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New drug could free patients from daily calcium pills

NCT ID NCT05778071

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests eneboparatide, a lab-made hormone, in 165 adults with chronic hypoparathyroidism. The goal is to see if it can help patients stop taking high-dose calcium and vitamin D supplements while keeping calcium levels normal. Participants receive either the drug or a placebo for 24 weeks, then all receive the drug for up to 132 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eneboparatide (AZP-3601), a synthetic hormone that mimics natural parathyroid hormone
What this could lead to
If successful, this treatment could help people with chronic hypoparathyroidism reduce or stop daily calcium and vitamin D supplements, improving their quality of life.
What could go wrong
This is a phase 3 trial, but results are not yet known. The drug may not work better than placebo, and side effects could occur. Long-term safety is still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 165 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males and Females, 18-80 years of age 2. Patients with cHP for ≥12 months at the time of screening 3. Two paired measurements of showing low parathyroid hormone (PTH) and serum calcium either below normal or within normal under standard of care 4. Requirement for therapy with calcitriol ≥0.5 mcg per day or alphacalcidol ≥1 mcg per day, and requirement for supplemental oral calcium treatment ≥1000 mg per day over and above patient's dietary calcium intake at Day 1 visit 5. Successful completion of the Optimization period based on two consecutive measurements of albumin-adjusted serum calcium at least 1 week apart within the range of 7.8 to 9.0 mg/dL and with no more than 25% of change in the daily dose of any of active vitamin D and oral calcium supplements between the two measurements 6. Thyroid-stimulating hormone (TSH) within the lower limit of normal and 1.5-fold of the upper limit of normal at screening; if on suppressive therapy for a history of thyroid cancer, TSH level must be ≥0.2 mIU/mL and thyroid medication should be stable for at least 6 weeks prior to treatment 7. Prior to start of treatment: * Magnesium level within laboratory normal limits * 25(OH) vitamin D levels of 30-70 ng/mL (75-175 nmol/L) 8. eGFR ≥30 mL/min/1.73m² during screening 9. Able to perform daily subcutaneous self-injections of study drug (or have a designee to perform injections) via a pre-filled injection pen 10. Female patients of non-childbearing potential or using an effective method of contraception throughout the study. Women of childbearing potential should have a negative pregnancy test. 11. Able and willing to provide written and signed informed consent in accordance with GCP Exclusion Criteria: 1. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation 2. Clinically significant abnormal values at screening for hematology, clinical chemistry, coagulation or urinalysis 3. Abnormal arterial pressure at screening, defined as (1) systolic blood pressure \<100 mmHg, or (2) systolic blood pressure \>150 mmHg, and/or diastolic blood pressure \>100 mmHg. 4. Heart rate at rest outside the range of 50-100 beats/minute at screening 5. Clinically significant abnormal standard 12-lead electrocardiogram indicative of severe cardiac disease 6. Known history of autosomal-dominant hypocalcemia or known pseudohypoparathyroidism (impaired responsiveness to PTH) 7. Any current disease (other than hypoparathyroidism) that might affect calcium metabolism, calcium-phosphate homeostasis or PTH levels 8. Patients with increased risk for osteosarcoma 9. Current uncontrolled active disease processes that may adversely affect gastrointestinal absorption 10. History of cerebrovascular accident within 6 months prior to screening 11. History of active uncontrolled malignancy over the past 2 years at time of screening 12. History of any other cancer other than thyroid cancer (except basal cell skin cancer or squamous cell skin cancer) who have not been disease-free for a period of at least 2 years at the time of screening 13. Acute gout \<2 months prior to screening 14. Dependent on parenteral calcium infusions to maintain calcium homeostasis 15. Use of medications such as loop and thiazide diuretics, raloxifene hydrochloride, lithium, methotrexate, cardiac glycosides or systemic corticosteroids within 4 weeks prior to start of treatment 16. Previous treatment with PTH/parathyroid hormone-related protein-like drugs, including PTH(1-84) and PTH(1-34) within 3 months of screening 17. Use of other drugs known to influence calcium and bone metabolism within 4 weeks of screening 18. Use of oral bisphosphonates within 6 months of screening or intravenous bisphosphonate within 12 months of screening 19. Use of denosumab within 18 months of screening 20. Seizure disorder/epilepsy with history of a seizure within 6 months of screening 21. History of symptomatic urinary tract calculi within 3 months of screening 22. Irradiation to the skeleton within 2 years of screening 23. Pregnant or breastfeeding female patients 24. Participation in any other interventional study in which the patient received an investigational drug or device within 2 months or within 5 times the half-life of the investigational drug (whichever comes first) prior to screening 25. Any disease or condition that, in the opinion of the investigator, may require treatment or make the subject unlikely to fully complete the trial, or any condition that presents undue risk from the study treatment or procedures, including treated malignancies that are likely to recur within the approximate duration of the trial 26. Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule 27. Known allergy or sensitivity to PTH or any of the excipients

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Conditions

The condition(s) this trial relates to.

endocrine system disorder hypoparathyroidism parathyroid gland disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hypoparathyroidism Endocrine system diseases Parathyroid diseases

Contacts and locations

Locations

  • Aarhaus University Hospital

    Aarhus, 8200, Denmark

  • Academy of Diabetes, Thyroid and Endocrine

    El Paso, Texas, 79935, United States

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204, United States

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliera Universitaria Pisana-Ospedale di Cisanello

    Pisa, 56124, Italy

  • Azienda Ospedaliero Universitaria de Bologna, Policlinico Sant Orsola Malpighi

    Bologna, 40138, Italy

  • Bone Research and Education Center

    Oakville, Ontario, L6M 1M1, Canada

  • CHU de Nantes - Hôtel-Dieu

    Nantes, 44093, France

  • CHU de Quebec Research Centre

    Québec, G1V 4G2, Canada

  • Cendrum Zdrowi MDM - EB Group Sp.

    Warsaw, 00189, Poland

  • Centro Hospital Vila Nova de Faia/Espinho

    Porto, 4434-502, Portugal

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Colombia University Irving Medical Center

    New York, New York, 10032, United States

  • Complejo Hospitalario Universitario de A Coruna

    A Coruña, 15006, Spain

  • Denver Endocrinology Diabetes and Thyroid Center

    Denver, Colorado, 80113, United States

  • Eastern Regional Health Authority Health Sciences Centre

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Eramus MC - University Medical Center

    Rotterdam, 3015 GD, Netherlands

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

    Milan, 20122, Italy

  • Harbor UCLA Medical Center Endocrinology

    Torrance, California, 90502, United States

  • Hopital de la Conception-APHM

    Marseille, 13385, France

  • Hospital Bicetre AP-HP

    Paris, 94275, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital da Luz Lisboa

    Lisbon, 1500-650, Portugal

  • Indiana University (IU) Health University Hospital

    Indianapolis, Indiana, 46202, United States

  • Instytut Centrum Zdrowia Matki Polki. Klinika Endokrynologii Chorob Metabolicznych

    Lodz, 93-338, Poland

  • Kanazawa University Hospital

    Kanazawa, Japan

  • Leiden University Medical Center

    Leiden, 2333, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medicover Neuroendokrinologie MVZ

    Munich, 81667, Germany

  • Medycyny Nuklearnej i Chorob Wewnetrznych

    Krakow, 30-688, Poland

  • Norfolk & Norwich University NHS Foundation Trust, Quadrum Institute

    Norwich, NR4 7UQ, United Kingdom

  • North Shore University Health System

    Evanston, Illinois, 60201, United States

  • Northern Nevada Endocrinology

    Reno, Nevada, 89511, United States

  • Osaka City Hospital

    Osaka, Japan

  • Osaka Metropolital University Hospital

    Osaka, Japan

  • Pecsi Tudomanyegyetem

    Pécs, 7624, Hungary

  • Physician's East Endocrinology

    Greenville, North Carolina, 27834, United States

  • Rigshospitalet

    Copenhagen, Denmark

  • Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika

    Budapest, 1083, Hungary

  • Teikyo University Chiba Medical Center

    Chiba, Japan

  • The Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania, 19104, United States

  • The Children's Hospital of Philadephia

    Philadelphia, Pennsylvania, 19104, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Tokushima University Hospital

    Tokushima, Japan

  • Tottori University Hospital

    Tottori, Japan

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97080, Germany

  • Universitatsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307, Germany

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW, United Kingdom

  • University of Chicago - Medical Center

    Chicago, Illinois, 60637, United States

  • Via Alvaro del Portillo, 200, Roma, Italy 00128

    Roma, 00128, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.