The aim of the study is to evaluate the efficacy, safety, and tolerability of orally administered encaleret tablets in participants with chronic hypoparathyroidism (HP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site
Reno, Nevada, United States
RECRUITINGCalcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site
Greenville, North Carolina, United States
RECRUITINGCalcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site
Morehead City, North Carolina, United States
Number of Responders who Achieve Both Albumin-Corrected Blood Calcium (cCa) and 24-hour Urine Calcium (UCa) Within the Protocol-defined Target Range
Time frame: Week 24
Number of Participants With cCa Within Protocol-defined Range
Time frame: Week 24
Change From Baseline to Week 24 in cCa
Time frame: Baseline, Week 24
Absolute Value of cCa at Week 24
Time frame: Week 24
Number of Participants With 24-hour UCa Below the Sex-specific Upper Reference Limits (Protocol-defined Range)
Time frame: Week 24
Change from Baseline to Week 24 in 24-hour UCa
Time frame: Baseline, Week 24
Absolute Value of 24-hour UCa at Week 24
Time frame: Week 24
Number of Participants Who Meet the Primary Endpoint (Biochemical Response) and Have a Reduction From Baseline in Calcium Supplements Dose
Time frame: Baseline up to Week 24
Percent Change From Baseline to Week 24 in Daily Intake of Calcium Supplements Among the Participants Who Meet the Primary Endpoint (Biochemical Response)
Time frame: Baseline, Week 24
Number of Participants With Calcium Independence
Time frame: Week 20 to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site
El Paso, Texas, United States
RECRUITINGCalcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site
Oakville, Ontario, Canada
RECRUITINGChange from Baseline in Signs and Symptoms of Hypoparathyroidism, Based on Participants' Responses
Time frame: Baseline, Week 24
Number of Participants Who Meet the Primary Endpoint (Biochemical Response) and Have a Reduction From Baseline in Active Vitamin D Dose
Time frame: Week 24
Percent Change From Baseline in Daily Intake of Active Vitamin D Among the Participants Who Meet the Primary Endpoint (Biochemical Response)
Time frame: Baseline, Week 24
Number of Participants Who Meet the Primary Endpoint (Biochemical Response) and Has Active Vitamin D Independence
Time frame: Week 24
Number of Participants Who Meet Specific Protocol-defined Criteria or Calcium and Vitamin D Analysis
Protocol-defined criteria which include the following: cCa within protocol-defined range, 24-hour UCa below the sex-specific upper reference limits (protocol-defined range), independence from conventional therapy, no increase in the study drug dose, and no missing active vitamin D and calcium supplementation data.
Time frame: Week 20 to Week 24