A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the Body (NCT06421636)
A PHASE 2, TWO-PART, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SUBCUTANEOUSLY ADMINISTERED REGN7999 (AN INHIBITOR OF TMPRSS6) IN PARTICIPANTS WITH IRON OVERLOAD DUE TO NON-TRANSFUSION DEPENDENT β-THALASSEMIA
🩺 Plain-English Summary (8th-Grade Level)
This study is researching an experimental drug called REGN7999 (called "study drug"). The study is focused on patients with non-transfusion dependent beta-thalassemia. The aim of the study is to see how safe and effective the study drug is. The study is looking at several other research questions, including: * Whether the study drug lowers extra iron levels in the body * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Who can join: Review the eligibility criteria below.
Location: Weill Cornell Medicine — New York, New York
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- Weill Cornell Medicine — New York, New York
- K Eristavi National Center of Experimental and Clinical Surgery — Tbilisi,
- Medinvest Institute of Hematology and Transfusiology Limited — Tbilisi,
- Children's Hospital Agia Sophia — Athens, Attica
- Laiko General Hospital of Athens — Athens, Attica
- University Hospital of Ioannina — Ioannina,
- Hemato-Oncology Clinic Ahmedabad PVT. LTD. — Ahmedabad, Gujarat
- Nirmal Hospital Pvt. Ltd - Surat — Surat, Gujarat
- Amrita Institute of Medical Sciences and Research Centre (AIMS) — Kochi, Kerala
- K J Somaiya Super Specialty Hospital & Research Centre — Mumbai, Maharashtra
- All India Institute of Medical Sciences, New Delhi — New Delhi, National Capital Territory of Delhi
- Indraprastha Apollo Hospitals — New Delhi, National Capital Territory of Delhi
- JK Lon Hospital — Jaipur, Rajasthan
- Day Hospital Thalassemia and Haemoglobinopathies (DHTE); A.O.U S.Anna — Ferrara,
- Hospital Queen Elizabeth — Kota Kinabalu, Sabah
- Sarawak General Hospital — Kuching, Sarawak
- Hospital Ampang — Ampang, Selangor
- Hospital Tunku Ampuan Besar Tuanku Aishah Rohani (HPKK UKM) — Kuala Lumpur,
- Songklanagarind Hospital, Prince of Songkla University — Hat Yai, Changwat Songkhla
- Chulalongkorn University — Bangkok,
- Phramongkutklao Hospital — Bangkok,
- Chiang Mai University — Chiang Mai,
- Srinagarind Hospital — Khon Kaen,
- Hacettepe University — Ankara,
- University College London Hospitals NHS Trust — London,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Non-Transfusion Dependent Beta-Thalassemia (NTDT) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.