RecruitingPhase 3NCT07081997

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

A Phase 3, Multicenter, Randomized, Open-Label Trial Investigating the Safety, Tolerability and Efficacy of Palopegteriparatide Administered Subcutaneously Daily at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism


Sponsor

Ascendis Pharma Bone Diseases A/S

Enrollment

36 participants

Start Date

May 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This trial has a treatment 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Palopegteriparatide Control Arm and Palopegteriparatide Experimental Arm for people with endocrine system diseases, hypoparathyroidism, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTPalopegteriparatide Experimental Arm

Palopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks.

COMBINATION_PRODUCTPalopegteriparatide Control Arm

Palopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks.


Locations(7)

Ascendis Pharma Investigational Site

Chicago, Illinois, United States

Ascendis Pharma Investigational Site

Minneota, Minnesota, United States

Ascendis Pharma Investigational Site

Reno, Nevada, United States

Ascendis Pharma Investigational Site

New York, New York, United States

Ascendis Pharma Investigational Site

Greenville, North Carolina, United States

Ascendis Pharma Investigational Site

Houston, Texas, United States

Ascendis Pharma Investigational Site

Spokane Valley, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07081997


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