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

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What is this study about?

This clinical trial is focused on studying the effects 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 parathyroid hormone receptor agonist. This means it is designed to mimic the action of the natural hormone to help regulate calcium levels in the body. The study will compare the effects of eneboparatide with a placebo to see how well it works in managing the disease.

Participants in the study will receive either eneboparatide or a placebo for a period of 24 weeks. The treatment is administered through a pre-filled pen for subcutaneous injection, which means it is injected under the skin. The goal is to evaluate how effective eneboparatide is in reducing the need for active vitamin D and oral calcium supplements, and in maintaining normal serum calcium levels. The study will also assess changes in symptoms and physical functioning of the participants.

In addition to eneboparatide, the study involves other medications such as calcitriol and calcium carbonate, which are commonly used to manage calcium levels. Another medication, alfacalcidol, is also part of the study. These medications are used to help understand the overall effectiveness of the new treatment. The study aims to provide valuable information on the safety and benefits of eneboparatide for people living with chronic hypoparathyroidism.

1 beginning of treatment

Upon joining the study, you will begin the Main Treatment (MT) period. This involves taking part in a 24-week treatment phase.

During this period, you will receive a daily treatment with a medication called eneboparatide (AZP-3601), which is administered through a subcutaneous injection. This means the medication is injected under the skin using a pre-filled pen.

2 medication and supplements

You will continue to take your regular doses of active vitamin D and oral calcium supplements as prescribed. The goal is to evaluate the effect of eneboparatide on reducing the need for these supplements.

The specific medications you may be taking include calcitriol (0.25 microgram capsule) or alfacalcidol (0.50 microgram capsule) for vitamin D, and calcium carbonate (500 mg tablet) for calcium.

3 monitoring and assessments

Throughout the trial, your health will be closely monitored. This includes regular blood tests to check your serum calcium levels and other relevant health indicators.

You will also be asked to complete questionnaires to assess any changes in your symptoms and overall well-being.

4 end of treatment evaluation

At the end of the 24-week treatment period, your response to the medication will be evaluated. This includes checking if you have achieved independence from active vitamin D and oral calcium supplements.

Your serum calcium levels will be assessed to ensure they are within the normal range.

Who Can Join the Study?

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 extra oral calcium of at least 1000 mg per day, in addition to their dietary calcium intake.
Patients must have completed the Optimization period successfully, with specific levels of albumin-adjusted serum calcium in two tests at least one week apart.
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 before starting the study. In other cases, TSH levels should be within a specific range.
Patients must have normal levels of serum magnesium before starting the study.
Patients must have serum 25-hydroxy vitamin D levels between 30 ng/mL and 70 ng/mL before starting the study.
Patients must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/minute/1.73 m² in two separate tests, with at least one recent test.
Patients must be able to perform daily self-injections of the study treatment in the abdomen, or have someone who can do it for them, using a pre-filled injection pen.
Female patients must either not be able to have children (due to menopause, hysterectomy, or removal of ovaries) or must agree to use a highly effective method of contraception during the study and for 30 days after the treatment ends. Male patients must ensure their female partners use a highly effective method of contraception during the study and for 30 days after the treatment ends.
Women who can have children must have a negative pregnancy test at the start of the study and at the Day 1 visit.
Patients must be willing and able to sign the Informed Consent Form and follow the study requirements.

Who Cannot Join the Study?

Patients with any condition other than hypoparathyroidism cannot participate. Hypoparathyroidism is a condition where the body produces too little parathyroid hormone, which helps control calcium levels in the blood.
Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
Patients who are not willing to stop taking certain medications that might interfere with the study cannot participate.
Patients who have a history of certain medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to comply with the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Of Pecs	Pecs	Hungary
Centre Hospitalier Universitaire De Lille	Lille	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
Unidade Local De Saude De Gaia/Espinho E.P.E.	Vila Nova De Gaia	Portugal
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Eb Group Sp. z o.o.	Warsaw	Poland
Universita’ Di Pisa	Pisa	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Da Luz S.A.	Lisbon	Portugal
Semmelweis University	Budapest	Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Universitair Ziekenhuis Gent	Gent	Belgium
Cigfflj Uzctelbtohj Dx Nfnxmsx	Madrid	Spain
Eibayus Udsusxjokdjd Mzylcli Cufuuaj Rjnqbnyvx (jnyasko Mmk	Rotterdam	The Netherlands
Uehreqarrdxfxrfwqyeaa Wxsdodctz Afd	Wuerzburg	Germany
Anknyyr Uwvfo Srzodjmzn Lavtdt Dl Bilrbai	Bologna	Italy
Ubgwweeutu Hraujssrl Pccai Skxcuwghvcs Cirgtrm Fqte	Paris	France
Hpkplawt Vimn dlgbzyny	Barcelona	Spain
Hmxzdyoe Ubsecqadezvnh dj A Cjxzpf	A Coruna Galicia	Spain
Cxo Kfwahvl Boonyhs	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.12.2023
Denmark	Not recruiting	01.12.2023
France	Not recruiting	01.12.2023
Germany	Not recruiting	01.12.2023
Hungary	Not recruiting	01.12.2023
Italy	Not recruiting	01.12.2023
Poland	Not recruiting	01.12.2023
Portugal	Not recruiting	01.12.2023
Spain	Not recruiting	01.12.2023
The Netherlands	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

Eneboparatide 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. In this clinical trial, researchers are testing whether taking eneboparatide daily for 24 weeks can effectively manage calcium levels and reduce the need for other treatments like active vitamin D and oral calcium supplements.

Investigated diseases:

Hypoparathyroidism

Hypoparathyroidism – Hypoparathyroidism is a condition characterized by insufficient production of parathyroid hormone, which is crucial for regulating calcium and phosphorus levels in the body. This deficiency leads to low levels of calcium in the blood and high levels of phosphorus. The disease progresses with symptoms such as muscle cramps, tingling in the fingers, and fatigue. Over time, patients may experience more severe symptoms like muscle spasms, seizures, and heart problems. The condition can also affect the skin, hair, and nails, causing them to become dry and brittle. Long-term management focuses on maintaining balanced calcium and phosphorus levels to prevent complications.

Trial ID:

2022-503126-12-01

Protocol code:

AZP-3601-CLI-002

NCT ID:

NCT05778071

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?