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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a new treatment for chronic hypoparathyroidism, a condition where the body produces insufficient parathyroid hormone, leading to low calcium levels in the blood. The treatment being tested is called eneboparatide (AZP-3601), which is a type of medication known as a parathyroid hormone receptor agonist. This means it works by stimulating the receptors that respond to parathyroid hormone, potentially helping to regulate calcium levels in the body.

The study involves comparing eneboparatide with a placebo to see how well it works over a period of 24 weeks. Participants will receive either the eneboparatide or the placebo through a pre-filled pen for injection under the skin. The goal is to determine if eneboparatide can help patients reduce their need for active vitamin D and oral calcium supplements, while maintaining normal calcium levels in the blood. Additionally, the study will assess changes in symptoms and physical functioning of the participants.

Other medications involved in the study include alfacalcidol, calcitriol, and calcium carbonate, which are commonly used to manage calcium levels in patients with hypoparathyroidism. The study will monitor the effects of eneboparatide on these medications and evaluate its overall impact on the participants' health and quality of life. The trial is designed to provide valuable information on whether eneboparatide can be a beneficial treatment option for those living with chronic hypoparathyroidism.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the study, you will begin the Main Treatment (MT) period. This involves daily self-injections of the study medication, eneboparatide (AZP-3601), using a pre-filled pen. The injection is administered under the skin, typically in the abdomen.
You will also continue taking your regular doses of active vitamin D and oral calcium supplements as prescribed by your healthcare provider.
Step 2
Treatment duration
The treatment with eneboparatide will last for a total of 24 weeks. During this time, you will be required to maintain your daily routine of self-injections and oral supplements.
Regular monitoring of your serum calcium levels will be conducted to ensure they remain within the normal range.
Step 3
Monitoring and assessments
Throughout the study, you will undergo regular assessments to monitor your health and the effectiveness of the treatment. This includes blood tests to measure serum calcium and parathyroid hormone levels.
You will also be asked to complete questionnaires to evaluate any changes in your symptoms and overall well-being.
Step 4
End of treatment
At the end of the 24-week treatment period, a final assessment will be conducted. This will include blood tests and a review of your symptoms and any side effects experienced during the study.
The results will help determine the efficacy and safety of eneboparatide in managing chronic hypoparathyroidism.

Who can join the trial?

13 criteria

Patients must be between 18 and 80 years old.
Patients must have had chronic hypoparathyroidism (cHP) for at least 12 months, as shown in medical records.
Patients must have low levels of parathyroid hormone (PTH) and specific levels of serum calcium in their blood tests.
Patients must need treatment with at least 0.5 micrograms of calcitriol or 1 microgram of alphacalcidol per day, and need at least 1000 mg of extra oral calcium per day.
Patients must complete an Optimization period with stable calcium levels in their blood.
If patients are on treatment for thyroid cancer, their thyroid stimulating hormone (TSH) levels must be above 0.2 µIU/mL, and their thyroid medication dose must be stable for at least 6 weeks. In other cases, TSH levels must be within a specific range.
Patients must have normal levels of serum magnesium in their blood.
Patients must have vitamin D levels between 30 ng/mL and 70 ng/mL in their blood.
Patients must have a kidney function test result, called estimated glomerular filtration rate (eGFR), of at least 30 mL/minute/1.73 m² on two separate occasions.
Patients must be able to give themselves daily injections in the abdomen or have someone do it for them.
Female patients who can have children must agree to use a highly effective method of birth control during the study and for 30 days after the study ends. Male patients must ensure their female partners use effective birth control.
Female patients who can have children must have a negative pregnancy test at the start of the study.
Patients must be willing and able to sign a consent form and follow the study requirements.

Who cannot join the trial?

10 criteria

Patients with any other serious medical conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients who have an allergy to the study medication or similar drugs.
Patients who are unable to follow the study procedures or instructions.
Patients with unstable mental health conditions.
Patients who have been diagnosed with cancer in the past five years.
Patients with severe kidney or liver disease.

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Verified sites

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Hospital General Universitario De Valencia
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Valencia, Spain
Hospital Universitario De Navarra
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Pamplona, Spain
Hospital Universitario da A Coruna
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A Coruna Galicia, Spain

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Investigated drugs

Eneboparatide (AZP-3601) is a medication being studied for its potential to help people with chronic hypoparathyroidism. This condition occurs when the parathyroid glands in the neck do not produce enough parathyroid hormone, which is important for maintaining the right balance of calcium in the blood. Eneboparatide works by mimicking the action of this hormone, helping to increase calcium levels in the blood and reduce the need for additional calcium and vitamin D supplements. The goal of the study is to see if taking eneboparatide daily for 24 weeks can effectively manage calcium levels in patients with this condition.

What is already known about the treatment

Eneboparatide – Eneboparatide is administered as a daily injection and is currently being studied in a phase 3 clinical trial for its effectiveness and safety in treating chronic hypoparathyroidism. This condition is characterized by low levels of parathyroid hormone, leading to low calcium levels in the blood. Eneboparatide works by mimicking the action of the natural parathyroid hormone, helping to regulate calcium levels in the body. It is classified as a parathyroid hormone receptor agonist, which means it activates the same receptors as the natural hormone to achieve its effects.

Investigated diseases

Hypoparathyroidism – Hypoparathyroidism is a condition characterized by insufficient production of parathyroid hormone (PTH) by the parathyroid glands. This hormone is crucial for regulating and maintaining a balance of calcium and phosphorus in the body. The disease leads to low levels of calcium in the blood, known as hypocalcemia, and high levels of phosphorus, known as hyperphosphatemia. Symptoms often include muscle cramps, tingling sensations, and fatigue. As the condition progresses, it can cause more severe symptoms such as muscle spasms, seizures, and cardiac issues. The progression of hypoparathyroidism can vary, with some individuals experiencing mild symptoms and others facing more significant challenges.