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Long-term evaluation of MBX 2109 for patients with hypoparathyroidism

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)

Phase 2 Interventional MBX Biosciences · NCT06531941

This study is testing a weekly injection of MBX 2109 to see if it can help people with hypoparathyroidism keep their calcium levels normal without relying on vitamin D or too many calcium supplements.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment48 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorMBX Biosciences Industry-sponsored
Locations22 sites (Jacksonville, Florida and 21 other locations)
Trial IDNCT06531941 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term safety and tolerability of MBX 2109, administered once weekly via subcutaneous injection, in patients with hypoparathyroidism who have previously completed a 12-week treatment period. The focus is on maintaining normal serum calcium levels without the need for active vitamin D and reducing calcium supplement intake. Participants will be monitored for their ability to self-administer the medication and adhere to study protocols.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have completed the prior study and have a diagnosis of chronic, idiopathic, or autoimmune hypoparathyroidism.

Not a fit: Patients who have not completed the prior study or those with other forms of hypoparathyroidism may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the management of hypoparathyroidism by reducing reliance on vitamin D and calcium supplements.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this area.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Jacksonville, Florida and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HypoparathyroidismHypoparathyroidHypoparaThyroidMBX 2109
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.