NCT05680818

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

CALIBRATE: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Calcilytix Therapeutics, Inc., a BridgeBio company · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.)

Timeline

• Start date: 2023-01-06
• Primary completion: 2025-08-22
• Completion: 2029-08-01
• First posted: 2023-01-11
• Last updated: 2025-10-31

Locations

25 sites across 10 countries: United States, Australia, Canada, Czechia, Denmark, France, Italy, Japan, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study