Loading clinical trials...

Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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)

NCT05680818•Calcilytix Therapeutics, Inc., a BridgeBio company

View on ClinicalTrials.gov

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).

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants must have a documented pathogenic or likely pathogenic activating variant, or variant of uncertain significance, of the calcium sensing receptor (CASR) gene associated with biochemical findings of hypoparathyroidism.
•2. Participants must have a documented history of symptoms or signs of ADH1.
•3. Participants 16 to \<18 years old must have closed growth plates on hand radiograph.
•4. Participants treated with thiazide diuretics must discontinue thiazides for at least 14 days prior to SoC Optimization Visit 1 through Week 24 (Period 3). When the thiazide is being used as an antihypertensive, alternative therapy will be prescribed by the Investigator as needed.
•5. Participants treated with phosphate binders (other than calcium salts) must discontinue the phosphate binders at least one day prior to the SoC Optimization Visit 1.
•6. Participants treated with magnesium or potassium supplements must be willing to discontinue such treatment prior to the first dose of encaleret.
•7. Participants treated with potassium-sparing diuretics must be willing to discontinue such treatment prior to the first dose of encaleret.
•8. Participants must meet SoC Optimization criteria as defined in the protocol.

Exclusion Criteria

•1. History of hypocalcemic seizure within the past 3 months preceding Screening.
•2. History of thyroid or parathyroid surgery.
•3. History of renal transplantation.
•4. Pregnant or nursing (lactating) women, where pregnancy is confirmed by a positive beta-human chorionic gonadotropin (β-hCG) laboratory test.
•5. History of treatment with parathyroid hormone (PTH) 1-84 or 1-34 within the 2 months preceding Screening and requiring SoC doses exceeding \>1.2× their pre-PTH treatment total daily doses or bone turnover markers, Collagen cross-linked C-telopeptide (CTx )and Procollagen type 1 N-propeptide (P1NP), \> upper limit of normal for sex, age (men only) and menopausal status (women only).
•6. Blood 25-OH Vitamin D level \<25 nanograms (ng)/milliliter (mL).
•7. Estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m\^2 using chronic kidney disease-EPI creatinine equation refit without the race variable (chronic kidney disease-EPI creatinine equation refit without the race variable \[CKD-EPIcr\_R\]) (for participants \<18 years old the Bedside Schwartz equation should be used).
•8. Participants with positive Hepatitis B surface antigen (HBsAg), Hepatitis A immunoglobulin M (IgM), or human immunodeficiency virus (HIV) viral serology test at the Screening Visit. Participants who are in complete remission from Hepatitis C virus (HCV) as evidenced by sensitive assay ≥12 weeks after completion of HCV therapy may participate in the study.

Locations (25)

UCSF Benioff Children's Hospital, Oakland

Oakland, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

NIH

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

Physicians East

Greenville, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

January 6, 2023

Primary Completion Date

August 22, 2025

Completion Date

August 1, 2029

Last Updated

October 31, 2025

Enrollment

ACTUAL participants

Conditions

Autosomal Dominant Hypocalcemia (ADH)

Interventions

Encaleret

DRUG

Standard of Care

DIETARY_SUPPLEMENT

Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1

NCT04581629

Autosomal Dominant Hypocalcemia (ADH)Autosomal Dominant Hypocalcemia Type 1 (ADH1)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions