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| ID | Type | Description | Link |
|---|---|---|---|
| R01FD007824 | U.S. FDA Grant/Contract | View source | |
| R44DK138647 | U.S. NIH Grant/Contract | View source |
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The goal of this clinical trial is to investigate the safety, tolerability and efficacy of EXT608 in adults with hypoparathyroidism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | EXT608 solution for injection, administered subcutaneously once-weekly, with multiple ascending doses (MAD) with a starting dose of 50 ug for 4 weeks, continuing to individualized dosing for 8 weeks |
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| Placebo | Placebo Comparator | Placebo solution, administered subcutaneously once-weekly, with multiple ascending doses (MAD) with a fixed dose for 4 weeks, continuing to variable dosing for 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXT608 | Drug | Modified version of parathyroid hormone attached to vitamin D to extend half-life |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of multiple subcutaneous (SC) escalating dose levels of EXT608 in participants with hypoparathyroidism by determining frequency and severity of treatment emergent adverse events and post-dose change in lab results | Frequency and severity of treatment emergent adverse events; frequency and severity of post-dose change from baseline in laboratory analyses; percentage of participants with injection site reactions | From enrollment until the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the pharmacokinetics (PK) of multiple SC doses of EXT608 given over 4 weeks in participants with hypoparathyroidism by determining Area Under the Curve (AUC) | Determine Area Under the Curve (AUC) | From enrollment until 4 weeks |
| Assess the pharmacokinetics (PK) of multiple SC doses of EXT608 given over 4 weeks in participants with hypoparathyroidism by determining drug half-life |
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Inclusion Criteria:
Exclusion Criteria:
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 homeostasis, or requiring parenteral calcium infusions.
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:
Participant has increased CV proarrhythmic potential:
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 pressures <100 and 60 mmHg, respectively).
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 efficacy in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trial Site | Recruiting | Buenos Aires | Buenos Aires F.D. | 1180AAX | Argentina |
Will be determined upon completion of the study.
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| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo |
| Other |
Placebo for injection |
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Determine drug half-life |
| From enrollment until 4 weeks |
| Assess the clinical efficacy of multiple fixed SC doses of EXT608 given over 4 weeks (at week 4), and individualized dosing after an additional 8 weeks (at week 12) in participants with hypoparathyroidism by assessing serum calcium | Proportion of participants with normal serum calcium | From enrollment until the end of treatment at 12 weeks |
| Assess the clinical efficacy of multiple fixed SC doses of EXT608 given over 4 weeks (at week 4), and individualized dosing after an additional 8 weeks (at week 12) in participants with hypoparathyroidism by assessing supplementation | Assess change from baseline of daily ingested amount of oral calcium, vitamin D supplements | From enrollment until the end of treatment at 12 weeks |