NCT07699471 A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism
| NCT ID | NCT07699471 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | MBX Biosciences |
| Condition | Hypoparathyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-08 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2026-08 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to investigate the efficacy and safety of canvuparatide administered as a once-weekly (QW) treatment to adult study participants with hypoparathyroidism (HypoPT).
Eligibility Criteria
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.
Contact & Investigator
Salomon Azoulay, MD
📞 13176590200
Frequently Asked Questions
Who can join the NCT07699471 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypoparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07699471 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT07699471 currently recruiting?
Yes, NCT07699471 is actively recruiting participants. Visit ClinicalTrials.gov or contact MBX Biosciences to inquire about joining.
Where is the NCT07699471 trial being conducted?
This trial is being conducted at Homestead, United States, Metairie, United States, Las Vegas, United States, Reno, United States and 8 additional locations.
Who is sponsoring the NCT07699471 clinical trial?
NCT07699471 is sponsored by MBX Biosciences. The trial plans to enroll 160 participants.