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Follicular LymphomaPhase 2/3NCT07634471

A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)

A Phase 2/3 study testing MK-1045, Rituximab and Rituximab biosimilar in people with Follicular Lymphoma, run by Merck Sharp & Dohme LLC at 35 sites in 13 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
MK-1045, Rituximab and Rituximab biosimilar
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
960 participants
Where
35 sitesin 13 countries
Study dates
22 Jun 2026to 23 Jul 2035
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.
  • Has radiographically measurable disease per the Lugano Response Criteria.
  • Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.
  • If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).
  • If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
  • If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.

Who cannot join

  • Has received prior systemic anticancer therapy or radiotherapy for FL.
  • Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.
  • Has FL that has transformed into a more aggressive type of lymphoma.
  • History or presence of clinically relevant central nervous system (CNS) diseases.
  • Has history of serious cardiovascular and cerebrovascular diseases.
  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Show all 14Show fewer
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has known active CNS lymphoma or involvement.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has active infection requiring systemic therapy.
  • Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.
  • Has not adequately recovered from major surgery or has ongoing surgical complications.

Trial locations and contacts

35 sites in 13 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

35 sites in 13 countries

United States7 sites, 7 recruiting

  • University Hospitals of Cleveland ( Site 1321)

    Cleveland, Ohio, 44106

    Study Coordinator, 216-425-6880

    Recruiting

  • City of Hope - Duarte Cancer Center ( Site 1301)

    Duarte, California, 91010

    Study Coordinator, 877-589-4352

    Recruiting

  • Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307)

    Durham, North Carolina, 27710

    Study Coordinator, 919-681-5698

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1311)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-1777

    Recruiting

  • University of Kentucky ( Site 1303)

    Lexington, Kentucky, 40536

    Study Coordinator, 859-323-2354

    Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-329-7640

    Recruiting

  • Icahn School of Medicine at Mount Sinai ( Site 1325)

    New York, New York, 10029

    Study Coordinator, 212-824-7391

    Recruiting

Other trials in United States

Spain5 sites, 5 recruiting

  • Institut Català d'Oncologia (ICO) - Badalona ( Site 0904)

    Badalona, Barcelona, 08916

    Study Coordinator, 34 934978387

    Recruiting

  • Hospital Universitari Vall de Hebron ( Site 0903)

    Barcelona, 08035

    Study Coordinator, +34932746000, 2347

    Recruiting

  • Hospital Universitario Gregorio Maranon ( Site 0902)

    Madrid, 28007

    Study Coordinator, 34 915868888

    Recruiting

  • Hospital Virgen de la Victoria ( Site 0905)

    Málaga, Malaga, 29010

    Study Coordinator, 34 923291100,56621

    Recruiting

  • Hospital Universitario de Salamanca ( Site 0906)

    Salamanca, 37007

    Study Coordinator, +34923291100ext56621

    Recruiting

Other trials in Spain

Argentina4 sites, 4 recruiting

  • Hospital Aleman ( Site 0101)

    Buenos Aires, Buenos Aires F.D., C1118AAT

    Study Coordinator, +54 11-4827-7000

    Recruiting

  • Instituto Alexander Fleming ( Site 0105)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Hospital Privado Universitario de Córdoba ( Site 0102)

    Córdoba, X5016KEH

    Study Coordinator, +54 9 0351 468-8200

    Recruiting

  • Sanatorio Nuestra Senora del Rosario ( Site 0104)

    Rosario, Santa Fe Province, S2001SBK

    Study Coordinator, +543414858585

    Recruiting

Other trials in Argentina

Israel3 sites, 3 recruiting

  • Hadassah Medical Center ( Site 0701)

    Jerusalem, 9112001

    Study Coordinator, +97226777333

    Recruiting

  • Sheba Medical Center ( Site 0702)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

  • Sourasky Medical Center ( Site 0704)

    Tel Aviv, 6423906

    Study Coordinator, +97236974444

    Recruiting

Other trials in Israel

Turkey (Türkiye)3 sites, 3 recruiting

  • Hacettepe Universite Hastaneleri ( Site 1110)

    Ankara, 06230

    Study Coordinator, +905348719633

    Recruiting

  • Sisli Florence Nightingale Hastanesi ( Site 1112)

    Istanbul, 34381

    Study Coordinator, +905348310606

    Recruiting

  • Ondokuz Mayıs Universitesi ( Site 1113)

    Samsun, 55270

    Study Coordinator, +905068756912

    Recruiting

Other trials in Turkey (Türkiye)

Chile2 sites, 2 recruiting

  • Biocenter ( Site 0402)

    Concepción, Biobio, 4070196

    Study Coordinator, +5695684078

    Recruiting

  • Fundacion Arturo Lopez Perez FALP ( Site 0404)

    Santiago, Region M. de Santiago, 7500836

    Study Coordinator, +56224205098

    Recruiting

Other trials in Chile

China2 sites, 2 recruiting

  • Beijing Cancer hospital ( Site 0501)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, +861088196118

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 0504)

    Shanghai, Shanghai Municipality, 200030

    Study Coordinator, +860216417559088217

    Recruiting

Other trials in China

Greece2 sites, 2 recruiting

  • Evangelismos General Hospital of Athens ( Site 1501)

    Athens, Attica, 106 76

    Study Coordinator, 00302132041

    Recruiting

  • General Hospital of Athens "Laiko" ( Site 1502)

    Athens, Attica, 115 27

    Study Coordinator, +302132061702

    Recruiting

Other trials in Greece

Poland2 sites, 2 recruiting

  • Pratia MCM Krakow ( Site 1702)

    Krakow, Lesser Poland Voivodeship, 30-727

    Study Coordinator, +48122958160

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1701)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225462000

    Recruiting

Other trials in Poland

Taiwan2 sites, 2 recruiting

  • National Taiwan University Hospital ( Site 1001)

    Taipei, 100225

    Study Coordinator, 02-23123456

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 1002)

    Taoyuan, 333

    Study Coordinator, 03-3281200

    Recruiting

Other trials in Taiwan

Australia1 site, 1 recruiting

  • Box Hill Hospital ( Site 0201)

    Box Hill, Victoria, 3128

    Study Coordinator, +6104438659719

    Recruiting

Other trials in Australia

Italy1 site, 1 recruiting

  • INOC - Istituto Nazionale Oncologico Candiolo ( Site 1602)

    Candiolo, Torino, 10060

    Study Coordinator, +390119933355

    Recruiting

Other trials in Italy

South Korea1 site, 1 recruiting

  • Samsung Medical Center ( Site 0801)

    Seoul, 06351

    Study Coordinator, +82234106548

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma

Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.

The goals of this study are to learn:

  • About the safety of MK-1045 and rituximab, and if people tolerate them when given together
  • If people who receive MK-1045 and rituximab have the cancer go away
  • If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)
Being tested
MK-1045, Rituximab, Rituximab biosimilar, Bendamustine, Cyclophosphamide
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • MK-1045Biological

    Also called CN201

    Intravenous (IV) infusion

  • RituximabBiological

    IV infusion

  • Rituximab biosimilarBiological

    Also called TRUXIMA®, RUXIENCE®, RIABNI®

    IV infusion

  • BendamustineDrug

    Also called Bendeka, Treanda, Belrapzo

    IV infusion

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar, Cytophosphane

    IV infusion

  • VincristineDrug

    Also called Oncovin, Vincasar PFS

    IV infusion

  • PrednisoneDrug

    Also called Prednisone acetate

    Per approved product label

  • PrednisoloneDrug

    Also called Prednisolone acetate

    Per approved product label

  • Doxorubicin HydrochlorideDrug

    Also called Adriamycin

    IV infusion

Study groups in NCT07634471
Study groupRoleWhat they receive
Part 1: MK-1045 plus Rituximab (or biosimilar)ExperimentalParticipants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.
Receives: Biological: MK-1045; Biological: Rituximab; Biological: Rituximab biosimilar
Part 2: MK-1045 plus Rituximab (or biosimilar)ExperimentalParticipants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.
Receives: Biological: MK-1045; Biological: Rituximab; Biological: Rituximab biosimilar
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)ExperimentalParticipants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
Receives: Biological: Rituximab; Biological: Rituximab biosimilar; Drug: Bendamustine; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Prednisone; Drug: Prednisolone; Drug: Doxorubicin Hydrochloride

What is being measured

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

  1. Part 1: Number of Participants Who Experience an Adverse Event (AE)

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 15 months

  2. Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 12 months

  3. Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)

    DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.

    Measured: Up to approximately 36 days

  4. Part 1: Complete Response (CR) Rate

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented.

    Measured: Up to approximately 60 months

  5. Part 2: Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 63 months

Secondary outcomes (15)

  1. Part 1: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by physician investigator will be presented.

    Measured: Up to approximately 60 months

  2. Part 1: Duration of CR

    For participants who demonstrate CR (CR: disappearance of all target lesions) at end of treatment per Lugano response criteria, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 60 months

  3. Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045

    Blood samples will be collected at multiple time points to estimate the AUCss of MK-1045.

    Measured: Predose and at designated time points post-dose (up to approximately 12 months)

  4. Part 1: Maximum Concentration (Cmax) of MK-1045

    Blood samples will be collected at multiple time points to estimate the Cmax of MK-1045.

    Measured: Predose and at designated time points post-dose (up to approximately 12 months)

  5. Part 1: Trough Concentration (Ctrough) of MK-1045

    Blood samples will be collected at multiple time points to estimate the Ctrough of MK-1045.

    Measured: Predose and at designated time points post-dose (up to approximately 12 months)

  6. Part 2: CR Rate at 30 Months

    For participants who demonstrate a confirmed CR (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR by month 30. The CR rate as assessed by BICR at month 30 will be presented.

    Measured: 30 months

  7. Part 2: ORR

    ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or PR (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 63 months

  8. Part 2: Overall Survival (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 63 months

  9. Part 2: Event-Free Survival (EFS)

    EFS is defined as the time randomization to the first documented disease progression per Lugano response criteria by BICR, death due to any cause, initiation of a new anticancer therapy or a positive biopsy for residual disease, whichever occurs first.

    Measured: Up to approximately 63 months

  10. Part 2: Duration of CR

    For participants who demonstrate CR (CR: disappearance of all target lesions) per Lugano response criteria by BICR, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 63 months

  11. Part 2: Number of Participants Who Experience an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 15 months

  12. Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

    Measured: Up to approximately 12 months

  13. Part 2: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index (TOI)

    The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.

    Measured: Baseline and up to approximately month 13

  14. Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score

    The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.

    Measured: Baseline and up to approximately month 13

  15. Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7)

    The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life.

    Measured: Baseline and up to approximately month 13

Timeline

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

  1. First posted8 Jun 2026
  2. Study start22 Jun 2026
  3. Primary completion23 Jul 2032 (estimated)
  4. Study completion23 Jul 2035 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07634471
Sponsor's protocol ID
1045-007
Other IDs
U1111-1324-3019, 2025-522777-10-00, MK-1045-007, 2025
Status last verified
Oct 2026
First submitted
4 Jun 2026
Last updated
26 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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MK-1045, Rituximab and Rituximab biosimilar in people with Follicular Lymphoma, run by Merck Sharp & Dohme LLC at 35 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Spain, Argentina, Israel, Turkey (Türkiye) and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 15 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07634471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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