← Back to Search

Calcium-sensing receptor antagonist

Encaleret for Hypocalcemia (CALIBRATE Trial)

Phase 3
Recruiting
Research Sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 24
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new medication called encaleret for people with a rare genetic condition known as ADH1. ADH1 causes low calcium levels, and current treatments may not be effective or safe enough. Encaleret aims to help by balancing calcium levels in the blood.

Who is the study for?
This trial is for people with a genetic variant causing hypoparathyroidism (ADH1), aged 16-18 with closed growth plates, not on certain diuretics or supplements, and meeting specific treatment criteria. Excluded are those recently on PTH treatments, had seizures or thyroid surgery, pregnant/nursing women, low Vitamin D levels, certain viral infections, or severely reduced kidney function.
What is being tested?
The study aims to compare the effectiveness and safety of encaleret against standard care in treating ADH1. Participants will receive either encaleret or the usual treatment without knowing which one they're getting to measure differences in health outcomes.
What are the potential side effects?
While the side effects of encaleret aren't detailed here, common reactions to new medications may include nausea, headaches, allergic reactions or skin rashes. The trial will monitor participants closely for any adverse effects that arise during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Responders who Achieve Both Albumin-Corrected Blood Calcium (cCa) and 24-hour Urinary Calcium (UCa) Within the Target Range

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of Care (SoC)Experimental Treatment1 Intervention
Participants will continue receiving calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)
Group II: EncaleretExperimental Treatment1 Intervention
Participants will receive encaleret at a dose as needed based on calcium levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420
Encaleret
2020
Completed Phase 2
~20

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Calcium-sensing receptor (CaSR) antagonists like Encaleret treat hypocalcemia by inhibiting CaSR in the parathyroid gland, leading to increased secretion of parathyroid hormone (PTH). PTH raises calcium levels by enhancing kidney reabsorption, bone resorption, and intestinal absorption of calcium. Other treatments include calcium supplements and vitamin D analogs, which directly increase serum calcium and improve gut absorption. These mechanisms are crucial for hypocalcemia patients to prevent symptoms like muscle cramps, tetany, and cardiac issues, thereby improving their quality of life.

Find a Location

Who is running the clinical trial?

Calcilytix Therapeutics, Inc., a BridgeBio companyLead Sponsor
2 Previous Clinical Trials
108 Total Patients Enrolled
Calcilytix Medical DirectorStudy DirectorCalcilytix Therapeutics, Inc., a BridgeBio company
2 Previous Clinical Trials
108 Total Patients Enrolled

Media Library

Encaleret (Calcium-sensing receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05680818 — Phase 3
Familial hypocalciuric hypercalcemia Research Study Groups: Standard of Care (SoC), Encaleret
Familial hypocalciuric hypercalcemia Clinical Trial 2023: Encaleret Highlights & Side Effects. Trial Name: NCT05680818 — Phase 3
Encaleret (Calcium-sensing receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05680818 — Phase 3
~7 spots leftby Apr 2025