Eneboparatide for Hypoparathyroidism

(CALYPSO Trial)

Recruiting at55 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amolyt Pharma

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing eneboparatide, a new drug, in patients with chronic hypoparathyroidism. It aims to help these patients by mimicking the hormone they lack to better control calcium levels. The study will test eneboparatide for several months, followed by all participants receiving the drug for additional months.

Research Team

Soraya Allas, MD

Principal Investigator

Amolyt Pharma

Eligibility Criteria

Adults aged 18-80 with chronic hypoparathyroidism, requiring daily treatments for calcium and vitamin D intake. Participants must be able to self-inject medication or have someone who can do it for them, not be pregnant or breastfeeding, and have stable health without conditions that affect calcium metabolism. They should also not have had recent seizures or certain cancer treatments.

Inclusion Criteria

Prior to start of treatment:

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

I am between 18 and 80 years old.

Exclusion Criteria

I do not have any uncontrolled illnesses that could affect my stomach or intestines.

I have not taken oral bisphosphonates in the last 6 months or IV bisphosphonates in the last year.

Clinically significant abnormal values at screening for hematology, clinical chemistry, coagulation or urinalysis

Treatment Details

Interventions

• Eneboparatide (Parathyroid Hormone Analog)
• Placebo (Other)

Trial Overview The trial is testing eneboparatide (AZP-3601) against a placebo in patients with chronic hypoparathyroidism over a period of 52 weeks. Initially, participants won't know if they're receiving the actual drug or a placebo. After 24 weeks, all will receive eneboparatide in an open label extension phase.

Participant Groups

Group I: eneboparatide Experimental Treatment 1 Intervention

Starting dose of 20 mcg; Administered once daily by subcutaneous injection

Group II: Placebo Placebo Group 1 Intervention

Administered once daily by subcutaneous injection

Who Is Running the Clinical Trial?

Amolyt Pharma

Lead Sponsor

Trials

2

Recruited

300+