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ObesityPhase 3AMAZE 8NCT07400107

AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

A Phase 3 study testing NNC0487-0111 and Semaglutide in people with Obesity and Overweight, run by Novo Nordisk A/S at 120 sites in 14 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight, Diabetes Mellitus, Type 2
What is being tested?
NNC0487-0111 and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
120 sitesin 14 countries
Study dates
20 May 2026to 26 Jan 2029
Phase
Phase 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

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
  • Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at screening.
  • Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening.

Who cannot join

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 milliliter (mL)/ minute (min)/1.73 meter squared (m^2) (2021 Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula), at screening.
  • Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
  • Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.

Trial locations and contacts

120 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

120 sites in 14 countries

Poland20 sites

  • Legeartis Poradnie Specjalistyczne Sp. z o.o.

    Bialystok, Podlaskie Voivodeship, 15-404

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, 15-435

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, 15-879

  • Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.

    Elblag, 82-300

  • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

    Gorzów Wielkopolski, 66-400

  • Przychodnie Grudziadz Sp. z o. o.

    Grudziądz, Mazovian Voivodeship, 86-300

  • SP ZOZ w Kalwarii Zebrzydowskiej

    Kalwaria Zebrzydowska, 34-130

  • Linden sp. z o.o. sp. k.

    Krakow, 30-105

  • Diamond Clinic sp zoo

    Krakow, 31-559

  • Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.

    Legnica, 59-220

  • Serce Sp. z o.o.

    Leszno, 64-100

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132

  • Centrum Terapii Wspolczesnej - J.M. Jasnorzewska S.K.A.

    Lodz, 90-338

  • Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna

    Lublin, Lesser Poland Voivodeship, 20-064

  • EKAMED sp. z o.o.

    Lublin, Lublin Voivodeship, 20-718

  • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.

    Ruda Śląska, 41-709

  • Lukmed 2 Sp. z o.o.

    Siedlce, 08-110

  • Szpital Czerniakowski Sp. z o.o.

    Warsaw, 00-739

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

    Zabrze, 41-800

  • Prywatna Praktyka Lekarska Anna Chudoba

    Żyrardów, 96-300

Other trials in Poland

India18 sites

  • Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University

    Aligarh, 202002

  • Diacon Hospital Private Limited

    Bangalore, Karnataka, 560010

  • Lifecare Hospital and Research Centre

    Bengaluru, Karnataka, 560066

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001

  • NIZAM'S Institute of Medical Sciences

    Hyderabad, Telangana, 500082

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh, 452010

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • IPGME&R and SSKM Hospital

    Kolkata, West Bengal, 700020

  • Arthur Asirvatham hospital,

    Madurai, Tamil Nadu, 625 020

  • BSES MG hospital

    Mumbai, Maharashtra, 400058

  • Shalini Tai Meghe Hospital and Research Center

    Nagpur, Maharashtra, 441110

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, 110029

  • Chellaram Diabetes Institute

    Pune, Maharashtra, 411021

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002

  • Jothydev's Diabetes & Research Center

    Thriruvananthapuram, 695 032

  • SSG Hospital, Baroda

    Vadodara, Gujarat, 390001

Other trials in India

Bulgaria11 sites

  • Dr. Tatyana Metalova - AIPSMCE EOOD

    Gotse Delchev, 2900

  • Medical centre Zdrave 1 OOD

    Kozloduy, 3320

  • UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases

    Pazardzhik, 4400

  • MHAT Heart and Brain EAD - Pleven, Endocrinology and Metabolic Diseases

    Pleven, 5800

  • DCC I- Pleven EOOD Endocrinology

    Pleven, 5801

  • MHAT Knyaginya Klementina - Sofia EAD

    Sofia, 1233

  • MHAT Sveta Sofia EOOD, Department of Endocrinology and Metabolic diseases

    Sofia, 1404

  • Acibadem City Clinic UMHAT Tokuda EAD, Endocrinology

    Sofia, 1407

  • USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology

    Sofia, 1431

  • Medical Institute of Ministry of interior

    Sofia, 1606

  • Medical Centre - Clinic Nova EOOD

    Varna, 9000

Other trials in Bulgaria

United States10 sites

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Velocity Clin Res, Dallas

    Dallas, Texas, 75230

  • Encore Medical Research LLC

    Hollywood, Florida, 33024

  • Optimal Research Sites

    Orange City, Florida, 32763

  • Endo And Metab Cons

    Rockville, Maryland, 20852

  • Endocrine Research Solutions, Inc

    Roswell, Georgia, 30076

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Arcturus Healthcare, PLC.

    Troy, Michigan, 48098-6368

  • Encore Medical Research of Weston

    Weston, Florida, 33331

  • Selma Medical Associates

    Winchester, Virginia, 22601-3834

Other trials in United States

Germany10 sites

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545

  • Zentrum fuer klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04910

  • Praxis am Markt Dr. Becker

    Essen, 45355

  • MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien

    Fulda, 36037

  • Diabetes-Zentrum-Wilhelmsburg GbR

    Hamburg, 21109

  • Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz

    Lingen, 49808

  • SMO.MD GmbH - Zentrum für klinische Studien

    Magdeburg, 39120

  • Institut für Diabetesforschung Osnabrück

    Osnabrück, 49080

  • ceda - Centrum für Diabetologie und Allgemeinmedizin Pohlheim

    Pohlheim, 35415

  • Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann

    Witten, 58455

Other trials in Germany

Croatia8 sites

  • Poliklinika Medikol Zagreb

    Grad Zagreb, 10000

  • Opca bolnica Karlovac

    Karlovac, 47000

  • Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

    Krapinske Toplice, 49217

  • Poliklinika SLAVONIJA OSIJEK

    Osijek, 31000

  • Clinical Hospital Centre Rijeka_Endocrinology

    Rijeka, 51 000

  • General Hospital Dr. Josip Bencevic_Diabetic department

    Slavonski Brod, 35 000

  • Opca bolnica Varazdin_Endocrinology

    Varaždin, 42 000

  • Poliklinika Solmed

    Zagreb, 10000

Other trials in Croatia

Portugal8 sites

  • Hospital de Cascais

    Alcabideche, 2755-009

  • ULS Almada-Seixal E.P.E. - Hospital Garcia de Orta

    Almada, 2805-267

  • ULS De Braga, E.P.E. - Hospital de Braga

    Braga, 4710-243

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-189

  • Hosp. das Forças Armadas_ Endocrinologia

    Lisbon, 1649-020

  • ULS De São João, E.P.E. - Hospital de São João

    Porto, 4200-319

  • ULS De Matosinhos E.P.E.- Hospital Pedro Hispano

    Senhora Da Hora, Matosinhos, 4464-513

  • Hospital da Luz Arrabida, S.A.

    Vila Nova de Gaia, 4400-346

Other trials in Portugal

Romania8 sites

  • CMI Dr. Pletea Noemi SRL

    Bacau, 600154

  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

    Bucharest, Bucharest, 020475

  • SC Nutrilife SRL

    Bucharest, 013764

  • Diabet Med SRL

    Bucharest, 050913

  • Medical Practice SRL

    Oradea, 410001

  • Poli Cardinal Med Srl

    Reghin, Mureș County, 545300

  • Spital Judetean De Urgenta Satu Mare

    Satu Mare, 440055

  • Cabinet Medical Dr Geru SRL

    Timișoara, 300288

Other trials in Romania

Turkey (Türkiye)7 sites

  • Başkent Üniversitesi Adana-Endokrinoloji

    Adana /yüreği̇r, 01240

  • Ankara Bilkent Şehir Hastanesi-Dahiliye

    Ankara, 06800

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Endokrinoloji

    Battalgazi / Malatya, 44280

  • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

    Istanbul, 34722

  • Marmara Üniversitesi Pendik EAH- Endokrinoloji

    Pendik/istanbul, 34899

  • Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji

    Sivas, 58140

  • Adana Şehir Eğitim ve Araştırma Hastanesi-Endokrinoloji

    Yüreğir/Adana, 1370

Other trials in Turkey (Türkiye)

Hungary5 sites

  • Óbudai Egészségügyi Centrum

    Budapest, Pest County, 1036

  • Debreceni Egyetem

    Debrecen, Hajdú-Bihar, 4032

  • Békés Vármegyei Központi Kórház

    Gyula, 5700

  • Komáromi Selye János Kórház

    Komárom, Komárom-Esztergom, 2900

  • Borbánya Praxis E.Ü. Kft.

    Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405

Other trials in Hungary

Thailand5 sites

  • King Chulalongkorn Memorial Hospital_Endocrinology

    Bangkok, 10330

  • Rajavithi Hospital_Diabetes and Endocrinology

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Srinagarind Hospital

    Khon Kaen, 40002

Other trials in Thailand

Brazil4 sites

  • i9 Pesquisas Clínicas

    Campinas, São Paulo, 13092-133

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande do Sul, 90430-001

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

  • BR Trials - Ensaios Clínicos e Consultoria Ltda.

    São Paulo, São Paulo, 01236-030

Other trials in Brazil

Argentina3 sites

  • Centro de Investigaciones Metabólicas

    Capital Federal, Buenos Aires, C1056ABI

  • Centro Médico Privado San Vicente Diabetes

    Córdoba, X5006IKK

  • Centro Médico CIMEL

    Lanús Este, Buenos Aires, B1824KAJ

Other trials in Argentina

Mexico3 sites

  • Centro de Estudios de Investigación Metabólicos y Cardio

    Ciudad Madero, Tamaulipas, 89440

  • Diseño y Planeación en Investigación Médica S.C.

    Guadalajara, Jalisco, 44600

  • Alliance CEINV Salud S.A. de C.V.

    Monterrey, Nuevo León, 64020

Other trials in Mexico

About this study

Official title: Efficacy and Safety of NNC0487-0111 s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.

Being tested
NNC0487-0111, Semaglutide, Placebo (matched to NNC0487-0111), Placebo (matched to semaglutide)
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2

What participants receive

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

  • NNC0487-0111Drug

    NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • SemaglutideDrug

    Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • Placebo (matched to NNC0487-0111)Drug

    Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • Placebo (matched to semaglutide)Drug

    Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Study groups in NCT07400107
Study groupRoleWhat they receive
NNC0487-0111ExperimentalParticipants will receive NNC0487-0111 and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: NNC0487-0111; Drug: Placebo (matched to semaglutide)
SemaglutideActive comparatorParticipants will receive semaglutide and placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Receives: Drug: Semaglutide; Drug: Placebo (matched to NNC0487-0111)

What is being measured

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

  1. Relative change in body weight

    Measured as percentage of body weight.

    Measured: From baseline (week 0) to week 84

Secondary outcomes (24)

  1. Change in waist circumference

    Measured as centimeter (cm).

    Measured: From baseline (week 0) to week 84

  2. Change in systolic blood pressure (SBP)

    Measured as millimeter of mercury (mmHg).

    Measured: From baseline (week 0) to week 84

  3. Change in body weight

    Measured as kilograms (kg).

    Measured: From baseline (week 0) to week 84 and week 104

  4. Change in body mass index (BMI)

    Measured as kilograms per meter squared (kg/m^2).

    Measured: From baseline (week 0) to week 84 and week 104

  5. Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)

    Measured as count of participants.

    Measured: From baseline (week 0) to week 84

  6. Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)

    Measured as count of participants.

    Measured: From baseline (week 0) to week 84

  7. Number of participants with achievement of HbA1c < 5.7% (yes/no)

    Measured as count of participants.

    Measured: From baseline (week 0) to week 84

  8. Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)

    Measured as mmol/L.

    Measured: From baseline (week 0) to week 84

  9. Change in FPG measured as milligrams per deciliter (mg/dL)

    Measured as mg/dL.

    Measured: From baseline (week 0) to week 84

  10. Ratio to baseline: change in fasting insulin

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  11. Ratio to baseline: change in urinary albumin-to-creatinine ratio (UACR)

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  12. Change in diastolic blood pressure (DBP)

    Measured as mmHg.

    Measured: From baseline (week 0) to week 84

  13. Ratio to baseline: change in total cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  14. Ratio to baseline: change in high-density lipoprotein (HDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  15. Ratio to baseline: change in low-density lipoprotein (LDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  16. Ratio to baseline: change in very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  17. Ratio to baseline: change in non-HDL cholesterol

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  18. Ratio to baseline: change in triglycerides

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  19. Ratio to baseline: change in high-sensitivity C-reactive protein (hsCRP)

    Measured as ratio.

    Measured: From baseline (week 0) to week 84

  20. Number of Treatment Emergent Adverse Events (TEAEs)

    Measured as events.

    Measured: From baseline (week 0) to week 84 and week 109

  21. Number of Treatment Emergent Serious Adverse Events (TESAEs)

    Measured as events.

    Measured: From baseline (week 0) to week 84 and week 109

  22. Number of TEAEs leading to permanent treatment discontinuation

    Measured as events.

    Measured: From baseline (week 0) to week 84 and week 109

  23. Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 millimole per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by a blood glucose (BG) meter)

    Measured as episodes.

    Measured: From baseline (week 0) to week 84 and week 109

  24. Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Measured as episodes.

    Measured: From baseline (week 0) to week 84 and week 109

Timeline

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

  1. First posted10 Feb 2026
  2. Study start20 May 2026 (estimated)
  3. Primary completion12 Dec 2028 (estimated)
  4. Study completion26 Jan 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07400107
Sponsor's protocol ID
NN9490-8028
Other IDs
U1111-1313-8017, 2024-520446-31
Acronym
AMAZE 8
Status last verified
Mar 2026
First submitted
3 Feb 2026
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NNC0487-0111 and Semaglutide in people with Obesity and Overweight, run by Novo Nordisk A/S at 120 sites in 14 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in Poland, India, Bulgaria, United States, Germany and 9 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 phase mean?

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 Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in body weight (time frame: From baseline (week 0) to week 84). 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 NCT07400107.

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 12 Mar 2026.

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