Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism
Public ClinicalTrials.gov record NCT05778071. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Eneboparatide (AZP-3601), a Parathyroid Hormone Receptor Agonist, in Patients With Chronic Hypoparathyroidism (CALYPSO)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is investigating the safety and efficacy of eneboparatide (AZP-3601) in patients with chronic hypoparathyroidism (cHP). During the first 24 weeks of the trial, participants will be randomized to receive eneboparatide or placebo. Study treatment is blinded: patients and doctors will not know which group each patient has been randomized to. All patients will start with a fixed dose of study treatment (eneboparatide or placebo), administered subcutaneously with a pre-filled pen. Study treatment will be individually titrated. After completion of the first 24 weeks, patients will be treated in the open label extension part of the study for 132 weeks. During this phase, all patients (including patients that were in the placebo group) will receive eneboparatide.
Study identification
- NCT ID
- NCT05778071
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 165 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 7, 2023 (Actual)
- Primary completion
- Nov 15, 2024 (Actual)
- Completion
- Jun 16, 2027 (Estimated)
- Last update posted
- Sep 29, 2025
2023 – 2027
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harbor UCLA Medical Center Endocrinology | Torrance | California | 90502 | — |
| Denver Endocrinology Diabetes and Thyroid Center | Denver | Colorado | 80113 | — |
| University of Chicago - Medical Center | Chicago | Illinois | 60637 | — |
| North Shore University Health System | Evanston | Illinois | 60201 | — |
| Indiana University (IU) Health University Hospital | Indianapolis | Indiana | 46202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Northern Nevada Endocrinology | Reno | Nevada | 89511 | — |
| Colombia University Irving Medical Center | New York | New York | 10032 | — |
| Physician's East Endocrinology | Greenville | North Carolina | 27834 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| The Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | 19104 | — |
| The Children's Hospital of Philadephia | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Academy of Diabetes, Thyroid and Endocrine | El Paso | Texas | 79935 | — |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05778071, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2025 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05778071 live on ClinicalTrials.gov.