RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2024-10-31
Study Completion:2027-05-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06531941

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must have completed the Week 12 Visit in MBX-2H1002 Study.
  2. 2. Is an adult ≥18 years of age at the time of the Screening visit of this extension study.
  3. 3. Has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the
  4. 1. Postsurgical chronic hypoparathyroidism
  5. 2. Idiopathic hypoparathyroidism
  6. 3. Autoimmune hypoparathyroidism
  7. 4. Can comprehend and is willing to sign an informed consent form (ICF), and abide by the study restrictions, study visits, and procedures.
  8. 5. In the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Salomon Azoulay, MD
CONTACT
844-877-4473
MBX2109.Clinicaltrials@mbxbio.com
Kristi Schneider, RN, ANP-BC
CONTACT
844-877-4473
MBX2109.Clinicaltrials@mbxbio.com

Study Locations (Sites)

MBX Biosciences Investigational Site
Jacksonville, Florida, 32204
United States
MBX Biosciences Investigational Site
Jacksonville, Florida, 32216
United States
MBX Biosciences Investigational Site
Macon, Georgia, 31210
United States
MBX Biosciences Investigational Site
Jackson, Mississippi, 39202
United States
MBX Biosciences Investigational Site
Saint Louis, Missouri, 63110
United States
MBX Biosciences Investigational Site
Omaha, Nebraska, 68198
United States
MBX Biosciences Investigational Site
Las Vegas, Nevada, 89148
United States
MBX Biosciences Investigational Site
Reno, Nevada, 89511
United States
MBX Biosciences Investigational Site
Albany, New York, 12203
United States
MBX Biosciences Investigational Site
Bronx, New York, 10467
United States
MBX Biosciences Investigational Site
Great Neck, New York, 10021
United States
MBX Biosciences Investigational Site
Greenville, North Carolina, 27834
United States
MBX Biosciences Investigational Site
Cleveland, Ohio, 44195
United States
MBX Biosciences Investigational Site
Columbus, Ohio, 43201
United States
MBX Biosciences Investigational Site
Philadelphia, Pennsylvania, 19107
United States
MBX Biosciences Investigational Site
Dallas, Texas, 75208
United States
MBX Biosciences Investigational Site
El Paso, Texas, 79935
United States
MBX Biosciences Investigational Site
Fort Worth, Texas, 76132
United States
MBX Biosciences Investigational Site
Round Rock, Texas, 78681
United States
MBX Biosciences Investigational Site
San Antonio, Texas, 78231
United States
MBX Biosciences Investigational Site
Weslaco, Texas, 78596
United States
MBX Biosciences Investigational Site
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: MBX Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31
Study Completion Date2027-05-27

Study Record Updates

Study Start Date2024-10-31
Study Completion Date2027-05-27

Terms related to this study

Keywords Provided by Researchers

  • Hypoparathyroid
  • Hypopara
  • Thyroid
  • MBX 2109

Additional Relevant MeSH Terms

  • Hypoparathyroidism