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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

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.
יצירת קשר עם המחקר

בקצרה

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).

שלב 3דרושים 950 משתתפים37 אתרים3 מדינות

קטגוריות

אנדוקריני ומטבולי100%

רשום במרשם אחד

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

מתעניינים במחקר הזה?

התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

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.

תקציר

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).

מצבים רפואיים

  • Obesity
  • Overweight
  • Diabetes Mellitus, Type 2

זכאות

מיןהכול
גילאים18 Years – 99 Years
מתנדבים בריאיםלא

זכאות כפי שנכתבה במרשם

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).

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

סוג המחקרהתערבותי
שלבשלב 3
הקצאהאקראי
מודל ההתערבותPARALLEL
מטרה ראשיתTREATMENT
הסתרהDOUBLE (2)
גיוסדרושים 950 משתתפים

נותן חסות ושותפים

  • Amgen נותן חסות

זרועות והתערבויות

  • 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.

התערבויות

  • תרופה Maridebart Cafraglutide

    Administered subcutaneously.

  • תרופה Placebo

    Administered subcutaneously.

מדדי תוצאה

  1. מדד תוצאה ראשוני

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

    מסגרת זמן Baseline of parent trial (20210184) to Week 48 of current trial

  2. מדד תוצאה ראשוני

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

    מסגרת זמן Baseline of current trial up to 60 weeks

  3. מדד תוצאה משני

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

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  4. מדד תוצאה משני

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

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  5. מדד תוצאה משני

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

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  6. מדד תוצאה משני

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

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  7. מדד תוצאה משני

    Change from Baseline of the Parent Trial in Hemoglobin A1c

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  8. מדד תוצאה משני

    Change from Baseline of the Parent Trial in Waist Circumference

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  9. מדד תוצאה משני

    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

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  10. מדד תוצאה משני

    Percent Change from Baseline in Body Weight

    מסגרת זמן Baseline of current trial to Week 48

  11. מדד תוצאה משני

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

    מסגרת זמן Week 48 of current trial

  12. מדד תוצאה משני

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

    מסגרת זמן Week 48 of current trial

  13. מדד תוצאה משני

    Percentage of Body Weight Reduction Maintained from the Parent Trial

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  14. מדד תוצאה משני

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

    מסגרת זמן Baseline of parent trial to Week 48 of current trial

  15. מדד תוצאה משני

    Change from Baseline in HbA1c

    מסגרת זמן Week 48 of current trial

תאריכים

תאריך התחלה29 ביולי 2026 (בפועל)
סיום ראשוני26 בדצמבר 2027 (משוער)
סיום19 במרץ 2028 (משוער)
פורסם לראשונה6 ביולי 2026 (בפועל)
עודכן לאחרונה3 בספטמבר 2026
התוצאות פורסמולא צוין ברשומת המרשם
המצב אומת לאחרונהספטמבר 2026

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

37 אתרים מגייסים

Japan

מתקןעירמדינה או אזורמצב
Shiraiwa Medical ClinicKashiwara-shiOsakaמגייס
Morizono Medical ClinicKitakyusyu-shiFukuokaמגייס
Morinaga Ueno ClinicKumamotoKumamotoמגייס
Mikannohana Clinic, Diabetes, Endocrinology and MetabolismMatsuyamaEhimeמגייס
Medical Corporation Ouitsukai Kanno NaikaMitaka-shiTokyoמגייס
Nakamoto Medical ClinicMitoIbarakiמגייס
Nakakinen ClinicNakaIbarakiמגייס
Suruga ClinicShizuokaShizuokaמגייס
Ohishi Naika ClinicTsuchiura-shiIbarakiמגייס

Puerto Rico

מתקןעירמדינה או אזורמצב
Latin Clinical Trial CenterSan Juanמגייס

United States

מתקןעירמדינה או אזורמצב
Elligo Clinical Research CenterAustinTexasמגייס
Johnson County Clinical Trials Juno BellaireBellaireTexasמגייס
San Fernando Valley Health InstituteCanoga ParkCaliforniaמגייס
Core Healthcare GroupCerritosCaliforniaמגייס
Velocity Clinical Research Chula VistaChula VistaCaliforniaמגייס
Velocity Clinical Research - CincinnatiCincinnatiOhioמגייס
Velocity Clinical Research - SpringdaleCincinnatiOhioמגייס
Osvaldo A Brusco MD PACorpus ChristiTexasמגייס
Soma Clinical Trials, LLCDenisonTexasמגייס
Velocity Clinical Research - ProvidenceEast GreenwichRhode Islandמגייס
Gilbert Center for Family MedicineGilbertArizonaמגייס
JCCT- Juno Northwest HoustonHoustonTexasמגייס
Alliance for Multispecialty Research - Kansas CityKansas CityMissouriמגייס
Palm Research Center IncLas VegasNevadaמגייס
Manassas Clinical Research Center IncManassasVirginiaמגייס
Optimus U CorporationMiamiFloridaמגייס
Indago Research and Health CenterMiami LakesFloridaמגייס
San Marcus Research Clinic IncMiami LakesFloridaמגייס
West Clinical ResearchMorehead CityNorth Carolinaמגייס
Alliance for Multispecialty Research NewtonNewtonKansasמגייס
Florida Institute for Clinical ResearchOrlandoFloridaמגייס
Empire Clinical ResearchPomonaCaliforniaמגייס
Premier ResearchTrentonNew Jerseyמגייס
Iowa Diabetes ResearchWest Des MoinesIowaמגייס
Encore Medical Research of Weston LLCWestonFloridaמגייס
Alliance for Multispecialty Research LLCWichitaKansasמגייס
Conquest Research - Winter ParkWinter ParkFloridaמגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

  1. 27 באוגוסט 2026

    אתר נוסף

    13 sites added (37 total)

    2437

  2. 24 באוגוסט 2026

    המצב השתנה

    Status changed from Not yet recruiting to Recruiting

    NOT_YET_RECRUITINGRECRUITING

  3. 24 באוגוסט 2026

    הגיוס נפתח

    Recruitment opened

    NOT_YET_RECRUITINGRECRUITING

  4. 24 באוגוסט 2026

    אתר נוסף

    24 sites added (24 total)

    024

מרשם: ClinicalTrials.gov · NCT########

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