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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 (PaTHway60)

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Ascendis Pharma

Status and phase

Begins enrollment in 2 months
Phase 3

Conditions

Parathyroid Diseases
Endocrine System Diseases
Hypoparathyroidism

Treatments

Combination Product: Palopegteriparatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT07081997
ASND0052

Details and patient eligibility

About

This trial has a duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg/day. All participants will receive subcutaneous palopegteriparatide during the trial and will be individually and progressively titrated to an optimal dose at pre-specified dose levels. The primary purpose of the trial is to provide additional evidence of treatment effect and safety of palopegteriparatide at doses greater than 30 mcg/day in adults with hypoparathyroidism. The trial will be conducted in the US.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

    1. BMI 17- 40 kg/m2 at Screening

    2. If ≤25 years of age, radiological evidence of epiphyseal closure based on locally interpreted X-ray of non-dominant wrist and hand

    3. 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Palopegteriparatide
Experimental group
Description:
Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose
Treatment:
Combination Product: Palopegteriparatide

Trial contacts and locations

0

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Central trial contact

Ascendis Registry Inquiries

Data sourced from clinicaltrials.gov

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