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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 · View on ClinicalTrials.gov ↗
Study Summary
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)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG REGN7999
Study Locations (20)
Other
- K Eristavi National Center of Experimental and Clinical Surgery — Tbilisi
- Medinvest Institute of Hematology and Transfusiology Limited — Tbilisi
- University Hospital of Ioannina — Ioannina
- Day Hospital Thalassemia and Haemoglobinopathies (DHTE); A.O.U S.Anna — Ferrara
- Hospital Tunku Ampuan Besar Tuanku Aishah Rohani (HPKK UKM) — Kuala Lumpur
- Chulalongkorn University — Bangkok
Attica
- Children's Hospital Agia Sophia — Athens
- Laiko General Hospital of Athens — Athens
Gujarat
- Hemato-Oncology Clinic Ahmedabad PVT. LTD. — Ahmedabad
- Nirmal Hospital Pvt. Ltd - Surat — Surat
National Capital Territory of Delhi
- All India Institute of Medical Sciences, New Delhi — New Delhi
- Indraprastha Apollo Hospitals — New Delhi
New York
- Weill Cornell Medicine — New York
Kerala
- Amrita Institute of Medical Sciences and Research Centre (AIMS) — Kochi
Maharashtra
- K J Somaiya Super Specialty Hospital & Research Centre — Mumbai
Rajasthan
- JK Lon Hospital — Jaipur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2024-09-30 |
| Est. Completion | 2028-01-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06421636
The ClinicalTrials.gov registry entry for NCT06421636 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Transfusion Dependent Beta-Thalassemia (NTDT) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06421636 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Attica, Gujarat. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06421636 about?
NCT06421636 is a clinical study titled "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". 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, ...
What is the current status of trial NCT06421636?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2024-09-30. Estimated completion is 2028-01-24.
What conditions does trial NCT06421636 study?
This clinical trial studies the following conditions: Non-Transfusion Dependent Beta-Thalassemia (NTDT). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06421636?
The interventions under investigation include: Placebo (DRUG), REGN7999 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06421636?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06421636 being conducted?
This trial has 20 study locations across New York, Attica, Gujarat, Kerala, Maharashtra. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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