Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism (NCT06465108) | Clinical Trial Compass
CompletedPhase 2
Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism
United States, Argentina, Turkey (Türkiye)64 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 range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
. 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