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Hormone Therapy

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 of this extension study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 104 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to assess how safe and well-tolerated MBX 2109 is in patients with hypoparathyroidism who finished a 12-week treatment period in a previous study.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to long-term use of MBX-2109 given through under-the-skin injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks 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 long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

MBX BiosciencesLead Sponsor
4 Previous Clinical Trials
240 Total Patients Enrolled
~32 spots leftby May 2027
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