NCT06531941

Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism

An Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism Who Completed the 12-Week Treatment Period in the Phase 2 Study, MBX-2H1002 Study (Avail-Ext)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: MBX Biosciences · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of MBX 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the Phase 2 study, MBX-2H1002.

Detailed description

This study is to investigate the long-term safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism. Additionally, the ability of MBX 2109 to maintain serum calcium levels within the normal range without the need for active vitamin D and to reduce elemental calcium supplements to ≤600 mg/day.

Conditions

• Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	400 µg of MBX 2109 once-weekly by subcutaneous injection	Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL. Patients who received Placebo in the Phase 2 MBX-2H1002 study, will initiate treatment with 400 µg subcutaneous MBX 2109 once-weekly
DRUG	200-1600 µg of MBX 2109 once-weekly by subcutaneous injection	Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL. Patients treated with MBX 2109 in the Phase 2 MBX-2H1002 study will continue at the screening visit in the extension study on the same dose they were receiving at the Week 11 Visit in Study MBX-2H1002. The maximum allowed dose is 1600 μg weekly administered subcutaneously in the abdomen, rotating injection sites. Doses of MBX 2109 study drug greater than 1000 μg will be administered subcutaneously in two separate, equal injections.

Timeline

• Start date: 2024-10-31
• Primary completion: 2027-05-27
• Completion: 2027-05-27
• First posted: 2024-08-01
• Last updated: 2025-10-28

Locations

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

Regulatory

• FDA-regulated drug study