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AzTrials

Early Alzheimer's DiseasePhase 2NCT07033494

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

A Phase 2 study testing MK-2214 in people with Early Alzheimer's Disease, run by Merck Sharp & Dohme LLC at 80 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Early Alzheimer's Disease
What is being tested?
MK-2214
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
340 participants
Where
80 sitesin 11 countries
Study dates
16 Jul 2025to 30 Apr 2030
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Has mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD)
  • Has a designated study partner who can fulfill the requirements of this study
  • If on an approved AD therapy for symptomatic AD, the dosing regimen must have been stable for 3 months prior to screening

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has a known history of stroke or cerebrovascular disease
  • Has diagnosis of a clinically relevant central nervous system disease other than AD or other condition that negatively impacts cognition or cognitive status chronically
  • Has structural brain disease
  • Has a history of seizures or epilepsy within 5 years before screening
  • Has any other major central nervous system trauma, or infections that affect brain function
Show all 15Show fewer
  • Has major medical illness or unstable medical condition within 3 months before screening
  • Has a severe, acute, or chronic medical or psychiatric condition or laboratory abnormality
  • Has any immunological disease, which is not adequately controlled, or which requires treatment with biologics and/or immunosuppressants during the study
  • Has a bleeding disorder that is not under adequate control
  • Has a history of malignancy occurring within 5 years of screening
  • Has a risk factor for corrected QT interval (QTc) prolongation
  • Has liver disease
  • Is unwilling or unable to undergo computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) scan
  • Resides in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision

Trial locations and contacts

80 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

80 sites in 11 countries

United States36 sites, 35 recruiting

  • Alzheimer Disease Research Center (ADRC) ( Site 1000)

    Albany, New York, 12208

    Study Coordinator, 518-426-0575

    Recruiting

  • JEM Research Institute ( Site 1046)

    Atlantis, Florida, 33462

    Study Coordinator, 561-968-2933

    Recruiting

  • Gadolin Research ( Site 1032)

    Beaumont, Texas, 77702

    Study Coordinator, 409-331-6040

    Recruiting

  • Clinical Research Professionals ( Site 1004)

    Chesterfield, Missouri, 63005

    Completed

  • Horizon Clinical Research Center - Houston ( Site 1026)

    Cypress, Texas, 77429

    Study Coordinator, 949-491-0710

    Recruiting

  • CenExel iResearch, LLC ( Site 1015)

    Decatur, Georgia, 30030

    Study Coordinator, 404-537-1281

    Recruiting

  • Alexian Brothers Medical Center-Neurosciences ( Site 1017)

    Elk Grove Village, Illinois, 60007

    Study Coordinator, 847-593-8553

    Recruiting

  • Neuropsychiatric Research Center of Southwest Florida ( Site 1003)

    Fort Myers, Florida, 33912

    Study Coordinator, 239-939-7777

    Recruiting

  • Insight Clinical Trials ( Site 1011)

    Independence, Ohio, 44131

    Study Coordinator, 216-245-6556

    Recruiting

  • Irvine Clinical Research ( Site 1041)

    Irvine, California, 92614

    Study Coordinator, 949-753-1663

    Recruiting

  • Healthy Brain Clinic ( Site 1005)

    Long Beach, California, 90804

    Study Coordinator, 562-606-5999

    Recruiting

  • Inglewood Clinical ( Site 1062)

    Los Angeles, California, 90056

    Study Coordinator, 949-265-1612

    Recruiting

  • K2 Medical Research ( Site 1047)

    Maitland, Florida, 32750

    Study Coordinator, 407-500-5252

    Recruiting

  • CenExel- AMRI ( Site 1018)

    Marlton, New Jersey, 08053

    Study Coordinator, 732-341-9500

    Recruiting

  • AMC Research, LLC ( Site 1006)

    Matthews, North Carolina, 28105

    Study Coordinator, 704-364-4000

    Recruiting

  • ClinCloud LLC ( Site 1039)

    Melbourne, Florida, 32940

    Study Coordinator, 407-680-0534

    Recruiting

  • Indago Research and Health Center Inc ( Site 1044)

    Miami Lakes, Florida, 33016

    Study Coordinator, 305-825-6588

    Recruiting

  • Aqualane Clinical Research ( Site 1035)

    Naples, Florida, 34105

    Study Coordinator, 239-529-6780

    Recruiting

  • Yale University, Alzheimer's Disease Research Unit ( Site 1059)

    New Haven, Connecticut, 06510

    Study Coordinator, 203-764-8100

    Recruiting

  • Suncoast Clinical Research ( Site 1007)

    New Port Richey, Florida, 34652

    Study Coordinator, 727-849-4131

    Recruiting

  • Mid Hudson Medical Research ( Site 1050)

    New Windsor, New York, 12553

    Study Coordinator, 845-674-9398

    Recruiting

  • Boston Center for Memory ( Site 1008)

    Newton, Massachusetts, 02459

    Study Coordinator, 617-699-6927

    Recruiting

  • Neuro-Behavioral Clinical Research ( Site 1028)

    North Canton, Ohio, 44720

    Study Coordinator, 330-493-1118

    Recruiting

  • Renstar Medical Research ( Site 1012)

    Ocala, Florida, 34471

    Study Coordinator, 352-629-5800

    Recruiting

  • Charter Research - Orlando ( Site 1051)

    Orlando, Florida, 32803

    Study Coordinator, 407-337-3000

    Recruiting

  • Flourish Research ( Site 1048)

    Plymouth Meeting, Pennsylvania, 19462

    Study Coordinator, 610-277-8073

    Recruiting

  • Basil Clinical ( Site 1065)

    Queens, New York, 11413

    Study Coordinator, 917-672-3275

    Recruiting

  • Anderson Clinical Research ( Site 1024)

    Redlands, California, 92374

    Study Coordinator, 909-792-9007

    Recruiting

  • The Cognitive and Research Center of New Jersey - Ridgewood ( Site 1064)

    Ridgewood, New Jersey, 07450

    Study Coordinator, 201-850-4622

    Recruiting

  • UCSF Memory and Aging Center ( Site 1031)

    San Francisco, California, 94158

    Study Coordinator, 415-353-3585

    Recruiting

  • Syrentis Clinical Research ( Site 1001)

    Santa Ana, California, 92705

    Study Coordinator, 714-542-3008

    Recruiting

  • The Cognitive and Research Center of NJ ( Site 1057)

    Springfield, New Jersey, 07081

    Study Coordinator, 973-850-4622

    Recruiting

  • Axiom Brain Health ( Site 1029)

    Tampa, Florida, 33609

    Study Coordinator, 813-353-9613

    Recruiting

  • K2 Medical Research ( Site 1020)

    Tampa, Florida, 33634

    Study Coordinator, 813-800-5252

    Recruiting

  • Charter Research - Lady Lake ( Site 1019)

    The Villages, Florida, 32162

    Study Coordinator, 352-775-1000

    Recruiting

  • Conquest Research LLC ( Site 1053)

    Winter Park, Florida, 32789

    Study Coordinator, 407-916-0060

    Recruiting

Other trials in United States

Japan11 sites, 11 recruiting

  • Inage Neurology and Memory Clinic ( Site 9001)

    Chiba, 263-0043

    Study Coordinator, +81-43-307-8500

    Recruiting

  • Kyushu University Hospital ( Site 9010)

    Fukuoka, 812-8582

    Study Coordinator, +81-92-642-5774

    Recruiting

  • Hatsuta Neurology Clinic ( Site 9017)

    Hirakata, Osaka, 573-1121

    Study Coordinator, +81-72-850-8692

    Recruiting

  • National Hospital Organization Hizen Psychiatric Medical Center ( Site 9004)

    Kanzaki-gun, Saga-ken, 8420192

    Study Coordinator, +81-952-52-3231

    Recruiting

  • Association of Healthcare Corporation Koukankai Koukan Clinic ( Site 9016)

    Kawasaki, Kanagawa, 210-0852

    Study Coordinator, +81-44-366-8900

    Recruiting

  • Katayama Medical Clinic ( Site 9005)

    Kurashiki, Okayama-ken, 710-0813

    Study Coordinator, +81-86-422-0753

    Recruiting

  • Chibaken Saiseikai Narashino Hospital ( Site 9000)

    Narashino, Chiba, 275-8580

    Study Coordinator, +81-47-473-1281

    Recruiting

  • National Center for Geriatrics and Gerontology ( Site 9002)

    Ōbu, Aichi-ken, 474-8511

    Study Coordinator, +81-562-46-2311

    Recruiting

  • Okayama City General Medical Center Okayama City Hospital ( Site 9008)

    Okayama, 700-8557

    Study Coordinator, +81-86-737-3000

    Recruiting

  • Tokyo Medical University Hospital ( Site 9003)

    Shinjuku, Tokyo, 160-0023

    Study Coordinator, +81-3-3342-6111

    Recruiting

  • Mie University Hospital ( Site 9011)

    Tsu, Mie-ken, 514-8507

    Study Coordinator, +81-59-231-5246

    Recruiting

Other trials in Japan

United Kingdom7 sites, 7 recruiting

  • Scottish Brain Sciences Aberdeen ( Site 8001)

    Aberdeen, Aberdeen City, AB25 2XE

    Study Coordinator, +4401313530233

    Recruiting

  • Remind UK ( Site 8003)

    Bath, Somerset, BA1 3NG

    Study Coordinator, 01225 476420

    Recruiting

  • Re:Cognition Health - Birmingham ( Site 8002)

    Birmingham, B16 8LT

    Study Coordinator, 0121 655 016

    Recruiting

  • Scottish Brain Sciences ( Site 8000)

    Edinburgh, Edinburgh, City of, EH12 5PJ

    Study Coordinator, +4401313530233

    Recruiting

  • Leonard Wolfson Experimental Neurology Centre (LWENC) ( Site 8006)

    London, London, City of, NW1 2PG

    Study Coordinator, 020 3448 4531

    Recruiting

  • Warneford Hospital ( Site 8007)

    Oxford, Oxfordshire, OX3 7JX

    Study Coordinator, +441865902135

    Recruiting

  • Moorgreen Hospital ( Site 8004)

    Southampton, Hampshire, SO30 3JB

    Study Coordinator, +44 (0) 2382318757

    Recruiting

Other trials in United Kingdom

Australia4 sites, 4 recruiting

  • Austin Health ( Site 0300)

    Ivanhoe, Victoria, 3079

    Study Coordinator, 61394962181

    Recruiting

  • Southern Neurology ( Site 0306)

    Kogarah, New South Wales, 2217

    Study Coordinator, +61408455183

    Recruiting

  • KARA Institute for Neurological Diseases ( Site 0302)

    Macquarie Park, New South Wales, 2113

    Study Coordinator, +61289607788

    Recruiting

  • HammondCare ( Site 0301)

    Malvern, Victoria, 3144

    Study Coordinator, +61395976568

    Recruiting

Other trials in Australia

Canada4 sites, 4 recruiting

  • Clinique Mémoire de Montreal ( Site 2000)

    Montreal, Quebec, H3G 1H9

    Study Coordinator, 5144003903

    Recruiting

  • Ottawa Memory Clinic ( Site 2001)

    Ottawa, Ontario, K1Z 1G3

    Study Coordinator, 613-702-1000

    Recruiting

  • Sunnybrook Research Institute ( Site 2003)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 4164804551

    Recruiting

  • Toronto Western Hospital ( Site 2004)

    Toronto, Ontario, M5T 2S8

    Study Coordinator, 4166032581

    Recruiting

Other trials in Canada

Spain4 sites, 4 recruiting

  • Fundació ACE ( Site 6003)

    Barcelona, Catalonia, 08028

    Study Coordinator, +34677440680

    Recruiting

  • Hospital del Mar ( Site 6001)

    Barcelona, 08003

    Study Coordinator, +34933160778

    Recruiting

  • Hospital Clinic i Provincial ( Site 6002)

    Barcelona, 08036

    Study Coordinator, +34626001165

    Recruiting

  • Hospital Universitari Mutua Terrassa ( Site 6004)

    Terrassa, Barcelona, 08222

    Study Coordinator, +34937365050

    Recruiting

Other trials in Spain

Argentina3 sites, 3 recruiting

  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) ( Site 0400)

    Caba, C1428AQK

    Study Coordinator, +541157773200

    Recruiting

  • Organizacion Medica de Investigacion ( Site 0401)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1015ABO

    Study Coordinator, +5491143720308

    Recruiting

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0404)

    Ciudad de Buenos Aires, Buenos Aires F.D., C1431FWO

    Study Coordinator, +5401152990000

    Recruiting

Other trials in Argentina

Belgium3 sites, 3 recruiting

  • Cliniques universitaires Saint-Luc ( Site 3001)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, +3227641779

    Recruiting

  • AZ Groeninge Campus Kennedylaan ( Site 3002)

    Kortrijk, West-Vlaanderen, 8500

    Study Coordinator, +3256636363

    Recruiting

  • UZ Leuven ( Site 3000)

    Leuven, Vlaams-Brabant, 3000

    Study Coordinator, +32 16 34 75 90

    Recruiting

Other trials in Belgium

Netherlands3 sites, 3 recruiting

  • Brain Research Center Den Bosch B.V. ( Site 5001)

    's-Hertogenbosch, North Brabant, 5223 LA

    Study Coordinator, +0203017170

    Recruiting

  • Brain Research Center. ( Site 5000)

    Amsterdam, North Holland, 1081 GN

    Study Coordinator, +0203017170

    Recruiting

  • Brain Research Center Zwolle ( Site 5002)

    Zwolle, Overijssel, 8025 AZ

    Study Coordinator, +0203017170

    Recruiting

Other trials in Netherlands

South Korea3 sites, 3 recruiting

  • Hanyang University Hospital ( Site 0200)

    Seoul, 04763

    Study Coordinator, +82222908374

    Recruiting

  • Samsung Medical Center ( Site 0202)

    Seoul, 06351

    Study Coordinator, +82234101233

    Recruiting

  • Ewha Womans University Seoul Hospital ( Site 0201)

    Seoul, 07804

    Study Coordinator, +82269861792

    Recruiting

Other trials in South Korea

Singapore2 sites, 2 recruiting

  • National Neuroscience Institute ( Site 0101)

    Singapore, Central Singapore, 308433

    Study Coordinator, '+6563306363

    Recruiting

  • Tan Tock Seng Hospital ( Site 0102)

    Singapore, Central Singapore, 308433

    Study Coordinator, +6562566011

    Recruiting

Other trials in Singapore

About this study

Official title: A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants With Early Alzheimer's Disease

Researchers want to know if the study treatment called MK-2214 works to slow certain changes in the brains of people with Alzheimer's disease (AD). AD is a type of dementia that can cause loss of memory, communication (such as speech), and decision-making skills. It can limit a person's ability to do daily tasks. MK-2214 is a study treatment designed to slow down AD.

The goals of the study are to learn:

  • If MK-2214 slows the spread of tau in the brain compared to placebo. Tau is a protein that accumulates in AD \& damages brain cells. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of a study treatment.
  • About the safety of MK-2214 and if people tolerate it
Read the detailed description

Per AM03, an optional open-label extension period has been added to the study.

Being tested
MK-2214, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-2214Biological

    IV infusion

  • PlaceboDrug

    IV infusion

Study groups in NCT07033494
Study groupRoleWhat they receive
Base and Open-Label Extension Period: MK-2214ExperimentalParticipants will receive MK-2214 via intravenous (IV) infusion every 4 weeks (q4w) during the base period. After the completion of the base period participants have the option to continue receiving MK-2214 throughout the open-label extension period.
Receives: Biological: MK-2214
Base Period: PlaceboPlacebo comparatorParticipants will receive a placebo via IV infusion q4w during the base period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Base Period: Change from Baseline in Tau PET Standardized Uptake Value Ratio (SUVr)

    Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD \& damages brain cells. SUVr is SUV in the region of interest divided by SUV in a reference region (cerebellum). The change from baseline in tau PET SUVr will be reported.

    Measured: Baseline, up to approximately 23 months

  2. Base Period: Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience one or more AEs will be reported.

    Measured: Up to approximately 26 months

  3. Base Period: Number of Participants Who Discontinue Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study intervention due to an AE will be reported.

    Measured: Up to approximately 23 months

Secondary outcomes (7)

  1. Base Period: Change from Baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) Total Score

    The CDR-SB is used for cognitive assessment in people with AD. The CDR is a clinical scale that describes 5 degrees of impairment in performance on each of 6 categories of function including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The ratings of degree of impairment obtained on each of the 6 categories of function are synthesized into 1 global rating of dementia CDR score ranging from 0 (normal) to 3 (severe). A total score is calculated as the sum of the category scores, with a range of 0 (normal) to 18 (severe). Higher scores indicate more impairment. The change from baseline in CDR-SB total score will be reported.

    Measured: Baseline, up to approximately 23 months

  2. Base Period: Change from Baseline in the Composite Tau PET SUVr in Braak Region III and IV

    Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD \& damages brain cells. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). Braak staging ranges from Braak I to VI. Description for Braak III includes amygdala, parahippocampal gyrus, fusiform gyrus, \& lingual gyrus, and Braak IV includes insula, inferior temporal, lateral temporal, posterior cingulate, \& inferior parietal. The composite tau PET SUVr is a weighted average of tau PET SUVr values obtained from multiple brain regions, with weights being the percentage volume of each region within the composite. The change from baseline in composite tau PET SUVr in Braak regions III and IV will be reported.

    Measured: Baseline, up to approximately 23 months

  3. Base Period: Change from Baseline in the Composite Tau PET SUVr

    Participants will have tau PET imaging to assess tau pathology. Tau is a protein that accumulates in AD \& damages brain cells. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). The composite tau PET SUVr is a weighted average of tau PET SUVr values obtained from multiple brain regions, with weights being the percentage volume of each region within the composite. The change from baseline in composite tau PET SUVr will be reported.

    Measured: Baseline, up to approximately 23 months

  4. Base Period: Change from Baseline in the Composite Tau PET SUVr in Braak Region I to VI

    Participants will have tau PET imaging to assess tau (protein that accumulates in AD \& damages brain cells) pathology. SUVr is SUV in the region of interest, divided by SUV in a reference region (cerebellum). Braak staging ranges from I-VI (Braak I (transentorhinal); II (entorhinal \& hippocampus); III (amygdala, parahippocampal gyrus, fusiform gyrus, \& lingual gyrus); IV (insula, inferior temporal, lateral temporal, posterior cingulate, \& inferior parietal); V (orbitofrontal, superior temporal, inferior frontal, cuneus, anterior cingulate, supramarginal gyrus, lateral occipital, precuneus, superior parietal, superior frontal, \& rostro medial frontal); VI (paracentral, postcentral, precentral, \& pericalcarine)). Composite tau PET SUVr is weighted average of tau PET SUVr values from multiple brain regions, with weights being percentage volume of each region. The change from baseline in composite tau PET SUVr in Braak region I to IV will be reported.

    Measured: Baseline, up to approximately 23 months

  5. Base Period: Change from Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale13 (ADAS-Cog13) Total Score

    The ADAS-Cog13 is a structured scale that evaluates memory (word recall, delayed word recall, and word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). In addition, ratings of spoken language, language comprehension, word finding difficulty, ability to remember test instructions, and number cancellation will be obtained. Per protocol, score range will be from 0 (no impairment) to 85 (maximum impairment) points. Higher scores indicate more impairment. The change from baseline in ADAS-Cog13 total score will be reported.

    Measured: Baseline, up to approximately 23 months

  6. Base Period: Change from Baseline in the Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS-ADL-MCI) Total Score

    ADCS-ADL-MCI evaluates the ability of individuals to perform various daily activities including basic activities of daily living (BADL; personal care tasks like bathing, dressing and eating) and instrumental activities of daily living (IADL; complex tasks such as managing finances, preparing meals, using telephone) administered through caregiver or family member to access severity of cognitive decline in the past 4 weeks. Each item is scored on a scale of 0 (unable to do) to 2 (independent). The total score is calculated by summing scores of all items and ranges from 0 (poor functioning) to 68 (better functioning). Higher scores indicate better functional ability. The change from baseline in ADCS-ADL-MCI total score will be reported.

    Measured: Baseline, up to approximately 23 months

  7. Base Period: Change from Baseline in Modified Integrated Alzheimer's Disease Rating Scale (iADRS) Total Score

    The modified iADRS is a composite tool to measure cognition and function. The modified iADRS is a linear combination of total scores from the ADAS-Cog and the ADCS-ADL-MCI. The modified iADRS composite score is calculated by subtracting the ADAS-Cog13 score from 85 and then adding the ADCS-ADL-MCI score. Composite score ranges from 0 (maximum impairment) to 144 (greater independent, healthy functioning and cognition). Lower scores indicate more impairment. The change from baseline in modified iADRS total score will be reported.

    Measured: Baseline, up to approximately 23 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start16 Jul 2025
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There are two parts of the study. The blinded period is randomized parallel treatment groups. Participants who complete the blinded period are then eligible to enroll in an open label extension (OLE) (single group).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07033494
Sponsor's protocol ID
2214-004
Other IDs
MK-2214-004, 2024-519190-19-00, U1111-1314-8296, jRCT2031250299
Status last verified
Oct 2026
First submitted
13 Jun 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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