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NCT05680818 (Encaleret in Autosomal Dominant Hypocalcemia Type 1): BVCT ex-ante prediction vs. reported outcome

On 26 Jan 2025, BioinvestGPT's BVCT predicted technical partial success and commercial partial failure for this trial. The 29 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably insufficient.

Clinical Trial

NCTID
NCT05680818
Acronym
CALIBRATE
Drug Name
Encaleret
Drug MoA
CaSR antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Endocrine System Diseases
Indication
Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Human Patients
67
Sponsor
BridgeBio Pharma
Phase
Phase 3

Prediction of , index 1150

Prospective Prediction
Prediction Index
1150
Prediction Date
Commercial Prediction
partial FAILURE (commercially maybe sufficient yet very weak clinical benefit in QTcF/SF36 non-superior to SoC)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit in cCa/24-hr UCa at most numerically superior to SoC yet with a negative dose-response relationship)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
276 days in advance
Readout Data Interpretation
encaleret achieved superiority in the primary endpoint of the proportion of participants achieving both normal cCa and normal 24-hr UCa at week 24 compared with standard-of-care treatments (76% vs 4% p<0.0001); yet encaleret failed to achieve superiority in key efficacy endpoints such as QTcF or SF-36 (data not disclosed)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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)
Phase
Phase 3
Status
Active not recruiting
Enrollment
67
Lead sponsor
Calcilytix Therapeutics, Inc., a BridgeBio company
Conditions
Autosomal Dominant Hypocalcemia (ADH)
Interventions
DRUG: Encaleret; DIETARY_SUPPLEMENT: Standard of Care
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-01-06
Primary completion
2025-08-22
Completion
2029-08
Primary outcomes
  • Number of Responders who Achieve Both Albumin-Corrected Blood Calcium (cCa) and 24-hour Urinary Calcium (UCa) Within the Target Range (Up to Week 24)

NCT05680818 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials