160 Participants NeededMy employer runs this trial

Encaleret for Hypoparathyroidism

(RECLAIM-HP Trial)

Recruiting at 4 trial locations
MI
Overseen ByMedical Information
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Calcilytix Therapeutics, Inc., a BridgeBio company
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

CM

Calcilytix Medical Director

Principal Investigator

Calcilytix Therapeutics, Inc., a BridgeBio company

Are You a Good Fit for This Trial?

This trial is for people with chronic hypoparathyroidism (low parathyroid hormone) for at least 6 months. They must have stable calcium and vitamin D supplements, normal magnesium levels, and be able to stop certain water pills if needed. Genetic testing may be required for some types of the disease.

Inclusion Criteria

For participants outside Japan, elemental calcium ≥800 mg/day
I am able to understand and sign the consent form for this study.
Participants must have serum 25-hydroxy vitamin D concentration of 20 to 80 ng/mL (50-200 nmol/L)
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Exclusion Criteria

I have a genetic diagnosis of autosomal dominant hypocalcemia type 1 or 2.
I have had a seizure from low calcium in the past 3 months.
Presence or history of any disease or condition that affects safety or places participant at high risk of poor treatment compliance or study non-completion as judged by investigator
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What Are the Treatments Tested in This Trial?

Interventions

  • Encaleret

Trial Overview

The study compares encaleret tablets taken by mouth versus a placebo in people with chronic hypoparathyroidism to see how well encaleret works and how safe it is. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: EncaleretExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Calcilytix Therapeutics, Inc., a BridgeBio company

Lead Sponsor

Trials
3
Recruited
180+