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PTH-independent Effects of Encaleret

NCT05735015 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-03-11

Study results available
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Summary

Background:

Parathyroid glands in the neck make a hormone that keeps blood calcium levels stable. Sometimes these glands are damaged or removed during neck surgery. This can lead to a condition called postsurgical hypoparathyroidism (PSH). People with PSH have low levels of calcium in their blood. Calcium and vitamin D pills can help them keep their blood calcium levels steady. But this can increase calcium in the urine and result in kidney problems. New treatments for PSH are needed.

Objective:

To test a drug (encaleret) in people with PSH.

Eligibility:

People aged 18 or older who have PSH.

Design:

Participants will be in the study for 6 months. They will have a screening visit and a treatment visit.

Screening will take up to 2 days. Participants will have a physical exam. They will have blood and urine tests and tests of their heart function. They will have an ultrasound of their kidneys; they will lie on a table for 15 to 30 minutes while a wand is moved over their back.

Treatment will require participants to stay in the clinic for 7 days and 6 nights. They will take the study drug (encaleret) by mouth twice a day for 5 days. They will have a small, flexible tube inserted into a vein; this will remain in place during the visit. Blood samples will be taken through the tube 4 to 9 times each day. Participants urine will be collected.

Participants will have follow-up blood tests one (1) week after leaving the clinic. They will have three (3) follow-up phone calls.

Conditions

  • Post-Surgical Hypoparathyroidism

Interventions

DRUG

encaleret

Encaleret 162 mg orally

Sponsors & Collaborators

  • Calcilytix Therapeutics, Inc., a BridgeBio company

    collaborator INDUSTRY

  • National Institute of Dental and Craniofacial Research (NIDCR)

    lead NIH

Principal Investigators

  • Iris R Hartley, M.D. · National Institute of Dental and Craniofacial Research (NIDCR)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-05-21
Completion
2025-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735015 on ClinicalTrials.gov