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MBX 2109 for Hypoparathyroidism

Phase 2

Recruiting

Research Sponsored by MBX Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is an adult ≥18 years of age at the time of the Screening visit

If ≤25 years of age, must have radiological evidence of epiphyseal closure based on X-ray of non-dominant wrist and hand

Must not have

Is affected by active or uncontrolled disease processes that may adversely affect gastrointestinal absorption

Has a known history of pseudohyparathyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Summary

This trial aims to test how safe and well-tolerated MBX 2109 is when given once a week to patients with hypoparathyroidism.

Who is the study for?

This trial is for individuals with hypoparathyroidism. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of the condition being studied.

What is being tested?

The study tests MBX 2109's safety and how well it works compared to a placebo in people with hypoparathyroidism. It's given once weekly, and the trial likely involves regular monitoring of participants' responses to treatment.

What are the potential side effects?

While specific side effects are not listed, common ones for new treatments can include nausea, headaches, allergic reactions or injection site reactions. The study aims to identify any potential adverse effects of MBX 2109.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My growth plates in my wrist and hand have fully developed, confirmed by an X-ray.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how my body absorbs food or medicine.

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I have been diagnosed with pseudohyparathyroidism.

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I have a condition that affects my body's calcium or PTH levels.

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I had a seizure not caused by low calcium within the last 6 months.

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I have had painful kidney stones in the last 3 months.

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I had a gout flare-up within the last 2 months.

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I haven't had major surgery in the last 6 months nor plan any that could affect this study.

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I am pregnant, breastfeeding, or planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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