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Clinical Trials in the USA / NCT07805356
Recruiting Phase 3

Efficacy, Safety, and Tolerability of Encaleret in Participants With Chronic Hypoparathyroidism

NCT07805356 · tracked via the Priya Life Science USA tracker
Sponsor
Calcilytix Therapeutics, Inc., a BridgeBio company
Phase
Phase 3
Started
2026-08-31
Last updated
2026-09-16

Condition(s) studied

HypoparathyroidismChronic Hypoparathyroidism

Investigational drug(s) / intervention(s)

EncaleretPlacebo

Encaleret: Oral tablets

Placebo: Oral tablets

Study summary

The aim of the study is to evaluate the efficacy, safety, and tolerability of orally administered encaleret tablets in participants with chronic hypoparathyroidism (HP).

Eligibility

Sex
ALL
Min age
16 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Participants must have had a clinically confirmed diagnosis of chronic HP, with disease duration of at least 26 weeks prior to screening. Cause of chronic HP can be postsurgical, autoimmune or idiopathic. * For participants with nonsurgical chronic HP etiology, sufficient documentation that the participant does not harbor any variants in calcium-sensing receptor (CASR) or GNA11 that are classified as pathogenic, likely pathogenic, or of uncertain significance, with the exception of benign common polymorphisms (CASR A986S and R990G) is needed. * Participants must be on stable doses of calcium and active vitamin D supplementation at or above the following minimum thresholds for at least 6 weeks prior to screening. For participants enrolled in study sites outside Japan: 1. Calcitriol ≥0.5 micrograms (μg)/day or alfacalcidol ≥1.0 μg/day 2. Elemental calcium ≥800 milligrams (mg)/day (for example, calcium citrate, calcium carbonate) * Participants must meet the following criteria during screening: cCa within 7.8 to 9.5 mg/deciliter (dL) and 24-hour UCa ≥300 mg/day (males) or ≥250 mg/day (females). * Participants have serum 25-hydroxy (OH) vitamin D concentration of 20 to 80 nanograms (ng)/milliliter (mL) (50-200 nanomoles \[nmol\]/liter \[L\]). * Participants have serum magnesium concentration within the reference range. * Participants on thiazide or loop diuretics must be able to discontinue them during the first 24 weeks of study (treatment). * Participants must be capable of giving signed informed consent or assent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. Key Exclusion Criteria: * Genetically confirmed diagnosis of autosomal dominant hypocalcemia type 1 (ADH1) or autosomal dominant hypocalcemia type 2 (ADH2) due to activating variants in CASR or GNA11, respectively. * History of hypocalcemic seizure in the 3 months prior to screening. * History of cancer (except non-melanoma skin cancer) or bone metastases in the 5 years prior to screening. * Prior skeletal irradiation, chemotherapy with alkylating agents, or diagnosis of Paget's disease, fibrous dysplasia, chronic osteomyelitis, bone infarcts, benign bone tumors with curettage and grafting, retinoblastoma, or Li-Fraumeni syndrome. * Presence or history of any disease or condition (for example, drug or alcohol dependence) that, in the view of the investigator, would affect the participant's safety or places the participant at high risk of poor treatment compliance or of not completing the study. Other protocol-defined inclusion/exclusion criteria apply.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site Reno Nevada Recruiting
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site Greenville North Carolina Recruiting
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site Morehead City North Carolina Recruiting
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site El Paso Texas Recruiting
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational Site Oakville Ontario Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07805356 on ClinicalTrials.gov ↗ ← All trials in the USA