Health TrialsbyHealthPanel

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

ConditionsHypoparathyroidismChronic Hypoparathyroidism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorCalcilytix Therapeutics, Inc., a BridgeBio company

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Encaleret

    Drug

    Oral tablets

  • Placebo

    Drug

    Oral tablets

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: EncaleretExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Calcilytix Therapeutics, Inc., a BridgeBio company

Lead sponsor

Source ClinicalTrials.gov
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