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NCT06465108 (MBX2109 in Hypoparathyroidism): BVCT ex-ante prediction vs. reported outcome

On 1 Jun 2025, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 22 Sep 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically borderline significant and commercially probably insufficient (inferior to eneboparatide).

Clinical Trial

NCTID
NCT06465108
Acronym
Avail
Drug Name
MBX2109 (Canvuparatide)
Drug MoA
long-acting PTH prodrug
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Endocrine System Diseases
Indication
Hypoparathyroidism
Human Patients
64
Sponsor
MBX Biosciences
Phase
Phase 2

Prediction of , index 2029

Prospective Prediction
Prediction Index
2029
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit to SoC in the composite endpoint moderately inferior to eneboparatide)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit to SoC in the composite endpoint compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
113 days in advance
Readout Data Interpretation
Canvuparatide achieved 63% response rate at week 12 (32% placebo-adjusted response rate p=0.042) in the composite primary endpoint (normal-ranged ADsCa maintenance and independence from conventional therapy); moderately inferior to eneboparatide that achieved 88% response rate at week 12 in the same composite primary endpoint (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically borderline significant and commercially probably insufficient (inferior to eneboparatide)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of MBX 2109 in Patients With Hypoparathyroidism (Avail Study)
Phase
Phase 2
Status
Completed
Enrollment
64
Lead sponsor
MBX Biosciences
Conditions
Hypoparathyroidism
Interventions
DRUG: MBX 2109; OTHER: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2024-08-08
Primary completion
2025-05-23
Completion
2025-06-04
Primary outcomes
  • To evaluate the effect of pooled weekly doses of MBX 2109 on the proportion of responder patients defined by serum calcium levels and treatment with active vitamin D and calcium supplements at Week 12/Visit 15 (Week 12)

NCT06465108 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials