Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hy… (NCT06531941) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
United States, Argentina, Turkey (Türkiye)60 participantsStarted 2024-10-31
Plain-language 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.
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
. 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
. 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.
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 long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.