A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide… (NCT07081997) | Clinical Trial Compass
RecruitingPhase 3
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
United States36 participantsStarted 2026-04-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females, ≥18 years of age at the time of providing informed consent
✓. Participants with postsurgical chronic hypoparathyroidism (HP), or auto-immune, genetic, or idiopathic HP, for at least 26 weeks
✓. Receiving doses of palopegteriparatide at or above 30 µg/day
✓. Confirmation of laboratory parameters (Central and Local) within 2 weeks of screening visit and prior to randomization:
Exclusion criteria
✕. Impaired responsiveness to PTH (pseudohypoparathyroidism), which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia
✕. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HP
✕. 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)
✕. Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1
✕. 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
✕. Use of drugs known to influence calcium and bone metabolism within 12 weeks prior to Screening
✕. Use of osteoporosis therapies other than bisphosponate known to influence calcium and bone metabolism within 2 years prior to Screening. Note: use of bisphosphonate (oral or intravenous \[IV\] is not exclusionary
✕. Non-hypocalcemic seizure disorder with occurrence of a seizure within 26 weeks prior to Screening.