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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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).

Phase 33 200 participants recherchés87 sites4 pays

Catégories

Endocrinien et métabolique100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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).

Affections

  • Obesity
  • Overweight

Éligibilité

SexeTous
Âges18 Years – 99 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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).

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuDOUBLE (2)
Recrutement3 200 participants recherchés

Promoteur et collaborateurs

  • Amgen Promoteur

Groupes et interventions

  • 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.

Interventions

  • Médicament Maridebart cafraglutide

    Administered subcutaneously

  • Médicament Placebo

    Administered subcutaneously.

Critères de jugement

  1. Critère de jugement principal

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

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

  2. Critère de jugement principal

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

    Délai Baseline of current trial up to 60 weeks

  3. Critère de jugement secondaire

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

    Délai Baseline of parent trial to Week 48 of current trial

  4. Critère de jugement secondaire

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

    Délai Baseline of parent trial to Week 48 of current trial

  5. Critère de jugement secondaire

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

    Délai Baseline of parent trial to Week 48 of current trial

  6. Critère de jugement secondaire

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

    Délai Baseline of parent trial to Week 48 of current trial

  7. Critère de jugement secondaire

    Change from Baseline of the Parent Trial in Waist Circumference

    Délai Baseline of parent trial to Week 48 of current trial

  8. Critère de jugement secondaire

    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

    Délai Baseline of parent trial to Week 48 of current trial

  9. Critère de jugement secondaire

    Percent Change from Baseline in Body Weight

    Délai Baseline of current trial to Week 48

  10. Critère de jugement secondaire

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

    Délai Week 48 of current trial

  11. Critère de jugement secondaire

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

    Délai Week 48 of current trial

  12. Critère de jugement secondaire

    Percentage of Body Weight Reduction Maintained from the Parent Trial

    Délai Baseline of parent trial to Week 48 of current trial

  13. Critère de jugement secondaire

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

    Délai Baseline of parent trial to Week 48 of current trial

Dates

Date de début23 juillet 2026 (réelle)
Achèvement principal26 décembre 2027 (estimée)
Achèvement19 mars 2028 (estimée)
Première publication6 juillet 2026 (réelle)
Dernière mise à jour3 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

87 sites sont en recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Emeritus Research SydneyBotanyNew South WalesEn recrutement
Emeritus Research CamberwellCamberwellVictoriaEn recrutement
NovatrialsCharlestownNew South WalesEn recrutement
Canopy Clinical SutherlandMirandaNew South WalesEn recrutement
Canopy Clinical Altona NorthNorth AltonaVictoriaEn recrutement
Fusion Clinical ResearchNorwoodSouth AustraliaEn recrutement
Canopy Clinical WollongongWollongongNew South WalesEn recrutement

Japan

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

Puerto Rico

ÉtablissementVilleÉtat ou régionStatut
Ponce Medical School Foundation IncPonceEn recrutement
Puerto Rico Medical Research Inc.PonceEn recrutement
Latin Clinical Trial CenterSan JuanEn recrutement

United States

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

37 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 3 septembre 2026

    Site ajouté

    4 sites added (87 total)

    8387

  2. 27 août 2026

    Site ajouté

    52 sites added (83 total)

    3183

  3. 4 août 2026

    Statut modifié

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  4. 4 août 2026

    Recrutement ouvert

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  5. 4 août 2026

    Site ajouté

    31 sites added (31 total)

    031

Registre: ClinicalTrials.gov · NCT########

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