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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypoparathyroidism Endocrine System Diseases Parathyroid Diseases Thyroid Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MBX Biosciences Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Screening visit:

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.

Treatment and study plan

400 µg of MBX 2109 once-weekly by subcutaneous injection

Drug

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

Drug

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.

Primary outcomes

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

Time frame: 104 weeks

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Sponsors and collaborators

Lead sponsor

MBX Biosciences

Industry

Registry information

Official study title

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)

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Aug 1, 2024
Registry last updated: Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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