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[Ala1,3,12,Gln10,Arg11,Trp14]Pth(1-14)/[Ala18,22, Lys26]Pthrp(15-36)Cooh

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.

Table of Contents

What is Eneboparatide?

Eneboparatide, also known as AZP-3601, is a new medication being developed to treat chronic hypoparathyroidism[1]. It is classified as a parathyroid hormone receptor agonist, which means it works by mimicking the action of parathyroid hormone in the body[1].

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[1].

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[1].

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[1]. 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[1]:

  • 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[1]. The maximum daily dose being studied is 100 micrograms, but the optimal dose may vary for each patient[1].

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[1].

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[1].

Aspect Details
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

FAQ

  • What is eneboparatide and how does it work? Eneboparatide (AZP-3601) is a parathyroid hormone receptor agonist designed to treat chronic hypoparathyroidism. It works by mimicking the action of parathyroid hormone, helping to regulate calcium levels in the body.
  • What is the main goal of the CALYPSO clinical trial? The main goal of the CALYPSO trial is to demonstrate the efficacy of daily eneboparatide treatment for 24 weeks compared to placebo. It aims to show reduced need for active vitamin D and oral calcium supplements while maintaining normal serum calcium levels.
  • Who is eligible to participate in the clinical trial? Eligible participants are adults aged 18 to 80 with chronic hypoparathyroidism for at least 12 months. They must require specific doses of calcitriol or alphacalcidol and oral calcium supplements. Other criteria include normal magnesium levels and adequate kidney function.
  • What are some of the key outcomes being measured in the trial? Key outcomes include the proportion of patients achieving independence from active vitamin D, reduced need for oral calcium supplements, and maintaining normal serum calcium levels. The trial also assesses changes in urinary calcium excretion and improvements in patients' physical and cognitive symptoms.
  • How is eneboparatide administered in the clinical trial? Eneboparatide is administered as a daily subcutaneous injection using a pre-filled pen. Patients or their designees must be able to perform these self-injections in the abdomen.

Ongoing Clinical Trials on [Ala1,3,12,Gln10,Arg11,Trp14]Pth(1-14)/[Ala18,22, Lys26]Pthrp(15-36)Cooh

  • Study on the Effectiveness and Safety of Eneboparatide in Patients with Chronic Hypoparathyroidism

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of Eneboparatide, Calcitriol, and Calcium Carbonate for Patients with Chronic Hypoparathyroidism

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark France Germany Hungary Italy +4

Glossary

  • Chronic hypoparathyroidism: A rare endocrine disorder characterized by inadequate production of parathyroid hormone, leading to low calcium levels in the blood and various associated symptoms.
  • Parathyroid hormone receptor agonist: A substance that binds to and activates the parathyroid hormone receptor, mimicking the effects of natural parathyroid hormone in the body.
  • Serum calcium: The amount of calcium present in the blood. Maintaining normal levels is crucial for various bodily functions, including muscle and nerve function.
  • Calcitriol: An active form of vitamin D used to treat low calcium levels in patients with hypoparathyroidism.
  • Hypercalciuria: A condition characterized by excessive calcium excretion in the urine, which can be a complication of hypoparathyroidism treatment.
  • Albumin-adjusted serum calcium: A measurement of calcium in the blood that takes into account the level of albumin, a protein that binds to calcium. This provides a more accurate assessment of calcium status.
  • Subcutaneous injection: An injection administered into the fatty tissue layer beneath the skin, used for medications like eneboparatide that need to be absorbed slowly into the bloodstream.
  • Patient Reported Outcomes (PRO): Assessments that come directly from patients about how they feel or function in relation to a health condition and its therapy, without interpretation by healthcare professionals or anyone else.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-eneboparatide-in-patients-with-chronic-hypoparathyroidism/