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

ACTIVE NOT RECRUITING

NCT06531941

PHASE2

Sponsor: MBX Biosciences

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-31

Completion Date

2027-05-27

Last Updated

2025-10-28

Healthy Volunteers

No

Conditions

Hypoparathyroidism

Interventions

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.