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

Last updated: November 11, 2024
Sponsor: MBX Biosciences
Overall Status: Active - Recruiting

Phase

2

Condition

Hypoparathyroidism

Treatment

400 µg of MBX 2109 once-weekly by subcutaneous injection

200-1600 µg of MBX 2109 once-weekly by subcutaneous injection

600 µg of MBX 2109 once-weekly by subcutaneous injection

Clinical Study ID

NCT06531941
MBX-2H1004
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion 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

Screening visit:

  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.

Study Design

Total Participants: 48
Treatment Group(s): 4
Primary Treatment: 400 µg of MBX 2109 once-weekly by subcutaneous injection
Phase: 2
Study Start date:
October 31, 2024
Estimated Completion Date:
May 27, 2027

Study Description

This study is to investigate the long-term safety and tolerability of MBX 2109 administered once weekly to patients with hypoparathyroidism. Additionally, the ability of MBX 2109 to maintain serum calcium levels within the normal range without the need for active vitamin D and to reduce elemental calcium supplements to ≤600 mg/day.

Connect with a study center

  • MBX Biosciences Investigational Site

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Macon, Georgia 31210
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Jackson, Mississippi 39202
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Reno, Nevada 89511
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Albany, New York 12203
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Bronx, New York 10467
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Great Neck, New York 10021
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Columbus, Ohio 43201
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Dallas, Texas 75208
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    El Paso, Texas 79935
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Fort Worth, Texas 76132
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    San Antonio, Texas 78231
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Weslaco, Texas 78596
    United States

    Active - Recruiting

  • MBX Biosciences Investigational Site

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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