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

PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 31, 2024

Primary Completion Date

May 27, 2027

Study Completion Date

May 27, 2027

Conditions
Hypoparathyroidism
Interventions
DRUG

400 µg of MBX 2109 once-weekly by subcutaneous injection

"Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL.~Patients who received Placebo in the Phase 2 MBX-2H1002 study, will initiate treatment with 400 µg subcutaneous MBX 2109 once-weekly"

DRUG

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

"Supplied as 1.5 mg per vial, to be reconstituted in 1.4 mL water for injection (diluent) to a concentration of 1.0 mg/mL.~Patients treated with MBX 2109 in the Phase 2 MBX-2H1002 study will continue at the screening visit in the extension study on the same dose they were receiving at the Week 11 Visit in Study MBX-2H1002.~The maximum allowed dose is 1600 μg weekly administered subcutaneously in the abdomen, rotating injection sites. Doses of MBX 2109 study drug greater than 1000 μg will be administered subcutaneously in two separate, equal injections."

Trial Locations (22)

10021

RECRUITING

MBX Biosciences Investigational Site, Great Neck

10467

RECRUITING

MBX Biosciences Investigational Site, The Bronx

12203

RECRUITING

MBX Biosciences Investigational Site, Albany

19107

RECRUITING

MBX Biosciences Investigational Site, Philadelphia

27834

RECRUITING

MBX Biosciences Investigational Site, Greenville

31210

RECRUITING

MBX Biosciences Investigational Site, Macon

32204

RECRUITING

MBX Biosciences Investigational Site, Jacksonville

32216

RECRUITING

MBX Biosciences Investigational Site, Jacksonville

39202

RECRUITING

MBX Biosciences Investigational Site, Jackson

43201

RECRUITING

MBX Biosciences Investigational Site, Columbus

44195

RECRUITING

MBX Biosciences Investigational Site, Cleveland

53705

RECRUITING

MBX Biosciences Investigational Site, Madison

63110

RECRUITING

MBX Biosciences Investigational Site, St Louis

68198

RECRUITING

MBX Biosciences Investigational Site, Omaha

75208

RECRUITING

MBX Biosciences Investigational Site, Dallas

76132

RECRUITING

MBX Biosciences Investigational Site, Fort Worth

78231

RECRUITING

MBX Biosciences Investigational Site, San Antonio

78596

RECRUITING

MBX Biosciences Investigational Site, Weslaco

78681

RECRUITING

MBX Biosciences Investigational Site, Round Rock

79935

RECRUITING

MBX Biosciences Investigational Site, El Paso

89148

RECRUITING

MBX Biosciences Investigational Site, Las Vegas

89511

RECRUITING

MBX Biosciences Investigational Site, Reno

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MBX Biosciences

INDUSTRY

NCT06531941 - Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism | Biotech Hunter | Biotech Hunter