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Phase 1/2RecruitingNCT06524960

Denosumab for beta-cell function in T1D

What this study tests

Randomized phase 1/2 study of denosumab versus placebo in T1D diagnosed 1–5 years previously, testing adverse events and residual beta-cell function over 12 months. No results are posted.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-07-28.

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Females 18–50 and males 21–50 with T1D diagnosed 12 months to 5 years before screening, an islet autoantibody, and nonfasting C-peptide at least 0.2 nmol/L confirmed on mixed-meal testing. Normal calcium and other safety criteria apply; see registry. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results posted yet.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Treatment-related adverse events through12months
  • Change in mixed-meal C-peptide AUC from baseline to12months versus placebo

The full picture

This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.

Sources

  1. [1]