A Phase 3 interventional study of Encaleret and Placebo in Hypoparathyroidism and Chronic Hypoparathyroidism, sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company. Recruiting at 5 sites in 2 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company (part of BridgeBio) · Phase 3, Interventional, and Treatment
The aim of the study is to evaluate the efficacy, safety, and tolerability of orally administered encaleret tablets in participants with chronic hypoparathyroidism (HP).
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's planned enrollment of 160 is above the median of 50 across 77 interventional studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →Calcilytix Therapeutics, Inc., a BridgeBio company is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 4, 2026. See what changed
Key Inclusion Criteria:
For participants enrolled in study sites outside Japan:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive encaleret during the 24-week double-blind treatment period. Participants will then have the option to enter an open-label long-term extension (LTE) period to continue receiving encaleret for up to 192 weeks.
Drug: Encaleret
Participants will receive placebo during the 24-week double-blind treatment period. Participants will then have the option to enter an open-label LTE period to receive encaleret for up to 192 weeks.
Drug: Encaleret · Drug: Placebo
Oral tablets
Oral tablets
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
Change 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
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jan 2028, 17 months after the start.
Of 15 phase 3 interventional studies under Hypoparathyroidism, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 86. This study's planned 17 months is close to that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Encaleret
Calcilytix Therapeutics, Inc., a BridgeBio company →