encaleret
DrugOral tablets
NCT Number: NCT07805356
The aim of the study is to evaluate the efficacy, safety, and tolerability of orally administered encaleret tablets in participants with chronic hypoparathyroidism (HP).
Trial opening soon.
Get Notified16 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
For participants enrolled in study sites outside Japan:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
Oral tablets
Oral tablets
Time frame: Week 24
Time frame: Week 24
Time frame: Baseline, Week 24
Time frame: Week 24
Time frame: Week 24
Time frame: Baseline, Week 24
Time frame: Week 24
Time frame: Baseline up to Week 24
Time frame: Baseline, Week 24
Time frame: Week 20 to Week 24
Time frame: Baseline, Week 24
Time frame: Week 24
Time frame: Baseline, Week 24
Time frame: Week 24
Time frame: Week 20 to Week 24
Protocol-defined criteria which include the following: cCa within protocol-defined range, 24-hour UCa below the sex-specific upper reference limits (protocol-defined range), independence from conventional therapy, no increase in the study drug dose, and no missing active vitamin D and calcium supplementation data.
Contact information is provided by the study sponsor or research team.
Calcilytix Therapeutics, Inc., a BridgeBio company
Industry
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study With an Open-Label Extension Investigating Efficacy, Safety, and Tolerability of Encaleret in Participants With Chronic Hypoparathyroidism
Acronym: RECLAIM-HP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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