CompletedPhase 2

Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism

United States64 participantsStarted 2024-08-08

Plain-language summary

The purpose of this study is to investigate the safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Is an adult ≥18 years of age at the time of the Screening visit.
✓. 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 (e.g., isolated autoimmune hypoparathyroidism; stable, well-managed patients with autoimmune polyglandular syndrome type 1/autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy without current or past malabsorption at the discretion of the principal investigator \[PI\])
✓. On a dose for at least 4 weeks prior to the Screening visit of the following:
✓. Calcitriol ≥0.5 µg per day or alfacalcidol ≥1 ug per day (active vitamin D)
✓. Elemental calcium (citrate or carbonate) supplement ≥800 mg per day

Exclusion criteria

✕. Has a known history of pseudohypoparathyroidism (impaired responsiveness to PTH, which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia).
✕. Has any disease (other than hypoparathyroidism) that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels (e.g., disorders of the calcium sensing receptor \[e.g., autosomal dominant hypocalcemia type 1\] are exclusionary).
✕. Use any of the following therapies:
✕. Loop diuretics, thiazide diuretics, phosphate binders (other than calcium carbonate or citrate), digoxin, lithium, methotrexate, raloxifene hydrocholoride, or acute systemic corticosteroids within 4 weeks prior to the Screening Visit;
✕. PTH or PTH-related protein drugs such as PTH(1-84) and PTH(1-34) within 4 weeks of the Screening visit;
✕. Oral or intravenous bisphosphonates, denosumab, or romosozumab-aqqg within 18 months of the Screening visit; or
✕. Other drugs known to influence calcium and bone metabolism such as calcitonin, fluoride tablets (\>0.5 mg per day), strontium or cinacalcet hydrochloride within 3 months of the Screening visit.
✕. Had a non-hypocalcemic seizure within 6 months of the Screening visit. Note: a history of seizures that occur in the setting of hypocalcemia is not exclusionary

What they're measuring

To evaluate the effect of pooled weekly doses of MBX 2109 on the proportion of responder patients defined by serum calcium levels and treatment with active vitamin D and calcium supplements at Week 12/Visit 15

Timeframe: Week 12

Trial details

NCT IDNCT06465108

SponsorMBX Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-23

View on ClinicalTrials.gov More Hypoparathyroidism trials