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NCT07684144ClinicalTrials.gov

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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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).

المرحلة 3مطلوب 950 مشاركاً37 موقعاً3 دول

الفئات

الغدد الصمّاء والأيض100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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 2026-07-29
  • 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 3 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-centre0/8

    Single site, or site count not stated

  • 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

ScaleMEDIUM

A medium-sized study, international in scope: 950 participants (target), run at 37 sites, across 3 countries.

How this score is built
  • Enrolment29/40

    950 participants (target)

  • Site count0/25

    Site count not stated in the record

  • Country count0/15

    Country count not stated in the record

  • 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.

ملخص

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).

الحالات

  • Obesity
  • Overweight
  • Diabetes Mellitus, Type 2

الأهلية

الجنسالجميع
الأعمار18 Years – 99 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

Inclusion Criteria: * Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol. * 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. * Participants must use protocol-specified contraception during treatment and for 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 (BMI) ≤ 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 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 * 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). * Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization. * 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. * 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, 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).

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةDOUBLE (2)
التجنيدمطلوب 950 مشاركاً

الجهة الراعية والمتعاونون

  • Amgen الجهة الراعية

الأذرع والتدخلات

  • Maridebart Cafraglutide Low Dose Q4WEXPERIMENTAL

    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).

  • 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 8 weeks (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.

  • 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.

التدخلات

  • دواء Maridebart Cafraglutide

    Administered subcutaneously.

  • دواء Placebo

    Administered subcutaneously.

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Percent Change in Body Weight from Baseline of the Parent Trial (20210184)

    الإطار الزمني Baseline of parent trial (20210184) to Week 48 of current trial

  2. مقياس النتيجة الأولي

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

    الإطار الزمني Baseline of current trial up to 60 weeks

  3. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  4. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  5. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  6. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  7. مقياس النتيجة الثانوي

    Change from Baseline of the Parent Trial in Hemoglobin A1c

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  8. مقياس النتيجة الثانوي

    Change from Baseline of the Parent Trial in Waist Circumference

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  9. مقياس النتيجة الثانوي

    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

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  10. مقياس النتيجة الثانوي

    Percent Change from Baseline in Body Weight

    الإطار الزمني Baseline of current trial to Week 48

  11. مقياس النتيجة الثانوي

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

    الإطار الزمني Week 48 of current trial

  12. مقياس النتيجة الثانوي

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

    الإطار الزمني Week 48 of current trial

  13. مقياس النتيجة الثانوي

    Percentage of Body Weight Reduction Maintained from the Parent Trial

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  14. مقياس النتيجة الثانوي

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

    الإطار الزمني Baseline of parent trial to Week 48 of current trial

  15. مقياس النتيجة الثانوي

    Change from Baseline in HbA1c

    الإطار الزمني Week 48 of current trial

التواريخ

تاريخ البدء29 يوليو 2026 (فعلي)
الإتمام الأولي26 ديسمبر 2027 (تقديري)
الإتمام19 مارس 2028 (تقديري)
أول نشر6 يوليو 2026 (فعلي)
آخر تحديث3 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

37 موقعاً قيد التجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Shiraiwa Medical ClinicKashiwara-shiOsakaقيد التجنيد
Morizono Medical ClinicKitakyusyu-shiFukuokaقيد التجنيد
Morinaga Ueno ClinicKumamotoKumamotoقيد التجنيد
Mikannohana Clinic, Diabetes, Endocrinology and MetabolismMatsuyamaEhimeقيد التجنيد
Medical Corporation Ouitsukai Kanno NaikaMitaka-shiTokyoقيد التجنيد
Nakamoto Medical ClinicMitoIbarakiقيد التجنيد
Nakakinen ClinicNakaIbarakiقيد التجنيد
Suruga ClinicShizuokaShizuokaقيد التجنيد
Ohishi Naika ClinicTsuchiura-shiIbarakiقيد التجنيد

Puerto Rico

المنشأةالمدينةالولاية أو المنطقةالحالة
Latin Clinical Trial CenterSan Juanقيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Elligo Clinical Research CenterAustinTexasقيد التجنيد
Johnson County Clinical Trials Juno BellaireBellaireTexasقيد التجنيد
San Fernando Valley Health InstituteCanoga ParkCaliforniaقيد التجنيد
Core Healthcare GroupCerritosCaliforniaقيد التجنيد
Velocity Clinical Research Chula VistaChula VistaCaliforniaقيد التجنيد
Velocity Clinical Research - CincinnatiCincinnatiOhioقيد التجنيد
Velocity Clinical Research - SpringdaleCincinnatiOhioقيد التجنيد
Osvaldo A Brusco MD PACorpus ChristiTexasقيد التجنيد
Soma Clinical Trials, LLCDenisonTexasقيد التجنيد
Velocity Clinical Research - ProvidenceEast GreenwichRhode Islandقيد التجنيد
Gilbert Center for Family MedicineGilbertArizonaقيد التجنيد
JCCT- Juno Northwest HoustonHoustonTexasقيد التجنيد
Alliance for Multispecialty Research - Kansas CityKansas CityMissouriقيد التجنيد
Palm Research Center IncLas VegasNevadaقيد التجنيد
Manassas Clinical Research Center IncManassasVirginiaقيد التجنيد
Optimus U CorporationMiamiFloridaقيد التجنيد
Indago Research and Health CenterMiami LakesFloridaقيد التجنيد
San Marcus Research Clinic IncMiami LakesFloridaقيد التجنيد
West Clinical ResearchMorehead CityNorth Carolinaقيد التجنيد
Alliance for Multispecialty Research NewtonNewtonKansasقيد التجنيد
Florida Institute for Clinical ResearchOrlandoFloridaقيد التجنيد
Empire Clinical ResearchPomonaCaliforniaقيد التجنيد
Premier ResearchTrentonNew Jerseyقيد التجنيد
Iowa Diabetes ResearchWest Des MoinesIowaقيد التجنيد
Encore Medical Research of Weston LLCWestonFloridaقيد التجنيد
Alliance for Multispecialty Research LLCWichitaKansasقيد التجنيد
Conquest Research - Winter ParkWinter ParkFloridaقيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 27 أغسطس 2026

    أُضيف موقع

    13 sites added (37 total)

    2437

  2. 24 أغسطس 2026

    تغيّرت الحالة

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  3. 24 أغسطس 2026

    فُتح التجنيد

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  4. 24 أغسطس 2026

    أُضيف موقع

    24 sites added (24 total)

    024

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07684144