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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Primary outcome measure(s)

• To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism. — 104 weeks
  Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Trial sites (23)