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NCT07684235ClinicalTrials.gov

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-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

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En resumen

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Fase 33200 participantes buscados87 centros4 países

Categorías

Endocrino y metabólico100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2026-07-06; recorded start 2026-07-23
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 303 other studies in this databaseCounted from the lead sponsor named in the record (Amgen)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding13/20

    Double-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 31 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 3,200 participants (target), run at 87 sites, across 4 countries.

How this score is built
  • Enrolment34/40

    3,200 participants (target)

  • Site count18/25

    31 sites

  • Country count7/15

    2 countries

  • Planned duration6/10

    Planned over about 20 months

  • Sponsor scale9/10

    Amgen has led 301 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Afecciones

  • Obesity
  • Overweight

Elegibilidad

SexoTodos
Edades18 Years – 99 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Completed the parent trial (2010181) * Completed week 72 visit in parent trial * Did not permanently discontinue trial intervention in parent trial * Randomized within 7 Days of week 72 visit in the parent trial * Participants must use protocol-specified contraception during treatment, and for an additional 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 ≤ 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 parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ. * Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer. * Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization * Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from 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, or 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).

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoDOUBLE (2)
Inscripción3200 participantes buscados

Patrocinador y colaboradores

  • Amgen Patrocinador

Grupos e intervenciones

  • Maridebart Cafraglutide Low Dose Q4WEXPERIMENTAL

    Participants who received low dose of maridebart cafraglutide in the parent trial (20210181 \[NCT06858839\]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks(Q4W).

  • Maridebart Cafraglutide Medium Dose Q4WEXPERIMENTAL

    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.

  • Maridebart Cafraglutide Medium Dose Q8WEXPERIMENTAL

    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 8weeks (Q8W).

  • Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)PLACEBO_COMPARATOR

    Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.

  • Maridebart Cafraglutide High Dose Q4WEXPERIMENTAL

    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.

  • Maridebart Cafraglutide High Dose Q8WEXPERIMENTAL

    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.

  • Maridebart Cafraglutide High Dose Q12WEXPERIMENTAL

    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 once in 12 weeks (Q12W).

  • Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)PLACEBO_COMPARATOR

    Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.

  • Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)EXPERIMENTAL

    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.

  • Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)EXPERIMENTAL

    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.

Intervenciones

  • Fármaco Maridebart cafraglutide

    Administered subcutaneously

  • Fármaco Placebo

    Administered subcutaneously.

Variables de resultado

  1. Variable de resultado principal

    Percent Change in Body Weight from Baseline of the Parent Trial (20210181)

    Plazo Baseline of parent trial (20210181) to Week 48 of current trial

  2. Variable de resultado principal

    Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Plazo Baseline of current trial up to 60 weeks

  3. Variable de resultado secundaria

    Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial

    Plazo Baseline of parent trial to Week 48 of current trial

  4. Variable de resultado secundaria

    Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline of the Parent Trial

    Plazo Baseline of parent trial to Week 48 of current trial

  5. Variable de resultado secundaria

    Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline of the Parent Trial

    Plazo Baseline of parent trial to Week 48 of current trial

  6. Variable de resultado secundaria

    Percentage of Participants Achieving ≥20% Reduction in Body Weight from Baseline of the Parent Trial

    Plazo Baseline of parent trial to Week 48 of current trial

  7. Variable de resultado secundaria

    Change from Baseline of the Parent Trial in Waist Circumference

    Plazo Baseline of parent trial to Week 48 of current trial

  8. Variable de resultado secundaria

    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

    Plazo Baseline of parent trial to Week 48 of current trial

  9. Variable de resultado secundaria

    Percent Change from Baseline in Body Weight

    Plazo Baseline of current trial to Week 48

  10. Variable de resultado secundaria

    Percentage of Participants with No Body Weight Gain of >3% From Baseline

    Plazo Week 48 of current trial

  11. Variable de resultado secundaria

    Percentage of Participants with No Body Weight Gain of >5% From Baseline

    Plazo Week 48 of current trial

  12. Variable de resultado secundaria

    Percentage of Body Weight Reduction Maintained from the Parent Trial

    Plazo Baseline of parent trial to Week 48 of current trial

  13. Variable de resultado secundaria

    Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial

    Plazo Baseline of parent trial to Week 48 of current trial

Fechas

Fecha de inicio23 de julio de 2026 (real)
Finalización principal26 de diciembre de 2027 (estimada)
Finalización19 de marzo de 2028 (estimada)
Primera publicación6 de julio de 2026 (real)
Última actualización3 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

87 centros están en reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Emeritus Research SydneyBotanyNew South WalesEn reclutamiento
Emeritus Research CamberwellCamberwellVictoriaEn reclutamiento
NovatrialsCharlestownNew South WalesEn reclutamiento
Canopy Clinical SutherlandMirandaNew South WalesEn reclutamiento
Canopy Clinical Altona NorthNorth AltonaVictoriaEn reclutamiento
Fusion Clinical ResearchNorwoodSouth AustraliaEn reclutamiento
Canopy Clinical WollongongWollongongNew South WalesEn reclutamiento

Japan

CentroCiudadEstado o regiónEstado
Doujin Memorial Foundation, Meiwa HospitalChiyoda-kuTokyoEn reclutamiento
Tokyo Asbo ClinicChuo-kuTokyoEn reclutamiento
Medical Corp Seikoukai New Medical Research System ClinicHachioji-shiTokyoEn reclutamiento
Medical Corporation AOT Shinagawa Strings ClinicMinato-kuTokyoEn reclutamiento
Clinical Research Hospital TokyoShinjuku-kuTokyoEn reclutamiento
Medical Corporation Hanabusakai Shinei Medical Healthcare ClinicSuginami-kuTokyoEn reclutamiento
Medical Corporation Hitomikai Motomachi Takatsuka Naika ClinicYokohamaKanagawaEn reclutamiento

Puerto Rico

CentroCiudadEstado o regiónEstado
Ponce Medical School Foundation IncPonceEn reclutamiento
Puerto Rico Medical Research Inc.PonceEn reclutamiento
Latin Clinical Trial CenterSan JuanEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
Pinnacle Research Group LLCAnnistonAlabamaEn reclutamiento
Washington Center for Weight Management and Research, IncArlingtonVirginiaEn reclutamiento
Elligo Clinical Research CenterAustinTexasEn reclutamiento
Velocity Clinical Research - Baton RougeBaton RougeLouisianaEn reclutamiento
Johnson County Clinical Trials Juno BellaireBellaireTexasEn reclutamiento
Velocity Clinical Research- BinghamtonBinghamtonNew YorkEn reclutamiento
Pantheon Clinical ResearchBountifulUtahEn reclutamiento
Flourish Research - Great Lakes Clinical TrialsChicagoIllinoisEn reclutamiento
Velocity Clinical Research - CincinnatiCincinnatiOhioEn reclutamiento
Clinical Trial Investigator Clinical Research CenterCincinnatiOhioEn reclutamiento
Cedar Health Research, LLCDallasTexasEn reclutamiento
Alliance For Multispecialty Research - DaphneDaphneAlabamaEn reclutamiento
Epic Medical Research - Red OakDeSotoTexasEn reclutamiento
Velocity Clinical Research - ProvidenceEast GreenwichRhode IslandEn reclutamiento
Great Lakes Research Institute El Paso ResearchEl PasoTexasEn reclutamiento
Cedar Health Research, LLCEulessTexasEn reclutamiento
Prime Health and Wellness Sky Clinical Research Network GroupFayetteMississippiEn reclutamiento
Ark Clinical Research- TustinFountain ValleyCaliforniaEn reclutamiento
Center for Advanced Research and EducationGainesvilleGeorgiaEn reclutamiento
Tribe Clinical Research LLC Dba Mountain View Clinical ResearchGreenvilleSouth CarolinaEn reclutamiento
Accellacare of HickoryHickoryNorth CarolinaEn reclutamiento
East-West Medical ResearchHonoluluHawaiiEn reclutamiento
JCCT- Juno Northwest HoustonHoustonTexasEn reclutamiento
Biopharma Informatic, LLCHoustonTexasEn reclutamiento
Clinical Neuroscience Solutions - JacksonvilleJacksonvilleFloridaEn reclutamiento
Jacksonville Center for Clinical ResearchJacksonvilleFloridaEn reclutamiento
Alliance for Multispecialty Research - Kansas CityKansas CityMissouriEn reclutamiento
New Phase Research and DevelopmentKnoxvilleTennesseeEn reclutamiento
Vector Clinical TrialsLas VegasNevadaEn reclutamiento
Palm Research Center IncLas VegasNevadaEn reclutamiento
Alliance for Multispecialty Research Layton Research CenterLaytonUtahEn reclutamiento
Ark Clinical Research- Long BeachLong BeachCaliforniaEn reclutamiento
Long Beach Clinical Trials Services IncLong BeachCaliforniaEn reclutamiento

En el registro figuran 37 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 3 de septiembre de 2026

    Centro añadido

    4 sites added (87 total)

    8387

  2. 27 de agosto de 2026

    Centro añadido

    52 sites added (83 total)

    3183

  3. 4 de agosto de 2026

    Estado modificado

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  4. 4 de agosto de 2026

    Reclutamiento abierto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  5. 4 de agosto de 2026

    Centro añadido

    31 sites added (31 total)

    031

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07684235