NCT06465108

Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of MBX 2109 in Patients With Hypoparathyroidism (Avail Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: MBX Biosciences · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism.

Detailed description

This study is to investigate the safety, pharmacokinetics, and efficacy of MBX 2109 administered once weekly to patients with hypoparathyroidism. Given MBX 2109 is intended as a parathyroid hormone (PTH) replacement hormone to demonstrate that MBX 2109 can maintain serum calcium within a normal range without the need for active vitamin D and therapeutic calcium supplements.

Conditions

• Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	MBX 2109	Supplied as 1.5 mg per vial reconstituted in 1.4 mL water for injection to a concentration of 1.0 mg/mL
OTHER	Placebo	Supplied in 1.4 mL water for injection

Timeline

• Start date: 2024-08-08
• Primary completion: 2025-05-23
• Completion: 2025-06-04
• First posted: 2024-06-18
• Last updated: 2026-03-20

Locations

33 sites across 3 countries: United States, Argentina, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study