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A study to evaluate the safety and effects of palopegteriparatide in adolescents with chronic hypoparathyroidism

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study aims to evaluate the effectiveness of palopegteriparatide in adolescents living with Chronic Hypoparathyroidism. This condition is a rare disease where the parathyroid glands, which are small glands in the neck, do not produce enough hormone to keep the levels of calcium in the blood at a healthy level. Low calcium levels can affect how muscles and nerves function throughout the body.

The treatment being studied is palopegteriparatide, which is administered through subcutaneous injection. This means the medicine is delivered by injecting it into the fatty layer of tissue just under the skin using a pre-filled pen. Participants will receive this medication daily during the course of the study to see how it affects their ability to maintain healthy mineral levels without needing large amounts of supplemental vitamin D or high doses of calcium tablets.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Daily medication administration

    The palopegteriparatide medication is administered once every day through a subcutaneous injection, which means the medicine is injected into the fatty layer of tissue just under the skin using a pre-filled pen.

    Depending on the specific dosage assigned, the injection will use one of three available strengths: 420 micrograms/1.4 mL, 294 micrograms/0.98 mL, or 168 micrograms/0.56 mL.

  2. Step 2

    Monitoring and assessment

    During the trial, measurements are taken to check the levels of calcium in the blood. these levels are adjusted based on albumin, which is a protein in the blood, to ensure the results are accurate.

    At week 26, the effectiveness of the treatment is evaluated by checking if serum calcium levels are within the normal range.

  3. Step 3

    Evaluation of supplement independence

    At the 26-week mark, the ability to reduce other treatments is assessed.

    The goal is to reach independence from active vitamin D and to reduce calcium doses to a supplemental level, which is defined as 600 mg/day or less, rather than using therapeutic doses to treat chronic hypoparathyroidism (a condition where the body does not produce enough parathyroid hormone).

Who can join the trial?

9 criteria

  • The study is open to both males and females who are between 12 and 17 years old at the time they join the study.
  • Participants must have had chronic hypoparathyroidism, which is a long-term condition where the body does not produce enough parathyroid hormone (PTH), for at least 26 weeks.
  • This condition may have started due to surgery, an auto-immune response (where the body's immune system attacks its own healthy cells), genetics, or idiopathic reasons (meaning the cause is unknown).
  • To be included, patients must have a history of hypocalcemia, which means having calcium levels in the blood that are lower than the normal range, occurring alongside low PTH levels.
  • Patients must have normal levels of vitamin D and magnesium in their blood before being assigned to a study group.
  • The patient's estimated glomerular filtration rate (eGFR), which is a measure used to check how well the kidneys are filtering waste from the blood, must be 30 mL/min/1.73 m2 or higher.
  • The patient's Body Mass Index (BMI) Z-score, which is a way to compare a person's weight relative to their height and age, must be within a specific healthy range between -2 SDS and +3 SDS.
  • A parent or legal representative must provide written, signed informed consent, which is formal permission to participate in the study.
  • The participant must also provide assent, which is a formal agreement from the minor to participate in the study according to local rules.

Who cannot join the trial?

17 criteria

  • You cannot participate if your body does not respond well to PTH (parathyroid hormone, a hormone that helps control calcium levels), which is shown by high levels of the hormone alongside hypocalcemia (low calcium levels in the blood).
  • Women who are pregnant, plan to become pregnant, or are lactating (breastfeeding) cannot join. Sexually active women must use effective birth control during the study and for two weeks after the last dose.
  • A diagnosis of drug or alcohol dependence within the last 3 years before starting the study is an exclusion.
  • Having severe or symptomatic cardiac disease (heart problems) within the last 26 weeks, such as congestive heart failure (heart not pumping blood well), valvular disease (problems with heart valves), myocardial infarction (heart attack), arrhythmias (irregular heartbeat), bradycardia (slow heart rate), hypotension (low blood pressure), or hypertension (high blood pressure).
  • Having a cerebrovascular accident (a stroke) within the last 5 years.
  • Having acute colic (severe, sudden pain) caused by nephrolithiasis (kidney stones) or gout (a type of painful joint inflammation) within the last 26 weeks. People with kidney stones that do not cause symptoms are allowed to participate.
  • Taking part in another medical study involving a new drug or device within the last 8 weeks.
  • Having a known allergy or sensitivity to PTH or any of the inactive ingredients used to make the study medicine.
  • Any other medical reason that, in the doctor's opinion, would prevent you from finishing the study or following the schedule.
  • Having any other condition that affects how your body handles calcium, phosphate, or PTH levels, such as hyperthyroidism (overactive thyroid), Paget disease of bone (a condition affecting bone growth), hypomagnesemia (low magnesium levels), diabetes mellitus (uncontrolled blood sugar), severe liver or renal disease (liver or kidney disease), Cushing syndrome (hormone imbalance), multiple myeloma (a type of blood cancer), pancreatitis (inflammation of the pancreas), malnutrition, rickets (bone softening), malignancy (active cancer), hyperparathyroidism (overactive parathyroid glands), acromegaly (excess growth hormone), or certain genetic hormone disorders.
  • Using specific medications including loop diuretics (water pills), phosphate binders (medicines that prevent the body from absorbing phosphate), digoxin, lithium, methotrexate, high doses of biotin, or systemic corticosteroids (steroid medicines), unless the steroids are used as a replacement therapy.
  • Using thiazide diuretics (a type of water pill) within 4 weeks before a scheduled 24-hour urine test.
  • Using any PTH-like drugs (medicines that act like parathyroid hormone) within the last 4 weeks.
  • Using other medicines that affect calcium and bone health, such as calcitonin, high doses of fluoride, strontium, or cinacalcet hydrochloride, within the last 12 weeks.
  • Using osteoporosis (bone thinning) treatments like bisphosphonates, denosumab, raloxifene, or romosozumab within the last 2 years.
  • Having a seizure disorder (convulsions) that is not caused by low calcium, if a seizure has occurred within the last 26 weeks.
  • Having an increased risk for osteosarcoma (a type of bone cancer), such as having Paget's disease of bone, unexplained high levels of alkaline phosphatase (an enzyme in the blood), certain genetic disorders, or a history of radiation therapy to the bones.
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Investigated drugs

Yorvipath is an injectable medication used to treat people with chronic hypoparathyroidism. It works by helping the body manage calcium and phosphorus levels, which are often unbalanced in people with this condition.

What is already known about the treatment

Palopegteriparatide - This medication is an injection administered once daily through a small needle under the skin. It is currently being studied in clinical trials to treat a rare condition called chronic hypoparathyroidism, which involves low levels of calcium in the body. As a parathyroid hormone analog, it works by mimicking the natural hormone that regulates calcium levels, helping to keep them stable at a molecular level. This drug belongs to a class of medications used to manage hormonal imbalances.

Investigated diseases

Chronic hypoparathyroidism - This condition occurs when the parathyroid glands do not produce enough parathyroid hormone. This hormone is essential for maintaining the correct levels of calcium in the blood. When levels are too low, it can lead to disturbances in how the body handles minerals. The condition often progresses with persistent imbalances in calcium and phosphate levels. Over time, these imbalances can affect various bodily functions and muscle movements.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-523928-52-00Protocol codeASND0035Estimated enrolment21 patientsSponsorAscendis Pharma Bone Diseases A/S

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