In short
This article discusses the ongoing clinical trials of eneboparatide (AZP-3601), a novel parathyroid hormone receptor agonist, for the treatment of chronic hypoparathyroidism. The CALYPSO study is a Phase 3 multicenter, randomized, placebo-controlled, double-blind trial aimed at assessing the efficacy and safety of eneboparatide in patients with this rare endocrine disorder. The trials focus on evaluating the drug's ability to reduce the need for active vitamin D and calcium supplements while maintaining normal serum calcium levels.
At a glance
- Drug Name
- Eneboparatide (AZP-3601)
- Drug Type
- Parathyroid hormone receptor agonist
- Condition Treated
- Chronic hypoparathyroidism
- Trial Phase
- Phase 3
- Trial Design
- Multicenter, randomized, placebo-controlled, double-blind
- Primary Objective
- Evaluate efficacy in reducing need for active vitamin D and oral calcium while maintaining normal serum calcium levels
- Key Secondary Objectives
- Assess effects on urinary calcium excretion, patient-reported physical and cognitive symptoms, health-related quality of life
- Administration Method
- Daily subcutaneous injection via pre-filled pen
- Treatment Duration
- 24 weeks (Main Treatment period)
- Key Inclusion Criteria
- Adults 18-80 years, chronic hypoparathyroidism for ≥12 months, requiring specific doses of vitamin D and calcium supplements
What is Eneboparatide?
Eneboparatide, also known as AZP-3601, is a new medication being developed to treat chronic hypoparathyroidism. It is classified as a parathyroid hormone receptor agonist, which means it works by mimicking the action of parathyroid hormone in the body.
How Does Eneboparatide Work?
Eneboparatide is designed to activate the parathyroid hormone receptor, which plays a crucial role in regulating calcium levels in the body. By doing so, it aims to help maintain normal calcium levels in patients with chronic hypoparathyroidism, potentially reducing the need for high doses of calcium and vitamin D supplements.
What Condition Does Eneboparatide Treat?
Eneboparatide is being developed to treat chronic hypoparathyroidism. This is a rare condition where the body doesn't produce enough parathyroid hormone, leading to low calcium levels and various symptoms. Patients with this condition often require lifelong treatment with calcium and vitamin D supplements.
Clinical Trial Information
Eneboparatide is currently being studied in a Phase 3 clinical trial called CALYPSO. This is an advanced stage of research that aims to confirm the effectiveness and safety of the drug. The trial is: Multicenter: Conducted at multiple hospitals or research centers Randomized: Participants are randomly assigned to receive either eneboparatide or a placebo Placebo-controlled: Some participants receive an inactive substance for comparison Double-blind: Neither the participants nor the researchers know who is receiving the actual drug or placebo
Potential Benefits
The main goals of the eneboparatide treatment being studied are: To eliminate the need for active vitamin D supplements To reduce the need for high doses of calcium supplements (aiming for 600 mg/day or less) To maintain normal blood calcium levels To improve physical and cognitive symptoms associated with hypoparathyroidism To enhance overall quality of life for patients
Administration and Dosage
Eneboparatide is administered as a subcutaneous injection, which means it's injected under the skin. It comes in a pre-filled injection pen, making it potentially easier for patients to self-administer at home. The maximum daily dose being studied is 100 micrograms, but the optimal dose may vary for each patient.
Eligibility for Treatment
While eneboparatide is still in clinical trials, the study includes adult patients aged 18 to 80 years who have had chronic hypoparathyroidism for at least 12 months. Patients must also be currently taking calcium and vitamin D supplements to manage their condition.
Safety Considerations
As with any medication, there are potential safety considerations. The clinical trial excludes patients with certain conditions or medical histories, such as: Recent history of certain cancers Severe kidney problems Certain heart conditions History of bone cancer (osteosarcoma) It's important to note that the full safety profile of eneboparatide is still being studied.