Eneboparatide for Hypoparathyroidism

(CALYPSO Trial)

Recruiting at 55 trial locations

Overseen By Amolyt Contact CTA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amolyt Pharma

Must be taking: Calcitriol, Alphacalcidol, Calcium supplements

Must not be taking: Diuretics, Corticosteroids, Bisphosphonates, others

Disqualifiers: Cancer, Seizures, Osteosarcoma risk, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

165 Participants Needed

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as loop and thiazide diuretics, lithium, and systemic corticosteroids, at least 4 weeks before starting the treatment. If you are on medications that affect calcium and bone metabolism, you may also need to stop those before joining the trial.

What data supports the effectiveness of the drug Eneboparatide for hypoparathyroidism?

Research on parathyroid hormone (PTH) therapy, similar to Eneboparatide, shows it can improve quality of life and reduce the need for vitamin D and calcium supplements in patients with hypoparathyroidism. Studies indicate that PTH therapy helps maintain normal calcium levels and reduces symptoms better than conventional treatments. ^{1 2 3 4 5}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive eneboparatide or placebo for 24 weeks, with treatment administered subcutaneously and individually titrated

24 weeks

Open-label extension

All participants receive eneboparatide for 132 weeks, including those initially in the placebo group

132 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Eneboparatide
• Placebo

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+

Findings from Research

PTH therapy likely provides a small improvement in physical health-related quality of life for patients with chronic hypoparathyroidism compared to conventional therapy, based on a systematic review of 7 randomized trials involving 386 patients.

PTH therapy significantly increases the likelihood of patients achieving a 50% or greater reduction in the dose of active vitamin D and calcium, although it may also raise the risk of hypercalcemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parathyroid Hormone Therapy for Managing Chronic Hypoparathyroidism: A Systematic Review and Meta-Analysis. Yao, L., Li, J., Li, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Parathyroid Hormone Therapy for Managing Chronic Hypoparathyroidism: A Systematic Review and Meta-Analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of hypoparathyroidism. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of parathyroid hormone rhPTH(1-84) on phosphate homeostasis and vitamin D metabolism in hypoparathyroidism: REPLACE phase 3 study. [2018]

5. Italy pubmed.ncbi.nlm.nih.gov

Burden of illness in patients with chronic hypoparathyroidism not adequately controlled with conventional therapy: a Belgium and the Netherlands survey. [2021]