A Phase 3 interventional study of Encaleret and Standard of Care in Autosomal Dominant Hypocalcemia (ADH), sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company. Active, not recruiting at 25 sites in 10 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company (part of BridgeBio) · Phase 3, Interventional, and Treatment
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).
98 studies on the registry are indexed under Hypocalcemia; 16 are open to participants now.
This study's enrollment of 67 is below the median of 84 across 66 interventional studies indexed under Hypocalcemia.
Browse Hypocalcemia studies →Calcilytix Therapeutics, Inc., a BridgeBio company is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive encaleret at a dose as needed based on calcium levels.
Drug: Encaleret
Participants will continue receiving calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)
Dietary Supplement: Standard of Care
Administered as film-coated tablet for oral use
Also known as: CLTX-305, Encaleret Sulfate
Calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)
Number of Responders who Achieve Both Albumin-Corrected Blood Calcium (cCa) and 24-hour Urinary Calcium (UCa) Within the Target Range
* 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 \[6.25 mmol/day\])
Time frame: Up to Week 24
Number of Participants With Intact Parathyroid Hormone (iPTH) Within or Greater than the Reference Range
Time frame: Up to Week 24
Number of Participants who Achieve Blood Magnesium Within the Reference Range
Time frame: Up to Week 24
Number of Participants who Achieve Blood Phosphate Within the Reference Range
Time frame: Up to Week 24
Change From Baseline in Blood 1,25-(OH)2 Vitamin D
Time frame: Baseline to Week 24
Change From Baseline in cCa
Time frame: Baseline to Week 24
Change From Baseline in 24-hour UCa
Time frame: Baseline to Week 24
Change From Baseline in iPTH
Time frame: Baseline to Week 24
Change From Baseline in Blood Phosphate and Blood Magnesium
Time frame: Baseline to Week 24
Change From Baseline in Urine Magnesium, Phosphate, Sodium, and Citrate Handling
Time frame: Baseline to Week 24
Change From Baseline in QT Interval Corrected for Changes in the Heart Rate With Fridericia Formula (QTcF) as Assessed by Electrocardiogram (ECG)
Time frame: Baseline to Week 24
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Score and Mental Component Score and Each of the Sub-Domains
Time frame: Baseline to Week 24
Number of Participants in the Encaleret Arm Receiving Calcium and/or Vitamin D Supplements
Time frame: Up to Week 24
Steady State Encaleret Trough Concentration (Ctrough)
Time frame: Up to Week 24
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Aug 2025, 31 months.
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Encaleret
Calcilytix Therapeutics, Inc., a BridgeBio company →