A Phase 3 Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism

Launched by ASCENDIS PHARMA BONE DISEASES A/S · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called palopegteriparatide, which is used to treat adults with hypoparathyroidism—a condition where the body doesn’t make enough parathyroid hormone, leading to low calcium levels. The goal of the study is to see if higher doses (more than 30 micrograms per day) of this medicine are safe and effective in helping manage this condition. The trial will last about 78 weeks and take place in the United States.

Adults who have had hypoparathyroidism for at least six months and are already taking palopegteriparatide at doses of 30 micrograms or higher may be able to join. Participants need to have certain lab tests within a normal or near-normal range and meet other health criteria. During the study, everyone will receive palopegteriparatide as an injection under the skin, and their dose will be carefully adjusted to find the best level for their treatment. The study is currently not recruiting yet, but it aims to better understand how well this medicine works at higher doses and to ensure it remains safe for patients.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Males and females, ≥18 years of age at the time of providing informed consent
• • 2. Participants with postsurgical chronic hypoparathyroidism (HP), or auto-immune, genetic, or idiopathic HP, for at least 26 weeks
• • 3. Receiving doses of palopegteriparatide at or above 30 µg/day
• For individuals receiving 30 µg/day: evidence that dose is insufficient to keep serum calcium in the normal range, defined as:
• • Documented hypocalcemia in the 12 weeks prior to Screening; and/or Standing dose of calcitriol ≥0.5 μg/day, and / or (elemental) calcium ≥800 mg/day (e.g., calcium citrate, calcium carbonate etc.) for at least 12 weeks prior to Screening
• • For individuals receiving 33 µg/day or greater: no requirement for documented hypocalcemia or minimum doses of calcitriol or elemental calcium
• 4. Confirmation of laboratory parameters (Central and Local) within 2 weeks of screening visit:
• • 25(OH) vitamin D levels of 20 - 80 ng/mL (49 - 200 nmol/L) and Magnesium level in the normal range, or just below the normal range i.e.: ≥1.3 mg/dL (≥0.53 mmol/L) and Albumin-adjusted or ionized sCa level in the normal range or just below the normal range
• • Albumin-adjusted sCa 7.8 - 10.6 mg/dL (or 1.95 - 2.64 mmol/L)
• • Ionized sCa 4.40 - 5.29 mg/dL (1.10 - 1.32 mmol/L)
• • 5. BMI 17- 40 kg/m2 at Screening
• • 6. If ≤25 years of age, radiological evidence of epiphyseal closure based on locally interpreted X-ray of non-dominant wrist and hand
• • 7. eGFR ≥30 mL/min/1.73 m2 during Screening
• • Exclusion criteria
• • 1. Impaired responsiveness to PTH (pseudohypoparathyroidism), which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia
• • 2. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HP
• • 3. Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin \>30 µg/day, or systemic corticosteroids (other than as replacement therapy)
• • 4. Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1
• • 5. Use of PTH-like drugs other than palopegteriparatide (whether commercially available or through participation in an investigational trial), including PTH(1-34), or other N-terminal fragments, analogs of PTH or PTH-related protein, or PTH1R biased agonists within 4 weeks prior to Screening
• • 6. Use of drugs known to influence calcium and bone metabolism within 12 weeks prior to Screening
• • 7. Use of osteoporosis therapies known to influence calcium and bone metabolism within 2 years prior to Screening
• • 8. Non-hypocalcemic seizure disorder with occurrence of a seizure within 26 weeks prior to Screening.
• • 9. Increased risk for osteosarcoma
• • 10. Women who are pregnant, intend to become pregnant, or are lactating
• • 11. Male who has a female partner who intends to become pregnant or is of childbearing potential and is unwilling to use adequate contraceptive methods during the trial
• • 12. Diagnosed drug or alcohol dependence within 3 years prior to Screening
• • 13. Chronic or severe cardiac disease within 26 weeks prior to Screening
• • 14. Cerebrovascular accident within 5 years prior to Screening.
• • 15. Within 26 weeks prior to Screening: acute colic due to nephrolithiasis, or acute gout
• • 16. Participation in any other interventional trial in which receipt of investigational drug or device other than palopegteriparatide occurred within 8 weeks (or within 5.5 times the half-life of the investigational drug) (whichever comes first) prior to Screening.
• • 17. Known allergy or sensitivity to PTH or any of the excipients \[metacresol, mannitol, succinic acid, NaOH/(HCl)\] of the investigational product