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

MBX Biosciences

Status and phase: Active, not recruiting; Phase 2

Conditions: Hypoparathyroidism

Treatments: Drug: 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection; Drug: 400 µg of MBX 2109 once-weekly by subcutaneous injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06531941

MBX-2H1004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Must have completed the Week 12 Visit in MBX-2H1002 Study.

2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.

3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the

   Screening visit:

   1. Postsurgical chronic hypoparathyroidism
   2. Idiopathic hypoparathyroidism
   3. Autoimmune hypoparathyroidism

4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.

5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

400 µg once-weekly by subcutaneous injection

Experimental group

Treatment:

Drug: 400 µg of MBX 2109 once-weekly by subcutaneous injection

200-1600 µg once-weekly by subcutaneous injection

Experimental group

Treatment:

Drug: 200-1600 µg of MBX 2109 once-weekly by subcutaneous injection