NCT06531941|Active Not RecruitingPhase 2FDA Drug

Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in 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)

MBX Biosciences ClinicalTrials.gov

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1 other identifier

MBX-2H1004

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredAug 2024

StartedOct 2024

CompletionMay 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

13mo left

Started Oct 2024

Geographic Reach

3 countries

23 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Progress59%

Oct 2024May 2027

First Submitted

Initial submission to the registry

July 16, 2024

Completed

16 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed

3 months until next milestone

Study Start

First participant enrolled

October 31, 2024

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2027

Last Updated

October 28, 2025

Status Verified

October 1, 2025

Enrollment Period

2.6 years

First QC Date

July 16, 2024

Last Update Submit

October 24, 2025

Conditions

Hypoparathyroidism

Keywords

HypoparathyroidHypoparaThyroidMBX 2109

Outcome Measures

Primary Outcomes (1)

To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
104 weeks

Study Arms (2)

400 µg once-weekly by subcutaneous injection

EXPERIMENTAL

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

200-1600 µg once-weekly by subcutaneous injection

EXPERIMENTAL

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

Interventions

400 µg of MBX 2109 once-weekly by subcutaneous injectionDRUG

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

400 µg once-weekly by subcutaneous injection

200-1600 µg of MBX 2109 once-weekly by subcutaneous injectionDRUG

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.

200-1600 µg once-weekly by subcutaneous injection

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Contact the study team to confirm eligibility.