MBX 2109 for Hypoparathyroidism
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: MBX Biosciences
Disqualifiers: Others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
How is the drug MBX 2109 different from other treatments for hypoparathyroidism?
MBX 2109 is unique because it may offer a new approach to treating hypoparathyroidism, which traditionally relies on calcium and vitamin D supplements that can lead to complications. Unlike these supplements, MBX 2109 could potentially address the underlying hormone deficiency, similar to recombinant human PTH 1-84, which is used for patients not well controlled on standard therapy.
12345Eligibility Criteria
This trial is for adults over 18 with hypoparathyroidism (post-surgical, idiopathic, or autoimmune) diagnosed for at least half a year. Participants must have finished a previous 12-week Phase 2 study of MBX-2109 and be able to self-administer the drug after proper demonstration.Inclusion Criteria
I have been diagnosed with a specific type of low parathyroid hormone for over 6 months.
Must have completed the Week 12 Visit in MBX-2H1002 Study
I am 18 years old or older.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive MBX 2109 once weekly to evaluate long-term safety and tolerability
104 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial tests the long-term safety and tolerability of MBX-2109 in patients with hypoparathyroidism. It involves weekly subcutaneous injections ranging from 200 to 1600 µg, following up on an earlier phase study.
2Treatment groups
Experimental Treatment
Group I: 400 µg once-weekly by subcutaneous injectionExperimental Treatment1 Intervention
Group II: 200-1600 µg once-weekly by subcutaneous injectionExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MBX Biosciences Investigational SiteMacon, GA
MBX Biosciences Investigational SiteSan Antonio, TX
MBX Biosciences Investigational SiteGreenville, NC
MBX Biosciences Investigational SiteDallas, TX
More Trial Locations
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Who Is Running the Clinical Trial?
MBX BiosciencesLead Sponsor
References
Therapy of Hypoparathyroidism With rhPTH(1-84): A Prospective, 8-Year Investigation of Efficacy and Safety. [2020]Conventional treatment of hypoparathyroidism is associated with decreased renal function and increased bone mineral density (BMD).
The Epidemiology of Hypoparathyroidism in Italy: An 8-Year Register-Based Study. [2018]Hypoparathyroidism is a rare endocrine disorder, but few studies have focused on the epidemiology and hospital management of the disease and none has been performed in Italy. We investigated the prevalence of different forms of hypoparathyroidism among hospitalized patients in Italy during an 8-year period. This study is designed as a retrospective register-based study. We retrieved data from the "Record of Hospital Discharge" (SDO) of the Italian Health Ministry, from the year 2006 to 2013 and analyzed the codes corresponding to hypoparathyroidism-related diagnoses. The inpatient prevalence of the disease was also calculated after excluding repeated hospitalizations. Overall, 27,692 hospitalization episodes for hypoparathyroidism were identified during the entire period (72.2% in women and 27.8% in men; mean age 49.5 ± 22.9 years). The mean length of stay was 7.4 ± 9.8 days (25.9% of the episodes requiring less than 3 days of stay). The mean hospitalization rate for hypoparathyroidism was 5.9/100,000 inhabitants per year and there was a significant decrease during the period of 2006-2013 (p
Quality of life in patients with hypoparathyroidism receiving standard treatment: a systematic review. [2018]Hypoparathyroidism is a rare endocrine disorder for which replacement therapy of the missing parathyroid hormone is not the standard therapeutic option. Current standard treatment consists of calcium and vitamin D supplementation. The intake of calcium and vitamin D supplementation can lead to complications and therefore might negatively influence patients' quality of life.
Review of Hypoparathyroidism. [2019]Hypoparathyroidism is a rare endocrine disorder in which parathyroid hormone (PTH) production is abnormally low or absent, resulting in low serum calcium and increased serum phosphorus. The most common cause of hypoparathyroidism is parathyroid gland injury or inadvertent removal during thyroid surgery. Current treatments include supplementation with calcium and active vitamin D, with goal albumin-corrected serum calcium level in the low-normal range of 8-9 mg/dl. Complications of the disease include renal dysfunction, nephrocalcinosis, kidney stones, extracellular calcifications of the basal ganglia, and posterior subcapsular cataracts, as well as low bone turnover and increased bone density. Until January 2015, hypoparathyroidism was the only classic endocrine disease without an available hormone replacement. Recombinant human PTH 1-84, full-length PTH, is now available for a selected group of patients with the disease who are not well controlled on the current standard therapy of calcium and active vitamin D. In addition, the role of PTH replacement on quality of life, intracerebral calcifications, cataracts, improving bone turnover, and reduction of renal complications of the disease remains to be further investigated.
Defining the Characteristics of Chronic Hypoparathyroidism Not Adequately Controlled on Conventional Therapy: Consensus Findings of Three European Delphi Panels. [2020]European Society of Endocrinology (ESE) guidelines provide goals for hypoparathyroidism management but do not define characteristics of chronic hypoparathyroidism that is not adequately controlled. Three European country-specific Delphi panels were conducted to gain consensus on these characteristics.