Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
1. oktober 2026 opdateret af: Amgen
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
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).
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
3200
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-mail: medinfo@amgen.com
Studiesteder
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New South Wales
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Botany, New South Wales, Australien, 2019
- Rekruttering
- Emeritus Research Sydney
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Charlestown, New South Wales, Australien, 2290
- Rekruttering
- Novatrials
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Miranda, New South Wales, Australien, 2228
- Rekruttering
- Canopy Clinical Sutherland
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Miranda, New South Wales, Australien, 2228
- Rekruttering
- Canopy Clinical Wollongong
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Queensland
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Meadowbrook, Queensland, Australien, 4131
- Rekruttering
- Logan Hospital
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SAU
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Adelaide, SAU, Australien, 5000
- Rekruttering
- Fusion Clinical Research
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Victoria
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Camberwell, Victoria, Australien, 3124
- Rekruttering
- Emeritus Research Camberwell
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North Altona, Victoria, Australien, 3025
- Rekruttering
- Canopy Clinical Altona North
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Ontario
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Hamilton, Ontario, Canada, L8L 5G8
- Rekruttering
- Wharton Medical Clinic
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Thunder Bay, Ontario, Canada, P7B 6V4
- Rekruttering
- Curans Heart Center
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7K9
- Rekruttering
- Ecogene-21
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Alabama
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Anniston, Alabama, Forenede Stater, 36207
- Rekruttering
- Pinnacle Research Group LLC
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Daphne, Alabama, Forenede Stater, 36526
- Rekruttering
- Alliance For Multispecialty Research - Daphne
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Mobile, Alabama, Forenede Stater, 36608
- Rekruttering
- Alliance for Multispecialty Research Mobile
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California
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Fountain Valley, California, Forenede Stater, 92708
- Rekruttering
- Ark Clinical Research- Tustin
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Long Beach, California, Forenede Stater, 90806
- Rekruttering
- Long Beach Clinical Trials Services Inc
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Long Beach, California, Forenede Stater, 90815
- Rekruttering
- Ark Clinical Research- Long Beach
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Montclair, California, Forenede Stater, 91763
- Rekruttering
- Catalina Research Institute
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Riverside, California, Forenede Stater, 92503
- Rekruttering
- Artemis Institute for Clinical Research
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San Diego, California, Forenede Stater, 92103
- Rekruttering
- Artemis Institute for Clinical Research
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San Diego, California, Forenede Stater, 92120
- Rekruttering
- Apex Clinical Research
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Santa Ana, California, Forenede Stater, 92701
- Rekruttering
- Southern California Clinical Research
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Walnut Creek, California, Forenede Stater, 94598
- Rekruttering
- Diablo Clinical Research
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Connecticut
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Waterbury, Connecticut, Forenede Stater, 06708
- Rekruttering
- Chase Medical Research LLC
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Florida
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Jacksonville, Florida, Forenede Stater, 32216
- Rekruttering
- Jacksonville Center for Clinical Research
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Jacksonville, Florida, Forenede Stater, 32256
- Rekruttering
- Clinical Neuroscience Solutions - Jacksonville
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Lauderhill, Florida, Forenede Stater, 33351
- Rekruttering
- South Florida Wellness and Clinical Research Institute
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Miami, Florida, Forenede Stater, 33173
- Rekruttering
- Research Institute of South Florida
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Miami, Florida, Forenede Stater, 33135
- Rekruttering
- Optimus U Corporation
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Miami Lakes, Florida, Forenede Stater, 33016
- Rekruttering
- Indago Research and Health Center
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Ocala, Florida, Forenede Stater, 34470
- Rekruttering
- Renstar Medical Research
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Orlando, Florida, Forenede Stater, 32801
- Rekruttering
- Clinical Neuroscience Solutions - Orlando
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Orlando, Florida, Forenede Stater, 32825
- Rekruttering
- Florida Institute for Clinical Research
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Orlando, Florida, Forenede Stater, 32807
- Rekruttering
- Combined Research Orlando Phase I IV
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Weston, Florida, Forenede Stater, 33331
- Rekruttering
- Encore Medical Research of Weston LLC
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Georgia
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Gainesville, Georgia, Forenede Stater, 30501
- Rekruttering
- Center for Advanced Research and Education
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Union City, Georgia, Forenede Stater, 30291
- Rekruttering
- Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96814
- Rekruttering
- East-West Medical Research
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Idaho
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Meridian, Idaho, Forenede Stater, 83646
- Rekruttering
- Solaris Clinical Research
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
- Rekruttering
- Flourish Research - Great Lakes Clinical Trials
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Skokie, Illinois, Forenede Stater, 60077
- Rekruttering
- Evanston Premier Healthcare Research LLC
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Skokie, Illinois, Forenede Stater, 60077
- Rekruttering
- Endeavor Health
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Kansas
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Lenexa, Kansas, Forenede Stater, 66219
- Rekruttering
- JCCT- Juno Northwest Houston
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Newton, Kansas, Forenede Stater, 67114
- Rekruttering
- Alliance for Multispecialty Research Newton
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40213
- Rekruttering
- Louisville Metabolic and Atherosclerosis Research Center
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Rekruttering
- Velocity Clinical Research - Baton Rouge
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Marrero, Louisiana, Forenede Stater, 70072
- Rekruttering
- Tandem Clinical Research - Marrero
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Michigan
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Southfield, Michigan, Forenede Stater, 48034
- Rekruttering
- Headlands Research - Detroit
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Mississippi
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Fayette, Mississippi, Forenede Stater, 39069
- Rekruttering
- Prime Health and Wellness Sky Clinical Research Network Group
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Missouri
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Kansas City, Missouri, Forenede Stater, 64114
- Rekruttering
- Alliance for Multispecialty Research - Kansas City
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89128
- Rekruttering
- Vector Clinical Trials
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Las Vegas, Nevada, Forenede Stater, 89148
- Rekruttering
- Palm Research Center Inc
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New York
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Binghamton, New York, Forenede Stater, 13905
- Rekruttering
- Velocity Clinical Research- Binghamton
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Rochester, New York, Forenede Stater, 14609
- Rekruttering
- Rochester Clinical Research
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North Carolina
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Hickory, North Carolina, Forenede Stater, 28602
- Rekruttering
- Accellacare of Hickory
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Shelby, North Carolina, Forenede Stater, 28150
- Rekruttering
- Carolina Research Center Inc
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- Velocity Clinical Research - Cincinnati
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Cincinnati, Ohio, Forenede Stater, 45212
- Rekruttering
- Clinical Trial Investigator Clinical Research Center
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Oklahoma
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Norman, Oklahoma, Forenede Stater, 73069
- Rekruttering
- Alliance for Multispecialty Research - Norman
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Pennsylvania
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Newport, Pennsylvania, Forenede Stater, 17074
- Rekruttering
- Capital Area Research LLC
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Rhode Island
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East Greenwich, Rhode Island, Forenede Stater, 02818
- Rekruttering
- Velocity Clinical Research - Providence
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Rekruttering
- Tribe Clinical Research LLC Dba Mountain View Clinical Research
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37909
- Rekruttering
- New Phase Research and Development
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Knoxville, Tennessee, Forenede Stater, 37938
- Rekruttering
- Accellacare US Inc., d/b/a Accellacare of Knoxville
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Texas
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Austin, Texas, Forenede Stater, 78704
- Rekruttering
- Elligo Clinical Research Center
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Bellaire, Texas, Forenede Stater, 77401
- Rekruttering
- Johnson County Clinical Trials Juno Bellaire
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Dallas, Texas, Forenede Stater, 75251
- Rekruttering
- Cedar Health Research, LLC
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Dallas, Texas, Forenede Stater, 75235
- Rekruttering
- Cedar Health Research, LLC
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DeSoto, Texas, Forenede Stater, 75115
- Rekruttering
- Epic Medical Research - Red Oak
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El Paso, Texas, Forenede Stater, 79905
- Rekruttering
- Great Lakes Research Institute El Paso Research
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Houston, Texas, Forenede Stater, 77043
- Rekruttering
- Biopharma Informatic, LLC
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Mesquite, Texas, Forenede Stater, 75149
- Rekruttering
- Southern Endocrinology Associates PA
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Pharr, Texas, Forenede Stater, 78557
- Rekruttering
- Great Lakes Research Institute - McAllen Research
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- Clinical Trials of Texas
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Sugar Land, Texas, Forenede Stater, 77479
- Rekruttering
- Sugar Lakes Family Practice
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Utah
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Bountiful, Utah, Forenede Stater, 84010
- Rekruttering
- Pantheon Clinical Research
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Layton, Utah, Forenede Stater, 84041
- Rekruttering
- Alliance for Multispecialty Research Layton Research Center
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St. George, Utah, Forenede Stater, 84790
- Rekruttering
- Chrysalis Clinical Research, LLC
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Virginia
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Arlington, Virginia, Forenede Stater, 22206
- Rekruttering
- Washington Center for Weight Management and Research, Inc
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Newport News, Virginia, Forenede Stater, 23606
- Rekruttering
- Health Research of Hampton Roads
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Winchester, Virginia, Forenede Stater, 22601
- Rekruttering
- Selma Medical Associates
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Wisconsin
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Wauwatosa, Wisconsin, Forenede Stater, 53226
- Rekruttering
- Allegiance Research Specialists
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Kanagawa
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Yokohama, Kanagawa, Japan, 231-0023
- Rekruttering
- Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
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Tokyo
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Chiyoda-ku, Tokyo, Japan, 101-0041
- Rekruttering
- Doujin Memorial Foundation, Meiwa Hospital
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Chuo-ku, Tokyo, Japan, 104-0031
- Rekruttering
- Tokyo Asbo Clinic
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Hachioji-shi, Tokyo, Japan, 192-0046
- Rekruttering
- Medical Corp Seikoukai New Medical Research System Clinic
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Minato-ku, Tokyo, Japan, 108-0075
- Rekruttering
- Medical Corporation AOT Shinagawa Strings Clinic
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Shinjuku-ku, Tokyo, Japan, 160-0004
- Rekruttering
- Clinical Research Hospital Tokyo
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Suginami-ku, Tokyo, Japan, 166-0003
- Rekruttering
- Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
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Ponce, Puerto Rico, 00716
- Rekruttering
- Ponce Medical School Foundation Inc
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Ponce, Puerto Rico, 00717
- Rekruttering
- Puerto Rico Medical Research Inc.
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San Juan, Puerto Rico, 00909
- Rekruttering
- Latin Clinical Trial Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 99 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
10
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Maridebart Cafraglutide Medium Dose Q4W
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. |
Administered subcutaneously
Andre navne:
|
|
Placebo komparator: Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)
Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W. |
Administered subcutaneously. |
|
Eksperimentel: Maridebart Cafraglutide High Dose Q4W
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. |
Administered subcutaneously
Andre navne:
|
|
Eksperimentel: Maridebart Cafraglutide High Dose Q8W
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. |
Administered subcutaneously
Andre navne:
|
|
Placebo komparator: Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)
Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W. |
Administered subcutaneously. |
|
Eksperimentel: Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)
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. |
Administered subcutaneously
Andre navne:
|
|
Eksperimentel: Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)
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. |
Administered subcutaneously
Andre navne:
|
|
Eksperimentel: Maridebart Cafraglutide Low Dose Q4W
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). |
Administered subcutaneously
Andre navne:
|
|
Eksperimentel: Maridebart Cafraglutide Medium Dose Q8W
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). |
Administered subcutaneously
Andre navne:
|
|
Eksperimentel: Maridebart Cafraglutide High Dose Q12W
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). |
Administered subcutaneously
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent Change in Body Weight from Baseline of the Parent Trial (20210181)
Tidsramme: Baseline of parent trial (20210181) to Week 48 of current trial
|
Baseline of parent trial (20210181) to Week 48 of current trial
|
|
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline of current trial up to 60 weeks
|
Baseline of current trial up to 60 weeks
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants Achieving ≥5% Reduction in Body Weight from Baseline of the Parent Trial
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline of the Parent Trial
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline of the Parent Trial
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percentage of Participants Achieving ≥20% Reduction in Body Weight from Baseline of the Parent Trial
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Change from Baseline of the Parent Trial in Waist Circumference
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
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
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percent Change from Baseline in Body Weight
Tidsramme: Baseline of current trial to Week 48
|
Baseline of current trial to Week 48
|
|
Percentage of Participants with No Body Weight Gain of >3% From Baseline
Tidsramme: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Participants with No Body Weight Gain of >5% From Baseline
Tidsramme: Week 48 of current trial
|
Week 48 of current trial
|
|
Percentage of Body Weight Reduction Maintained from the Parent Trial
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
|
Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial
Tidsramme: Baseline of parent trial to Week 48 of current trial
|
Baseline of parent trial to Week 48 of current trial
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: MD, Amgen
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
23. juli 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
26. december 2027
Studieafslutning (Anslået)
Studieafslutning
19. marts 2028
Datoer for studieregistrering
Først indsendt
Først indsendt
29. juni 2026
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
29. juni 2026
Først opslået (Faktiske)
Først opslået
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
5. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. oktober 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 20250197
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD-delingstidsramme
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD-delingsadgangskriterier
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .