Can a pill restore calcium balance in hypoparathyroidism?
NCT ID NCT07805356
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
This phase 3 trial tests an oral drug called encaleret in about 160 adults with chronic hypoparathyroidism, a condition where the body makes too little parathyroid hormone, leading to low blood calcium and high urine calcium. Participants receive either encaleret or a placebo for 24 weeks, followed by an open-label extension where everyone can take encaleret. The study measures whether encaleret brings blood and urine calcium into a healthy target range and improves symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- encaleret
- What this could lead to
- If encaleret works, it could offer a targeted oral treatment that helps people with chronic hypoparathyroidism manage their calcium levels more naturally, potentially reducing the need for high-dose calcium and vitamin D supplements.
- What could go wrong
- This is a phase 3 trial, but it is not yet known if encaleret will outperform placebo or prove safe long-term. Some participants may experience side effects, and results may not apply to all forms of the condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2033
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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