Phase 2 Study of Weekly EXT608 Injections for Adults Aged 18-65 With Hypoparathyroidism Evaluating Safety, Tolerability, and Effectiveness Compared to Placebo

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of EXT608 in adults with hypoparathyroidism, a condition characterized by low parathyroid hormone levels affecting calcium balance. This Phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to better understand how this modified parathyroid hormone attached to vitamin D may work in this population. The study is sponsored by Extend Biosciences Inc. and focuses on adults aged 18 to 65 years who have had hypoparathyroidism for at least 12 months. Participants will receive either EXT608 or a placebo via subcutaneous injection once a week. The trial includes a multiple ascending dose phase, starting with a 50 microgram dose for 4 weeks, followed by individualized dosing for another 8 weeks. The placebo group will receive fixed doses for 4 weeks, then variable doses for 8 weeks. This dosing schedule allows researchers to assess the medications effects at different dose levels and monitor participants closely. During the 12-week treatment period, participants will be monitored for safety and tolerability through tracking of adverse events and laboratory tests. Researchers will also assess pharmacokinetics, serum calcium levels, and calcium supplementation needs. Participants will be asked to comply with study procedures, including using a smartphone diary to record medication doses and symptoms. The trial includes detailed evaluation of laboratory results and clinical outcomes to better understand the impact of EXT608 for hypoparathyroidism.

A Phase 2 Trial Investigating the Safety, Tolerability and Efficacy of EXT608 in Adults With Hypoparathyroidism