Clinical trial NCT06531941: Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hypoparathyroidism
Keywords: Hypoparathyroid
Hypopara
Thyroid
MBX 2109
Lead sponsor: MBX Biosciences
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the long-term safety and tolerability of weekly MBX 2109 in patients with hypoparathyroidism.
timeFrame: 104 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: MBX Biosciences Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: MBX Biosciences Investigational Site
state: Florida
city: Macon
country: United States
facility: MBX Biosciences Investigational Site
state: Georgia
city: Jackson
country: United States
facility: MBX Biosciences Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: MBX Biosciences Investigational Site
state: Missouri
city: Omaha
country: United States
facility: MBX Biosciences Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: MBX Biosciences Investigational Site
state: Nevada
city: Reno
country: United States
facility: MBX Biosciences Investigational Site
state: Nevada
city: Albany
country: United States
facility: MBX Biosciences Investigational Site
state: New York
city: Bronx
country: United States
facility: MBX Biosciences Investigational Site
state: New York
city: Great Neck
country: United States
facility: MBX Biosciences Investigational Site
state: New York
city: Greenville
country: United States
facility: MBX Biosciences Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: MBX Biosciences Investigational Site
state: Ohio
city: Columbus
country: United States
facility: MBX Biosciences Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: MBX Biosciences Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: MBX Biosciences Investigational Site
state: Texas
city: El Paso
country: United States
facility: MBX Biosciences Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: MBX Biosciences Investigational Site
state: Texas
city: Round Rock
country: United States
facility: MBX Biosciences Investigational Site
state: Texas
city: San Antonio
country: United States
facility: MBX Biosciences Investigational Site
state: Texas
city: Weslaco
country: United States
facility: MBX Biosciences Investigational Site
state: Texas
city: Madison
country: United States
facility: MBX Biosciences Investigational Site
state: Wisconsin
Study officials:
References: