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

Part of paid clinical trials in Reno, Nevada.

Sponsor
Ascendis Pharma Bone Diseases A/S
Study ID
NCT07081997
Phase
PHASE3
Status
Recruiting
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Conditions

  • Endocrine System Diseases
  • Hypoparathyroidism
  • Parathyroid Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palopegteriparatide Experimental Arm — COMBINATION_PRODUCT
    Palopegteriparatide is supplied as a solution with a concentration of 0.3 mg/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
  • Palopegteriparatide Control Arm — COMBINATION_PRODUCT
    Palopegteriparatide is supplied as a solution with a concentration of 0.3 mg/mL in a single-patient-use prefilled pen intended for subcutaneous injection.

Study Details

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.

Key Dates

Start date
Apr 16, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Palopegteriparatide Experimental Arm
    Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose by a novel titration algorithm.
  • Active Comparator: Palopegteriparatide Control Arm
    Palopegteriparatide at doses at or greater than 30 mcg delivered once daily by subcutaneous injection and titrated to an optimal dose by a previously evaluated titrated algorithm

Primary Outcome Measure

Efficacy - Primary endpoint [ Time Frame: 26 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Ascendis Pharma Investigational SiteRenoNevada89511-
Ascendis Pharma Investigational SiteNew YorkNew York10032-
Ascendis Pharma Investigational SiteSpokane ValleyWashington99216-

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By research site
Ascendis Pharma Investigational Site· Reno, NVAscendis Pharma Investigational Site· New York, NYAscendis Pharma Investigational Site· Spokane Valley, WA

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