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Tests treatment safety and results for Hypoparathyroidism
Official title 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
ClinicalTrials.gov ID: NCT07081997
What this study is testing
What is Palopegteriparatide Experimental Arm?
Palopegteriparatide Experimental Arm is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypoparathyroidism.
Also referred to as Yorvipath.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 For individuals receiving 30 µg/day: evidence that dose is insufficient to keep serum...
- Confirmation of laboratory parameters (Central and Local) within 2 weeks of screening visit and prior to randomization: 25(OH) vitamin D levels of 20...
- Albumin-adjusted sCa 7.8 - 10.6 mg/dL (or 1.95 - 2.64 mmol/L)
You likely can't join if
- Impaired responsiveness to PTH (pseudohypoparathyroidism), which is characterized as PTH-resistance, with elevated PTH levels in the setting of...
- 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...
- 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...
- Use of drugs known to influence calcium and bone metabolism within 12 weeks prior to Screening
See the full eligibility 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 For individuals receiving 30 µg/day: evidence that dose is insufficient to keep serum calcium in the normal range, defined as: Documented hypocalcemia within...
- Confirmation of laboratory parameters (Central and Local) within 2 weeks of screening visit and prior to randomization: 25(OH) vitamin D levels of 20 - 80 ng/mL (49 - 200 nmol/L) and Magnesium level in 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...
- 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...
- 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.
- Increased risk for osteosarcoma
- Women who are pregnant, intend to become pregnant, or are lactating
- 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
- Diagnosed drug or alcohol dependence within 3 years prior to Screening
- Chronic or severe cardiac disease within 26 weeks prior to Screening
- Cerebrovascular accident within 5 years prior to Screening.
- Within 26 weeks prior to Screening: acute colic due to nephrolithiasis, or acute gout
- Participation in any other treatment 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)...
- Known allergy or sensitivity to PTH or any of the excipients [metacresol, mannitol, succinic acid, NaOH/(HCl)] of the investigational product
The study team makes the final eligibility decision.
Where it's taking place
- Reno, Nevada, United States
- New York, New York, United States
- Spokane Valley, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reno, Nevada, United States; New York, New York, United States; Spokane Valley, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.