Encaleret for Hypoparathyroidism

(RECLAIM-HP Trial)

This trial tests a new treatment called encaleret for individuals with chronic hypoparathyroidism (HP), a condition where the body produces too little parathyroid hormone, leading to low calcium levels. Researchers aim to assess the effectiveness and safety of encaleret compared to a placebo (a pill with no active medicine). Those who have had HP for at least six months and regularly rely on calcium and vitamin D supplements might be suitable for this study. Participants will initially receive treatment for 24 weeks and may choose to continue for a longer period. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Research has shown that encaleret is generally safe and well tolerated. Previous studies found that it functions in the body as expected. For example, in one study, all participants taking encaleret reported improvements in symptoms similar to those of hypoparathyroidism. This suggests that people typically handle the treatment well, with no unexpected issues. Although the treatment remains under study, these findings provide some reassurance about its current safety.¹²³⁴⁵

Unlike the standard treatments for hypoparathyroidism, which often involve calcium and vitamin D supplements, Encaleret offers a new approach by directly targeting the calcium-sensing receptor. This mechanism allows for better regulation of calcium levels in the body, potentially reducing the need for high doses of supplements. Researchers are excited about Encaleret because it could offer a more balanced and effective way to manage calcium levels with fewer side effects, improving the quality of life for patients with hypoparathyroidism.

Studies have shown that encaleret can help manage conditions related to calcium in the body. One study found that encaleret significantly reduced the amount of calcium in urine over 24 hours, which is important for maintaining balanced calcium levels. Research also shows that 76% of patients treated with encaleret reached the desired calcium levels in both blood and urine, compared to only 4% of those on standard treatments. Additionally, encaleret helped many participants return to normal calcium levels in their urine without causing serious side effects. These findings suggest that encaleret could be a promising treatment for managing hypoparathyroidism. Participants in this trial will receive either encaleret or a placebo during the 24-week double-blind treatment period, with the option to continue with encaleret in an open-label long-term extension period.⁶⁷⁸⁹¹⁰