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Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1

NCT05680818 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-10-31

No results posted yet for this study

Summary

The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).

Conditions

  • Autosomal Dominant Hypocalcemia (ADH)

Interventions

DRUG

Encaleret

Administered as film-coated tablet for oral use

DIETARY_SUPPLEMENT

Standard of Care

Calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)

Sponsors & Collaborators

  • Calcilytix Therapeutics, Inc., a BridgeBio company

    lead INDUSTRY

Principal Investigators

  • Calcilytix Medical Director · Calcilytix Therapeutics, Inc., a BridgeBio company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2025-08-22
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Denmark
  • France
  • Italy
  • Japan
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05680818 on ClinicalTrials.gov