What side effects are associated with this type of intervention?

Common treatments for endocrine disorders, such as parathyroid hormone analogs (e.g., eneboparatide), can have several side effects. These may include hypercalcemia (elevated calcium levels in the blood), which can lead to symptoms like nausea, vomiting, constipation, and confusion. Other potential side effects include injection site reactions, dizziness, and headaches. For treatments like bisphosphonates, used in osteoporosis, side effects can include gastrointestinal issues, osteonecrosis of the jaw, and atypical femoral fractures. Aromatase inhibitors, used in hormone receptor-positive breast cancer, can cause loss of bone density, fractures, and cardiovascular risks.

What prior FDA approvals exist?

The FDA has approved several treatments for endocrine disorders, particularly those involving parathyroid hormone analogs. For instance, teriparatide (Forteo) is a recombinant form of parathyroid hormone approved for the treatment of osteoporosis in men and postmenopausal women at high risk for fractures. Another similar drug is abaloparatide (Tymlos), which is also a parathyroid hormone-related protein analog approved for the treatment of osteoporosis in postmenopausal women at high risk for fracture. These drugs work by stimulating bone formation, similar to the mechanism being studied for eneboparatide in the treatment of chronic hypoparathyroidism.

What other types of research exist?

Promising alternatives to Eneboparatide for endocrine disorders, particularly chronic hypoparathyroidism, include Natpara (recombinant human parathyroid hormone), which is already approved for hypoparathyroidism but has faced some supply issues. Additionally, abaloparatide and teriparatide, both parathyroid hormone-related protein analogs, are being explored for their potential benefits in managing hypoparathyroidism. These alternatives offer different mechanisms of action and administration routes, providing more options for personalized treatment plans.

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Parathyroid Hormone Analog

Eneboparatide for Hypoparathyroidism (CALYPSO Trial)

Phase 3

Waitlist Available

Research Sponsored by Amolyt Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions at the injection site, changes in blood pressure or heart rate, abnormal blood tests related to organ function, and possibly other symptoms associated with hormone therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy - Primary Endpoint

Secondary study objectives

Change from baseline in the HPT-DD-SE - Cognitive Domain score

Change from baseline in the HPT-DD-SE - Physical Domain score

Change from baseline in the HPT-LIQ - Physical Functioning Domain score

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: eneboparatideExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Administered once daily by subcutaneous injection

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endocrine disorders, such as parathyroid hormone analogs like eneboparatide, work by mimicking the natural hormones in the body to regulate various physiological processes. For instance, parathyroid hormone analogs help manage calcium levels in the blood by promoting calcium absorption in the intestines, reabsorption in the kidneys, and release from bones. This is crucial for patients with endocrine disorders like hypoparathyroidism, as it helps maintain normal calcium levels, preventing complications such as muscle cramps, seizures, and cardiac issues. Understanding these mechanisms allows for targeted therapy, improving patient outcomes and quality of life.