NCT06208215 (sunRIZE) is a Phase 3 clinical trial of RZ358 (5-10 mg/kg) + SOC in Congenital Hyperinsulinism, sponsored by Rezolute.

Who is sponsoring NCT06208215?

NCT06208215 is sponsored by Rezolute.

What drugs are being tested in NCT06208215?

Interventions in NCT06208215: RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC, RZ358 (10 mg/kg) or Placebo + SOC, RZ358 (5-10 mg/kg) + SOC.

What condition does NCT06208215 study?

NCT06208215 studies Congenital Hyperinsulinism.

Is NCT06208215 still recruiting?

NCT06208215 is currently active, enrolled. Last updated 8 January 2026.

Last reviewed 2026-01-08 · How we verify

NCT06208215: sunRIZE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

RZ358 Treatment for Congenital Hyperinsulinism

Active, enrolled Phase 3 Last updated 8 January 2026

What this trial tests

Phase 3 trial testing RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC in Congenital Hyperinsulinism in 56 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 January 2024

Primary endpoint
14 November 2025

14 November 2027

Quick facts

Lead sponsor	Rezolute
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	56
Start date	11 January 2024
Primary completion	14 November 2025
Estimated completion	14 November 2027
Sites	18 locations across Georgia, Denmark, France, Greece, United Kingdom, Germany, Vietnam, Oman

Drugs / interventions tested

RZ358 (5 mg/kg) + SOC (Standard-of-Care) or Placebo + SOC — full drug profile →
RZ358 (10 mg/kg) or Placebo + SOC — full drug profile →
RZ358 (5-10 mg/kg) + SOC — full drug profile →

Conditions studied

Congenital Hyperinsulinism — all drugs for Congenital Hyperinsulinism →

Sponsor

Rezolute — full company profile →

Who can join

Adults 3 Months to 45, any sex, with Congenital Hyperinsulinism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2025.
Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538
Antibodies to watch in 2026.
Crescioli S, Kaplon H, Chenoweth A, Hsu YS, et al · · 2026 · PMID 41560619 · DOI 10.1080/19420862.2026.2614669

Verify or expand the search:

Other recruiting trials for Congenital Hyperinsulinism

Currently open trials in the same condition.

NCT04732416 — HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI) · Phase 2 · recruiting
NCT03941236 — Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism · Phase 3 · active not recruiting
NCT04205604 — 18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism · Phase 2 · recruiting

Other Rezolute trials

Trials by the same sponsor.

NCT05712720 — Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME) · Phase 2 · completed
NCT04538989 — An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism · Phase 2 · completed
NCT07262970 — Intermediate-Size Cohort EAP for Ersodetug in Patients With Inadequately Controlled Hypoglycemia Related to a Tumor · available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06208215 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rezolute
Last refreshed: 8 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06208215.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing