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A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

Study acronym: Tumor HI
StatusRecruiting
PhasePhase 3
SponsorRezolute
Started
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Record History

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  1. Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 1 of 13 sites
  2. Site details revised at 1 of 13 sitesv12
  3. Site details revised at 2 of 13 sitesv11
  4. Site details revised at 1 of 13 sitesv10
  5. Site details revised at 1 of 13 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 2 of 13 sitesv8
  2. Study sites: 4 to 13v7
  3. Enrollment target: 48 to 16v6 Show 7 more changesShow less
    • Primary endpoints: 2 to 1
    • Interventions: Ersodetug (Drug), Ersodetug (Drug), Placebo (Drug) to Ersodetug (Drug)
    • Eligibility criteria shortened, about 110 words
    • Secondary endpoints: 4 to 3
    • Study description shortened, about 103 words
    • Study title revised
    • Study arms: 2 to 1
  4. Study sites: 3 to 4v5
  5. Study sites: 2 to 3v4
  6. Study sites: 1 to 2v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2025 to Apr 16, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Rezolute
3 trials monitored
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Pancreatic Cancer
1,739 trials monitored
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Sarcoma
1,026 trials monitored
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The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI).
Trial Details
NCT Number NCT06881992
Lead Sponsor Rezolute
Conditions
(from sponsor)		 Tumor Hyperinsulinism (Tumor HI)
Related terms Adenoma, Islet Cell, Fibrosarcoma, Hyperinsulinism, Hypoglycemia, Insulinoma, Liposarcoma, Neoplasms, Neuroectodermal Tumors, Primitive, Neuroendocrine Tumors
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov