Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism

Description

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.

Conditions

Hypoparathyroidism

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Study Overview

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Study Details

Study overview

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.

An Extension Study 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 Study (Avail-Ext)

Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism

Condition
Hypoparathyroidism
Intervention / Treatment

-

Contacts and Locations

Jacksonville

MBX Biosciences Investigational Site, Jacksonville, Florida, United States, 32204

Jacksonville

MBX Biosciences Investigational Site, Jacksonville, Florida, United States, 32216

Macon

MBX Biosciences Investigational Site, Macon, Georgia, United States, 31210

Jackson

MBX Biosciences Investigational Site, Jackson, Mississippi, United States, 39202

Saint Louis

MBX Biosciences Investigational Site, Saint Louis, Missouri, United States, 63110

Omaha

MBX Biosciences Investigational Site, Omaha, Nebraska, United States, 68198

Las Vegas

MBX Biosciences Investigational Site, Las Vegas, Nevada, United States, 89148

Reno

MBX Biosciences Investigational Site, Reno, Nevada, United States, 89511

Albany

MBX Biosciences Investigational Site, Albany, New York, United States, 12203

Bronx

MBX Biosciences Investigational Site, Bronx, New York, United States, 10467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Must have completed the Week 12 Visit in MBX-2H1002 Study.
  • 2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
  • 3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
  • 1. Postsurgical chronic hypoparathyroidism
  • 2. Idiopathic hypoparathyroidism
  • 3. Autoimmune hypoparathyroidism
  • 4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
  • 5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MBX Biosciences,

Study Record Dates

2027-05-27