Canvuparatide vs placebo in adults with hypoparathyroidism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, controlled trial evaluating canvuparatide as a once-weekly treatment for adult patients with hypoparathyroidism. Participants are assigned to receive either canvuparatide or placebo to assess efficacy and safety over the course of the study. Eligible adults have chronic hypoparathyroidism with specific calcium and PTH criteria and stable mineral supplementation. Key safety assessments include routine blood tests and monitoring for calcium-phosphate balance. The trial is sponsored by MBX Biosciences and conducted at three investigational sites in the United States.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Is an adult ≥18 years of age.
2. Has a documented diagnosis of post-surgical, chronic HypoPT or genetic, idiopathic, or autoimmune HypoPT for at least 12 months prior to screening.
3. Intact PTH level below the median value of the normal range
4. Minimum requirement for a dose of calcitriol ≥0.5 μg/day, or alfacalcidol ≥1.0 μg/day and (elemental) calcium ≥1000 mg/day for at least 12 weeks prior to screening. In addition, the doses of calcitriol, or alfacalcidol, and calcium should be stable for at least 3 weeks prior to screening.
5. Two (2) consecutive measurements of albumin-adjusted serum calcium at least 1 week apart within the range of 7.8 to 9.4 mg/dL (1.95 to 2.35 mmol/L).

Key Exclusion Criteria:

1. Has a known history of pseudohypoparathyroidism
2. Clinically significant abnormal hematology, clinical chemistry, or coagulation.
3. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HypoPT, such as active endogenous hyperthyroidism;
4. Use of therapies affecting the calcium metabolism within 4 weeks prior to randomization
5. PTH or PTH-related protein drugs such as PTH(1-84) and PTH(1-34) within 5 weeks prior to screening.

Where it's running

• MBX Biosciences Investigational Site
  Englewood, Colorado, United States Recruiting
• MBX Biosciences Investigational Site
  Homestead, Florida, United States Recruiting
• MBX Biosciences Investigational Site
  Lawrenceville, Georgia, United States Recruiting
• MBX Biosciences Investigational Site
  Metairie, Louisiana, United States Recruiting
• MBX Biosciences Investigational Site
  Jackson, Mississippi, United States Recruiting
• MBX Biosciences Investigational Site
  Omaha, Nebraska, United States Recruiting

Study contacts

• Study coordinator: Salomon Azoulay, MD
• Phone: 13176590200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• German Hypoparathyroidism Registry

  This registry in Germany collects information from adults with chronic hypoparathyroidism or pseudohypoparathyroidism to better understand how the condition affects people over time and to support future research.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857460

• Encaleret for Chronic Hypoparathyroidism: Testing if it helps symptoms and safety

  This study tests whether taking encaleret pills can help people with chronic hypoparathyroidism, while being safe and tolerable.

  Recruiting at 5 sites Phase 3 Calcilytix Therapeutics, Inc., a BridgeBio company · Reno, Nevada and 4 other locations · NCT07805356

• Palopegteriparatide in adolescents with long-term hypoparathyroidism

  This study tests whether a once-daily palopegteriparatide shot helps adolescents with long‑standing hypoparathyroidism and whether it’s safe for them.

  Recruiting at 3 sites Phase 3 Ascendis Pharma A/S · Bron and 2 other locations · NCT07706764

• NIRAF-guided identification of parathyroids during thyroidectomy

  A wearable near-infrared autofluorescence device is being tested to help surgeons find and protect the parathyroid glands during thyroid surgery in adults.

  Recruiting Ss. Cyril and Methodius University of Skopje · Skopje · NCT07617584

• Pregnancy registry tracking outcomes after YORVIPATH exposure during pregnancy and breastfeeding

  This registry collects information from pregnant or breastfeeding people with hypoparathyroidism who took YORVIPATH to see if the exposure affects pregnancy, the baby, or infant outcomes through the first year of life.

  Recruiting Ascendis Pharma A/S · Morgantown, West Virginia · NCT07345494

• Palopegteriparatide levels in breast milk of lactating individuals taking YORVIPATH.

  This will see if palopegteriparatide (YORVIPATH) appears in the breast milk of lactating adults with hypoparathyroidism who are breastfeeding.

  Recruiting Ascendis Pharma A/S · Morgantown, West Virginia · NCT07264634

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.