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

Launched by MBX BIOSCIENCES · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial is an extension study designed to assess the long-term safety and tolerability of a medication called MBX 2109 in patients with hypoparathyroidism. Hypoparathyroidism is a condition where the body doesn’t produce enough parathyroid hormone, which helps control calcium levels in the blood. This study is only for individuals who have already completed a previous 12-week treatment period in another study and are now being invited to continue.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with one of several types of hypoparathyroidism for at least six months. They should also be able to understand and agree to follow the study requirements. If you join, you can expect regular visits to monitor your health and how well you tolerate the medication over a longer period. This study is currently recruiting participants, and the aim is to ensure that MBX 2109 is safe for long-term use in individuals with this condition.

Gender

ALL

Eligibility 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.