xMedica

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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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 Teilnehmende gesucht87 Studienzentren4 Länder

Kategorien

Endokrin und metabolisch100%

In 1 Register registriert

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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.

Zusammenfassung

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).

Erkrankungen

  • Obesity
  • Overweight

Eignung

GeschlechtAlle
Alter18 Years – 99 Years
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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).

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungDOUBLE (2)
Teilnahme3.200 Teilnehmende gesucht

Sponsor und Mitwirkende

  • Amgen Sponsor

Studienarme und Interventionen

  • 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.

Interventionen

  • Arzneimittel Maridebart cafraglutide

    Administered subcutaneously

  • Arzneimittel Placebo

    Administered subcutaneously.

Endpunkte

  1. Primärer Endpunkt

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

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

  2. Primärer Endpunkt

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

    Zeitrahmen Baseline of current trial up to 60 weeks

  3. Sekundärer Endpunkt

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

    Zeitrahmen Baseline of parent trial to Week 48 of current trial

  4. Sekundärer Endpunkt

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

    Zeitrahmen Baseline of parent trial to Week 48 of current trial

  5. Sekundärer Endpunkt

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

    Zeitrahmen Baseline of parent trial to Week 48 of current trial

  6. Sekundärer Endpunkt

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

    Zeitrahmen Baseline of parent trial to Week 48 of current trial

  7. Sekundärer Endpunkt

    Change from Baseline of the Parent Trial in Waist Circumference

    Zeitrahmen Baseline of parent trial to Week 48 of current trial

  8. Sekundärer Endpunkt

    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

    Zeitrahmen Baseline of parent trial to Week 48 of current trial

  9. Sekundärer Endpunkt

    Percent Change from Baseline in Body Weight

    Zeitrahmen Baseline of current trial to Week 48

  10. Sekundärer Endpunkt

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

    Zeitrahmen Week 48 of current trial

  11. Sekundärer Endpunkt

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

    Zeitrahmen Week 48 of current trial

  12. Sekundärer Endpunkt

    Percentage of Body Weight Reduction Maintained from the Parent Trial

    Zeitrahmen Baseline of parent trial to Week 48 of current trial

  13. Sekundärer Endpunkt

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

    Zeitrahmen Baseline of parent trial to Week 48 of current trial

Daten

Startdatum23. Juli 2026 (tatsächlich)
Primärer Abschluss26. Dezember 2027 (geschätzt)
Abschluss19. März 2028 (geschätzt)
Erstveröffentlichung6. Juli 2026 (tatsächlich)
Zuletzt aktualisiert3. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

87 Studienzentren rekrutieren

Australia

EinrichtungStadtBundesland oder RegionStatus
Emeritus Research SydneyBotanyNew South WalesRekrutiert
Emeritus Research CamberwellCamberwellVictoriaRekrutiert
NovatrialsCharlestownNew South WalesRekrutiert
Canopy Clinical SutherlandMirandaNew South WalesRekrutiert
Canopy Clinical Altona NorthNorth AltonaVictoriaRekrutiert
Fusion Clinical ResearchNorwoodSouth AustraliaRekrutiert
Canopy Clinical WollongongWollongongNew South WalesRekrutiert

Japan

EinrichtungStadtBundesland oder RegionStatus
Doujin Memorial Foundation, Meiwa HospitalChiyoda-kuTokyoRekrutiert
Tokyo Asbo ClinicChuo-kuTokyoRekrutiert
Medical Corp Seikoukai New Medical Research System ClinicHachioji-shiTokyoRekrutiert
Medical Corporation AOT Shinagawa Strings ClinicMinato-kuTokyoRekrutiert
Clinical Research Hospital TokyoShinjuku-kuTokyoRekrutiert
Medical Corporation Hanabusakai Shinei Medical Healthcare ClinicSuginami-kuTokyoRekrutiert
Medical Corporation Hitomikai Motomachi Takatsuka Naika ClinicYokohamaKanagawaRekrutiert

Puerto Rico

EinrichtungStadtBundesland oder RegionStatus
Ponce Medical School Foundation IncPonceRekrutiert
Puerto Rico Medical Research Inc.PonceRekrutiert
Latin Clinical Trial CenterSan JuanRekrutiert

United States

EinrichtungStadtBundesland oder RegionStatus
Pinnacle Research Group LLCAnnistonAlabamaRekrutiert
Washington Center for Weight Management and Research, IncArlingtonVirginiaRekrutiert
Elligo Clinical Research CenterAustinTexasRekrutiert
Velocity Clinical Research - Baton RougeBaton RougeLouisianaRekrutiert
Johnson County Clinical Trials Juno BellaireBellaireTexasRekrutiert
Velocity Clinical Research- BinghamtonBinghamtonNew YorkRekrutiert
Pantheon Clinical ResearchBountifulUtahRekrutiert
Flourish Research - Great Lakes Clinical TrialsChicagoIllinoisRekrutiert
Velocity Clinical Research - CincinnatiCincinnatiOhioRekrutiert
Clinical Trial Investigator Clinical Research CenterCincinnatiOhioRekrutiert
Cedar Health Research, LLCDallasTexasRekrutiert
Alliance For Multispecialty Research - DaphneDaphneAlabamaRekrutiert
Epic Medical Research - Red OakDeSotoTexasRekrutiert
Velocity Clinical Research - ProvidenceEast GreenwichRhode IslandRekrutiert
Great Lakes Research Institute El Paso ResearchEl PasoTexasRekrutiert
Cedar Health Research, LLCEulessTexasRekrutiert
Prime Health and Wellness Sky Clinical Research Network GroupFayetteMississippiRekrutiert
Ark Clinical Research- TustinFountain ValleyCaliforniaRekrutiert
Center for Advanced Research and EducationGainesvilleGeorgiaRekrutiert
Tribe Clinical Research LLC Dba Mountain View Clinical ResearchGreenvilleSouth CarolinaRekrutiert
Accellacare of HickoryHickoryNorth CarolinaRekrutiert
East-West Medical ResearchHonoluluHawaiiRekrutiert
JCCT- Juno Northwest HoustonHoustonTexasRekrutiert
Biopharma Informatic, LLCHoustonTexasRekrutiert
Clinical Neuroscience Solutions - JacksonvilleJacksonvilleFloridaRekrutiert
Jacksonville Center for Clinical ResearchJacksonvilleFloridaRekrutiert
Alliance for Multispecialty Research - Kansas CityKansas CityMissouriRekrutiert
New Phase Research and DevelopmentKnoxvilleTennesseeRekrutiert
Vector Clinical TrialsLas VegasNevadaRekrutiert
Palm Research Center IncLas VegasNevadaRekrutiert
Alliance for Multispecialty Research Layton Research CenterLaytonUtahRekrutiert
Ark Clinical Research- Long BeachLong BeachCaliforniaRekrutiert
Long Beach Clinical Trials Services IncLong BeachCaliforniaRekrutiert

37 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 3. September 2026

    Studienzentrum hinzugefügt

    4 sites added (87 total)

    8387

  2. 27. August 2026

    Studienzentrum hinzugefügt

    52 sites added (83 total)

    3183

  3. 4. August 2026

    Status geändert

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  4. 4. August 2026

    Rekrutierung eröffnet

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  5. 4. August 2026

    Studienzentrum hinzugefügt

    31 sites added (31 total)

    031

Register: ClinicalTrials.gov · NCT########

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