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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati87 centri4 paesi

Categorie

Endocrino e metabolico100%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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).

Patologie

  • Obesity
  • Overweight

Idoneità

SessoTutti
Età18 Years – 99 Years
Volontari saniNo

Idoneità come riportata nel 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).

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseFase 3
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoDOUBLE (2)
Arruolamento3200 partecipanti ricercati

Sponsor e collaboratori

  • Amgen Sponsor

Bracci e interventi

  • 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.

Interventi

  • Farmaco Maridebart cafraglutide

    Administered subcutaneously

  • Farmaco Placebo

    Administered subcutaneously.

Esiti misurati

  1. Esito primario

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

    Orizzonte temporale Baseline of parent trial (20210181) to Week 48 of current trial

  2. Esito primario

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

    Orizzonte temporale Baseline of current trial up to 60 weeks

  3. Esito secondario

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

    Orizzonte temporale Baseline of parent trial to Week 48 of current trial

  4. Esito secondario

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

    Orizzonte temporale Baseline of parent trial to Week 48 of current trial

  5. Esito secondario

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

    Orizzonte temporale Baseline of parent trial to Week 48 of current trial

  6. Esito secondario

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

    Orizzonte temporale Baseline of parent trial to Week 48 of current trial

  7. Esito secondario

    Change from Baseline of the Parent Trial in Waist Circumference

    Orizzonte temporale Baseline of parent trial to Week 48 of current trial

  8. Esito secondario

    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

    Orizzonte temporale Baseline of parent trial to Week 48 of current trial

  9. Esito secondario

    Percent Change from Baseline in Body Weight

    Orizzonte temporale Baseline of current trial to Week 48

  10. Esito secondario

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

    Orizzonte temporale Week 48 of current trial

  11. Esito secondario

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

    Orizzonte temporale Week 48 of current trial

  12. Esito secondario

    Percentage of Body Weight Reduction Maintained from the Parent Trial

    Orizzonte temporale Baseline of parent trial to Week 48 of current trial

  13. Esito secondario

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

    Orizzonte temporale Baseline of parent trial to Week 48 of current trial

Date

Data di inizio23 luglio 2026 (effettiva)
Conclusione primaria26 dicembre 2027 (stimata)
Conclusione19 marzo 2028 (stimata)
Prima pubblicazione6 luglio 2026 (effettiva)
Ultimo aggiornamento3 settembre 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltasettembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

87 centri stanno reclutando

Australia

StrutturaCittàStato o regioneStato
Emeritus Research SydneyBotanyNew South WalesIn reclutamento
Emeritus Research CamberwellCamberwellVictoriaIn reclutamento
NovatrialsCharlestownNew South WalesIn reclutamento
Canopy Clinical SutherlandMirandaNew South WalesIn reclutamento
Canopy Clinical Altona NorthNorth AltonaVictoriaIn reclutamento
Fusion Clinical ResearchNorwoodSouth AustraliaIn reclutamento
Canopy Clinical WollongongWollongongNew South WalesIn reclutamento

Japan

StrutturaCittàStato o regioneStato
Doujin Memorial Foundation, Meiwa HospitalChiyoda-kuTokyoIn reclutamento
Tokyo Asbo ClinicChuo-kuTokyoIn reclutamento
Medical Corp Seikoukai New Medical Research System ClinicHachioji-shiTokyoIn reclutamento
Medical Corporation AOT Shinagawa Strings ClinicMinato-kuTokyoIn reclutamento
Clinical Research Hospital TokyoShinjuku-kuTokyoIn reclutamento
Medical Corporation Hanabusakai Shinei Medical Healthcare ClinicSuginami-kuTokyoIn reclutamento
Medical Corporation Hitomikai Motomachi Takatsuka Naika ClinicYokohamaKanagawaIn reclutamento

Puerto Rico

StrutturaCittàStato o regioneStato
Ponce Medical School Foundation IncPonceIn reclutamento
Puerto Rico Medical Research Inc.PonceIn reclutamento
Latin Clinical Trial CenterSan JuanIn reclutamento

United States

StrutturaCittàStato o regioneStato
Pinnacle Research Group LLCAnnistonAlabamaIn reclutamento
Washington Center for Weight Management and Research, IncArlingtonVirginiaIn reclutamento
Elligo Clinical Research CenterAustinTexasIn reclutamento
Velocity Clinical Research - Baton RougeBaton RougeLouisianaIn reclutamento
Johnson County Clinical Trials Juno BellaireBellaireTexasIn reclutamento
Velocity Clinical Research- BinghamtonBinghamtonNew YorkIn reclutamento
Pantheon Clinical ResearchBountifulUtahIn reclutamento
Flourish Research - Great Lakes Clinical TrialsChicagoIllinoisIn reclutamento
Velocity Clinical Research - CincinnatiCincinnatiOhioIn reclutamento
Clinical Trial Investigator Clinical Research CenterCincinnatiOhioIn reclutamento
Cedar Health Research, LLCDallasTexasIn reclutamento
Alliance For Multispecialty Research - DaphneDaphneAlabamaIn reclutamento
Epic Medical Research - Red OakDeSotoTexasIn reclutamento
Velocity Clinical Research - ProvidenceEast GreenwichRhode IslandIn reclutamento
Great Lakes Research Institute El Paso ResearchEl PasoTexasIn reclutamento
Cedar Health Research, LLCEulessTexasIn reclutamento
Prime Health and Wellness Sky Clinical Research Network GroupFayetteMississippiIn reclutamento
Ark Clinical Research- TustinFountain ValleyCaliforniaIn reclutamento
Center for Advanced Research and EducationGainesvilleGeorgiaIn reclutamento
Tribe Clinical Research LLC Dba Mountain View Clinical ResearchGreenvilleSouth CarolinaIn reclutamento
Accellacare of HickoryHickoryNorth CarolinaIn reclutamento
East-West Medical ResearchHonoluluHawaiiIn reclutamento
JCCT- Juno Northwest HoustonHoustonTexasIn reclutamento
Biopharma Informatic, LLCHoustonTexasIn reclutamento
Clinical Neuroscience Solutions - JacksonvilleJacksonvilleFloridaIn reclutamento
Jacksonville Center for Clinical ResearchJacksonvilleFloridaIn reclutamento
Alliance for Multispecialty Research - Kansas CityKansas CityMissouriIn reclutamento
New Phase Research and DevelopmentKnoxvilleTennesseeIn reclutamento
Vector Clinical TrialsLas VegasNevadaIn reclutamento
Palm Research Center IncLas VegasNevadaIn reclutamento
Alliance for Multispecialty Research Layton Research CenterLaytonUtahIn reclutamento
Ark Clinical Research- Long BeachLong BeachCaliforniaIn reclutamento
Long Beach Clinical Trials Services IncLong BeachCaliforniaIn reclutamento

Nella scheda del registro sono indicati altri 37 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

  1. 3 settembre 2026

    Centro aggiunto

    4 sites added (87 total)

    8387

  2. 27 agosto 2026

    Centro aggiunto

    52 sites added (83 total)

    3183

  3. 4 agosto 2026

    Stato modificato

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  4. 4 agosto 2026

    Reclutamento aperto

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  5. 4 agosto 2026

    Centro aggiunto

    31 sites added (31 total)

    031

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

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