamento
- Iowa Diabetes Research
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Kansas
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Lenexa, Kansas, Estados Unidos, 66219
- Recrutamento
- JCCT- Juno Northwest Houston
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Newton, Kansas, Estados Unidos, 67114
- Recrutamento
- Alliance for Multispecialty Research Newton
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Wichita, Kansas, Estados Unidos, 67226
- Recrutamento
- Alliance for Multispecialty Research LLC
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Louisiana
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Monroe, Louisiana, Estados Unidos, 71201
- Recrutamento
- Ima Clinical Research- Monroe
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Maryland
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Annapolis, Maryland, Estados Unidos, 21401
- Recrutamento
- Annapolis Internal Medicine, LLC
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Missouri
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Kansas City, Missouri, Estados Unidos, 64114
- Recrutamento
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89148
- Recrutamento
- Palm Research Center Inc
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New Jersey
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Trenton, New Jersey, Estados Unidos, 08611
- Recrutamento
- Premier Research
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North Carolina
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Morehead City, North Carolina, Estados Unidos, 28557
- Recrutamento
- West Clinical Research
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- Recrutamento
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Estados Unidos, 45246
- Recrutamento
- Velocity Clinical Research - Springdale
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Rhode Island
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East Greenwich, Rhode Island, Estados Unidos, 02818
- Recrutamento
- Velocity Clinical Research - Providence
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Texas
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Austin, Texas, Estados Unidos, 78704
- Recrutamento
- Elligo Clinical Research Center
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Bellaire, Texas, Estados Unidos, 77401
- Recrutamento
- Johnson County Clinical Trials Juno Bellaire
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Corpus Christi, Texas, Estados Unidos, 78414
- Recrutamento
- Osvaldo A Brusco MD PA
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Denison, Texas, Estados Unidos, 75020
- Recrutamento
- Soma Clinical Trials, LLC
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Virginia
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Burke, Virginia, Estados Unidos, 22015
- Recrutamento
- Manassas Clinical Research Center Inc
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Ehime
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Matsuyama, Ehime, Japão, 790-0034
- Recrutamento
- Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
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Fukuoka
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Kitakyusyu-shi, Fukuoka, Japão, 807-0072
- Recrutamento
- Morizono Medical Clinic
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Hiroshima
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Aki-gun, Hiroshima, Japão, 735-8585
- Recrutamento
- Mazda Hospital of Mazda Motor Corporation
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Ibaraki
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Mito, Ibaraki, Japão, 310-0826
- Recrutamento
- Nakamoto Medical Clinic
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Naka, Ibaraki, Japão, 311-0113
- Recrutamento
- Nakakinen Clinic
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Tsuchiura-shi, Ibaraki, Japão, 300-0835
- Recrutamento
- Ohishi Naika Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japão, 860-0863
- Recrutamento
- Morinaga Ueno Clinic
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Osaka
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Kashiwara-shi, Osaka, Japão, 582-0005
- Recrutamento
- Shiraiwa Medical Clinic
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Shizuoka
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Shizuoka, Shizuoka, Japão, 424-0855
- Recrutamento
- Suruga Clinic
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Tokyo
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Meguro-ku, Tokyo, Japão, 153-0053
- Recrutamento
- Yutenji Medical Clinic
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Mitaka-shi, Tokyo, Japão, 181-0013
- Recrutamento
- Medical Corporation Ouitsukai Kanno Naika
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San Juan, Porto Rico, 00909
- Recrutamento
- Latin Clinical Trial Center
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Birmingham, Reino Unido, B21 9RY
- Recrutamento
- FutureMeds Birmingham
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
Outros nomes:
|
|
Experimental: 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.
Outros nomes:
|
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Experimental: 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.
Outros nomes:
|
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Comparador de Placebo: 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. |
|
Experimental: 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.
Outros nomes:
|
|
Experimental: 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.
Outros nomes:
|
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Comparador de Placebo: 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. |
|
Experimental: 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.
Outros nomes:
|
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Experimental: 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Change from Baseline of the Parent Trial in Waist Circumference
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Week 48 of current trial
|
Week 48 of current trial
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: MD, Amgen
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Distúrbios Nutricionais
- Doenças Metabólicas
- Supernutrição
- Peso corporal
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Diabetes Mellitus, Tipo 2
Outros números de identificação do estudo
- 20210182
- 2025-524788-19-00 (Ctis)
- U1111-1332-0531 (Outro identificador: WHO/UTN Number)
- 2025 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Prazo de Compartilhamento de IPD
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.
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .