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Tests treatment safety and results for Hypoparathyroidism
Official title A Phase 2 Trial Investigating the Safety, Tolerability and Efficacy of EXT608 in Adults With Hypoparathyroidism
ClinicalTrials.gov ID: NCT06988670
What this study is testing
What is EXT608?
EXT608 is an investigational medicine, being studied as a potential treatment for hypoparathyroidism.
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
- The goal of this clinical trial is to investigate the safety, tolerability and efficacy of EXT608 in adults with hypoparathyroidism.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Ability to personally provide written, signed, and dated informed consent to participate in the study.
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Male or female between 18 and 65 years of age. Male participants with female partners of child bearing potential must agree to use barrier...
- Participants have a history of hypoparathyroidism for 12 months at least, with PTH levels below the LLN with concomitant serum calcium \< 9 mg/dL.
- Participants are treated with a daily dose \> 750 mg elemental calcium if using \> 0.25 µg/day calcitriol, or a daily dose \> 1000 mg elemental...
You likely can't join if
- Participants with hypoparathyroidism due to an activating mutation of the calcium sensing receptor, pseudohypoparathyroidism, any...
- Unwillingness to use a diary deployed on a smartphone daily for recording vitamin D, active vitamin D, calcium, magnesium and study drug doses as...
- Participants with a history of neoplasia (except thyroid cancer) with no sign of recurrence 5 years after diagnosis.
- Participants with a history of or active GI tract disease that may impact the absorption of calcium (e.g. malabsorption).
- Participants with a history of severe hypocalcemia leading to seizures or cardiac arrhythmias within 6 months prior to screening.
- Participants with chronic kidney disease (eGFR \< 30 ml/min) or active nephrolithiasis (needing pain medication in the last 6 months).
See the full eligibility criteria
- Ability to personally provide written, signed, and dated informed consent to participate in the study.
- An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- Male or female between 18 and 65 years of age. Male participants with female partners of child bearing potential must agree to use barrier contraception, e.g., condoms plus spermicide, from administration of the study...
- Participants have a history of hypoparathyroidism for 12 months at least, with PTH levels below the LLN with concomitant serum calcium \< 9 mg/dL.
- Participants are treated with a daily dose \> 750 mg elemental calcium if using \> 0.25 µg/day calcitriol, or a daily dose \> 1000 mg elemental calcium if not using calcitriol.
- Participants have normal blood levels of 25-hydroxyvitamin D (i.e. \> 20 ng/dL or \> 75 nmol/L) and not above 1.5 times the upper limit of normal.
- Participants have normal thyroid test results for 3 months at least while taking a stable dose of thyroid medication or no medication.
- Participants have a BMI \< 35 kg/m2.
- Albumin-adjusted serum calcium level should be between the lower half and the middle of the normal range upon randomization into the study.
- Participants with hypoparathyroidism due to an activating mutation of the calcium sensing receptor, pseudohypoparathyroidism, any non-hypoparathyroidism disease that may affect calcium metabolism or phosphor-calcium...
- Unwillingness to use a diary deployed on a smartphone daily for recording vitamin D, active vitamin D, calcium, magnesium and study drug doses as well as periodic symptom reporting.
- Participants with a history of neoplasia (except thyroid cancer) with no sign of recurrence 5 years after diagnosis.
- Participants with a history of or active GI tract disease that may impact the absorption of calcium (e.g. malabsorption).
- Participants with a history of severe hypocalcemia leading to seizures or cardiac arrhythmias within 6 months prior to screening.
- Participants with chronic kidney disease (eGFR \< 30 ml/min) or active nephrolithiasis (needing pain medication in the last 6 months).
- Participants taking the following medications within the respective exclusion period:
- Proton pump inhibitors (4 weeks)
- Bisphosphonates (3 months)
- Parathyroid hormone, PTH analogs (6 months)
- Thiazide diuretics (14 days)
- Calcitonin or calcinet hydrochloride (3 months)
- Participant has increased CV proarrhythmic potential:
- Participant has a QT interval with Fridericia's correction method (QTcF) \>450 ms or PR outside the range of 120 to 220 ms, confirmed with one repeat testing, at the Screening Visit or Inpatient Check-in (Day -1) Visit.
- A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- The use of concomitant medications that prolong the QT/QTc interval.
- Chronic/severe cardiac disease including, but not limited to, cardiac insufficiency, unstable angina, arrhythmias, bradycardia (resting heart rate \<60 beats/minute), or hypotension (systolic and diastolic blood...
- Any condition or disease that, in the opinion of the investigator, may interfere with a participant's participation or may confound the interpretation of safety or how well it works in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Buenos Aires F.D., Argentina
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Buenos Aires F.D., Argentina. 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.