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NCT05680818 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
A Phase 3 study of Autosomal Dominant Hypocalcemia (ADH), sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company.
- Active
- Registry status
- Phase 3
- Development phase
- 67
- Enrollment target
- 20
- Study locations
NCT05680818: Active Phase 3 study of Autosomal Dominant Hypocalcemia (ADH), sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company.
NCT05680818 is a Phase 3 study of Autosomal Dominant Hypocalcemia (ADH) that is active but no longer recruiting, run by Calcilytix Therapeutics, Inc., a BridgeBio company. The registered enrollment target is 67 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05680818, a Phase 3 study of Autosomal Dominant Hypocalcemia (ADH), is active but no longer recruiting, sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 67 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
* cCa within 8.3-10.7 mg/dL (2.08-2.68 millimoles per liter \[mmol/L\]) * 24-hr UCa within the reference range (\< 300 mg/day for men \[7.5 mmol/day\], \< 250 mg/day for women \[6.25 mmol/day\])
Conditions Studied
Interventions
- DRUG Encaleret
- DIETARY_SUPPLEMENT Standard of Care
Study Locations (20)
Other
- Vseobecna fakultni nemocnice v Praze - New Town
- Aarhus University Hospital - Aarhus
- Hôpital Edouard Herriot - HCL - Lyon
- IRCCS Ospedale San Raffaele - Milan
- University Hospital of Pisa - Pisa
California
- UCSF Benioff Children's Hospital, Oakland - Oakland
Colorado
- Children's Hospital Colorado - Aurora
Indiana
- Indiana University Health University Hospital - Indianapolis
Maryland
- NIH - Bethesda
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Mayo Clinic - Rochester - Rochester
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2023-01-06 |
| Est. Completion | 2029-08 |
| Phase | Phase 3 |
What the registry record for NCT05680818 still lists
NCT05680818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Autosomal Dominant Hypocalcemia (ADH) appearing as the primary indexed condition, and to 2 interventions - of which Encaleret is the first listed.
NCT05680818 names 20 study sites across 16 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05680818 about?
NCT05680818 is a clinical study titled "Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1". 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).
What is the current status of trial NCT05680818?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2023-01-06. Estimated completion is 2029-08.
What conditions does trial NCT05680818 study?
This clinical trial studies the following conditions: Autosomal Dominant Hypocalcemia (ADH).
What interventions are being tested in trial NCT05680818?
The interventions under investigation include: Encaleret (DRUG), Standard of Care (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05680818?
This trial is sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05680818 being conducted?
This trial has 20 study locations across California, Colorado, Indiana, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05680818's enrollment target sits among peer trials
67 1797th of 2000 higher than 204 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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