Active — Not RecruitingPhase 2

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

United States60 participantsStarted 2024-10-31

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Must have completed the Week 12 Visit in MBX-2H1002 Study.
✓. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
✓. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
✓. Postsurgical chronic hypoparathyroidism
✓. Idiopathic hypoparathyroidism
✓. Autoimmune hypoparathyroidism
✓. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
✓. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.

What they're measuring

To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.

Timeframe: 104 weeks

Trial details

NCT IDNCT06531941

SponsorMBX Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-27

View on ClinicalTrials.gov More Hypoparathyroidism trials