A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rezolute
Study ID
NCT06881992
Phase
PHASE3
Status
Recruiting
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Conditions

  • Tumor Hyperinsulinism (Tumor HI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ersodetug — DRUG
    Ersodetug (9 mg/kg) + SOC

Study Details

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).

Key Dates

Start date
Apr 16, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)

Primary Outcome Measure

Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline. [ Time Frame: 8 weeks ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Investigative SiteChicagoIllinois60637-
Investigative SiteBethesdaMaryland20892-
Investigative SiteBostonMassachusetts02114-
Investigative SiteRochesterMinnesota55905-
Investigative SiteNew YorkNew York10021-
Investigative SiteCantonOhio44718-
Investigative SitePortlandOregon97239-
Investigative SiteHoustonTexas77030-

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