Can a pill restore calcium balance in hypoparathyroidism?

NCT ID NCT07805356

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2033

An estimate. End dates often move.

Lead sponsor

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

16 years and older

Sex

Anyone

Healthy volunteers

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

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

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  2. The official record

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Contacts and locations

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