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NCT Number: NCT07805356

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

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • Calcitriol ≥0.5 micrograms (μg)/day or alfacalcidol ≥1.0 μg/day
  • 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.

Treatment and study plan

encaleret

Drug

Oral tablets

Placebo

Drug

Oral tablets

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants With cCa Within Protocol-defined Range

    Time frame: Week 24

  2. Change From Baseline to Week 24 in cCa

    Time frame: Baseline, Week 24

  3. Absolute Value of cCa at Week 24

    Time frame: Week 24

  4. Number of Participants With 24-hour UCa Below the Sex-specific Upper Reference Limits (Protocol-defined Range)

    Time frame: Week 24

  5. Change from Baseline to Week 24 in 24-hour UCa

    Time frame: Baseline, Week 24

  6. Absolute Value of 24-hour UCa at Week 24

    Time frame: Week 24

  7. 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

  8. 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

  9. Number of Participants With Calcium Independence

    Time frame: Week 20 to Week 24

  10. Change from Baseline in Signs and Symptoms of Hypoparathyroidism, Based on Participants' Responses

    Time frame: Baseline, Week 24

  11. 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

  12. 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

  13. Number of Participants Who Meet the Primary Endpoint (Biochemical Response) and Has Active Vitamin D Independence

    Time frame: Week 24

  14. Number of Participants Who Meet Specific Protocol-defined Criteria or Calcium and Vitamin D Analysis

    Time frame: Week 20 to Week 24

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

650-600-3610

Sponsors and collaborators

Lead sponsor

Calcilytix Therapeutics, Inc., a BridgeBio company

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Investigating Efficacy, Safety, and Tolerability of Encaleret in Participants With Chronic Hypoparathyroidism

Acronym: RECLAIM-HP

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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