Efficacy, Safety, and Tolerability of Encaleret in Participants With Chronic Hypoparathyroidism

Part of paid clinical trials in Reno, Nevada.

Sponsor
Calcilytix Therapeutics, Inc., a BridgeBio company
Study ID
NCT07805356
Phase
PHASE3
Status
Recruiting
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Conditions

  • Chronic Hypoparathyroidism
  • Hypoparathyroidism

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Encaleret — DRUG
    Oral tablets
  • Placebo — DRUG
    Oral tablets

Study Details

The aim of the study is to evaluate the efficacy, safety, and tolerability of orally administered encaleret tablets in participants with chronic hypoparathyroidism (HP).

Key Dates

First listed
Sep 4, 2026
Start date
Aug 31, 2026
Status verified
Sep 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2033

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Encaleret
    Participants will receive encaleret during the 24-week double-blind treatment period. Participants will then have the option to enter an open-label long-term extension (LTE) period to continue receiving encaleret for up to 192 weeks.
  • Placebo Comparator: Placebo
    Participants will receive placebo during the 24-week double-blind treatment period. Participants will then have the option to enter an open-label LTE period to receive encaleret for up to 192 weeks.

Primary Outcome Measure

Number of Responders who Achieve Both Albumin-Corrected Blood Calcium (cCa) and 24-hour Urine Calcium (UCa) Within the Protocol-defined Target Range [ Time Frame: Week 24 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational SiteRenoNevada89511-
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational SiteGreenvilleNorth Carolina27834-
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational SiteMorehead CityNorth Carolina28557-
Calcilytix Therapeutics, Inc., a BridgeBio Company, Investigational SiteEl PasoTexas79935-

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