RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), PRIME (European Union)

Structure/Sequence

Sequence Code 719971371L

Source: *****

Sequence Code 719971495H

Source: *****

Clinical Trials associated with Ersodetug

NCT06881992

/ RecruitingPhase 3

A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)

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).

Start Date16 Apr 2025

Sponsor / Collaborator

Rezolute, Inc.

NCT06208215

/ Active, not recruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study to Evaluate the Efficacy and Safety of RZ358 in Patients With Congenital Hyperinsulinism

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.

Start Date11 Jan 2024

Sponsor / Collaborator

Rezolute, Inc.

NCT04538989

/ CompletedPhase 2

An Open-Label Multiple-Dose Study of RZ358 in Patients With Congenital Hyperinsulinism

The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).

Start Date24 Feb 2020

Sponsor / Collaborator

Rezolute, Inc.

100 Clinical Results associated with Ersodetug

100 Translational Medicine associated with Ersodetug

100 Patents (Medical) associated with Ersodetug

Literatures (Medical) associated with Ersodetug

01 Jun 2025·Med

Global, multi-center, repeat-dose, phase 2 study of RZ358 (ersodetug), an insulin receptor antibody, for congenital hyperinsulinism

Article

Author: Melikyan, Maria ; Roberts, Brian K ; Demirbilek, Huseyin ; Mohnike, Klaus ; Galcheva, Sonya ; O'Boyle, Erin ; Dastamani, Antonia ; Christesen, Henrik Thybo ; Kheladze, Nino ; Thornton, Paul S ; Empting, Susann ; Iotova, Violeta ; Clemente, Maria ; De Leon, Diva D ; Mazor-Aronovitch, Kineret ; Hood, Davelyn ; Ozbek, Mehmet Nuri

BACKGROUND:

Congenital hyperinsulinism (cHI) is a rare, primarily pediatric disease characterized by dysregulated insulin secretion resulting in severe, persistent hypoglycemia, frequently leading to lifelong neurologic impairments. The safety, pharmacokinetics, and glycemic efficacy of ersodetug, a fully human monoclonal antibody that allosterically and reversibly binds the insulin receptor (INSR) and reduces excess insulin action, are being evaluated for the treatment of cHI-related hypoglycemia.

METHODS:

A global, open-label, phase 2b study (ClinicalTrials.gov: NCT04538989) was conducted in 23 patients with cHI with persistent hypoglycemia on standard-of-care (SOC) therapies. Eligible participants (age ≥2 years) received add-on ersodetug at dose levels between 3 and 9 mg/kg intravenously (i.v.) bi-weekly for 8 weeks in 4 sequential dose cohorts.

FINDINGS:

Enrolled participants (average age = 6.7 years) on SOC (87% medications; 17% previous pancreatectomy) experienced 13 events/week and 23% time in hypoglycemia at baseline. Ersodetug resulted in predictable, dose-proportional pharmacokinetics. No deaths, adverse drug reactions, study withdrawals, or dose-limiting toxicities occurred. Hypoglycemia (<70 mg/dL) events (self-monitored blood glucose) and time (continuous glucose monitoring) improved from baseline by medians of 59% (p < 0.001) and 54% (p < 0.001), respectively, across pooled dose levels and by 48%-84% (events) and 61%-65% (time) at doses of 6 or 9 mg/kg (p < 0.05) with a nearly universal individual patient response rate. Additional hypoglycemia metrics, including overnight hypoglycemia, similarly improved.

CONCLUSION:

Ersodetug was generally well tolerated and significantly improved hypoglycemia in participants with cHI. Ersodetug represents a novel INSR-targeted mechanism of action with the potential to be an effective therapy for all forms of cHI, alone or in combination with other therapies.

FUNDING:

Rezolute, Inc. (Redwood City, CA), provided funds.

01 Aug 2017·The Journal of clinical endocrinology and metabolismQ2 · MEDICINE

Attenuation of Insulin Action by an Allosteric Insulin Receptor Antibody in Healthy Volunteers

Q2 · MEDICINE

Article

Author: Bezwada, Padma ; Johnson, Kirk W ; Rubin, Paul ; Neale, Ann ; Roessig, Julie ; Gordon, Allan ; Goldfine, Ira ; Vukelich, Sabine

Background:

XOMA 358 (X358) is a fully human monoclonal antibody to the insulin receptor that acts as a negative allosteric modulator of insulin signaling. It is being developed as a novel treatment of hyperinsulinemic hypoglycemia. This report describes pharmacokinetic (PK) and pharmacodynamic (PD) data from a first-in-human clinical trial.

Methods:

A double-blind, placebo-controlled, single-ascending-dose study was performed with 29 healthy adult males randomized to intravenous infusion of placebo or X358 at 0.1-, 0.3-, 1-, 3-, 6-, or 9-mg/kg dose levels. The primary objective was to assess safety and tolerability, and secondary objectives included PK and PD analyses. A short insulin tolerance test (ITT) was implemented in the 3- to 9-mg/kg dose cohorts at baseline and postinfusion.

Results:

There were no deaths, serious adverse events (AEs), or subject discontinuations due to AEs. There were no clinically meaningful safety findings. X358 exhibited dose-proportional PK with a half-life of 21 days. Dose-dependent elevations of circulating insulin levels, likely related to reduced insulin clearance via monoclonal antibody action at receptors, represented a sensitive biomarker of X358 exposure. X358-dependent increases in postprandial glucose levels and fasting homeostatic model assessment of insulin resistance values were observed and persisted for at least 1 week at the higher dose levels. In all the ITT cohorts, the slope for glucose lowering was substantially attenuated after X358 infusion of a similar magnitude, but with increasing duration with rising dose level.

Conclusion:

Single X358 infusions were well tolerated and resulted in a dose-dependent reduction in insulin sensitivity. Clinical development of X358 in hyperinsulinemic, hypoglycemic conditions is proceeding.

News (Medical) associated with Ersodetug

07 Jan 2026

·www.biospace.com

Rezolute Provides Insights from its Phase 3 sunRIZE Study in Congenital Hyperinsulinism and Shares Findings from its Expanded Access Program in Tumor Hyperinsulinism

Company believes that data from sunRIZE and the Expanded Access Program (EAP) provide evidence of activity of ersodetug in both indications Company plans to meet with FDA to align on path forward for congenital HI REDWOOD CITY, Calif., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), today shared observations from the Phase 3 sunRIZE study in patients with congenital HI and provided details on the treatment of tumor HI patients with ersodetug under the Company’s EAP. Congenital HI While sunRIZE did not meet its primary (hypoglycemia events) or key secondary (time in hypoglycemia) endpoints, the Company believes that the totality of the data further supports previous clinical evidence that ersodetug is active against hypoglycemia in patients. Specifically, there was evidence of pharmacologic activity as target therapeutic drug concentrations were achieved in both treatment groups (5 mg/kg and 10 mg/kg) with highly sensitive biomarker responses (increases in circulating insulin) in the active treatment groups that are indicative of reduced insulin activity at its receptor. Notably, these responses were consistent with those of the Company’s Phase 2 RIZE study (see Figure 1). The study also demonstrated reductions from baseline in events and time in hypoglycemia in both treatment groups, but not enough to be statistically significant compared to the pronounced study effect in the placebo arm. While in the early stages of evaluating study data and understanding the results, learnings in the field of glycemic control and initial observations from sunRIZE inform the Company’s belief that the pharmacologic response can translate to clinical efficacy. The magnitude of the placebo response observed for hypoglycemia events reveals a significant challenge in studying glucose in an ambulatory setting, where factors such as intensive monitoring where caregivers receive alerts regarding hypoglycemic events and frequent clinical interactions can independently influence outcomes. The Company believes that the extent of reduction from baseline in hypoglycemia events and time in hypoglycemia relative to placebo (see Figure 2) may have been impacted by the prolonged treatment duration of six months and the fact that glucose monitoring is necessary for safe patient management while also serving as the key endpoint in the study. This sentiment has been shared with the Company by investigator physicians as well as study participants. The Company is currently exploring how to characterize the overall study dynamic including evaluating patient-reported quality of life outcomes. In light of these limitations, assessing the potential benefit in the ongoing open-label extension (OLE) portion of the study will be important. All 59 participants who completed the study elected to continue to receive ersodetug in the OLE. To date, 57 participants remain in the OLE, with an exposure duration ranging from ~6 weeks for the most recently entered patients, to ~18 months. The Company believes that a potential indicator of ersodetug’s underlying efficacy is that several children in the OLE have been able to stop taking all other therapies and are now receiving ersodetug as monotherapy. The Company looks forward to interacting with FDA in Q1 2026 under its Breakthrough Therapy Designation to further characterize these and other clinical outcomes to inform a review of the full sunRIZE dataset with the intent of exploring options for this indication. Tumor HI Over the past two years, Rezolute has collaborated with investigators across the United States and in Europe to provide ersodetug to more than a dozen patients with severe and refractory hypoglycemia due to tumor HI, including malignant pancreatic neuroendocrine tumors (insulinomas) and non-islet cell tumors. The Company has previously reported that the therapy was generally well-tolerated, and that patients experienced substantial improvement in hypoglycemia, which led to a reduction in the rate of glucose infusion in the hospital (GIR) or the complete discontinuation of infusion and discharge from the hospital. Presented in a table filed today on Form 8-K with the U.S. Securities and Exchange Commission are cumulative data from the initial 9 participants in the EAP, including patient characteristics, ersodetug dosing, and observed outcomes. This same data cohort was provided to FDA last year in support of the Company’s request for Breakthrough Therapy Designation and subsequently informed the discussion with FDA that led to revision of the Phase 3 upLIFT study in tumor HI to a single arm, open-label study. In summary, 75% of the patients receiving IV dextrose/total parental nutrition (TPN) in the EAP achieved a complete discontinuation of IV dextrose/TPN. This outcome is highly relevant to the ongoing upLIFT study and provides additional evidence of the activity and potential efficacy of ersodetug across various forms of HI. Notably, the GIR assessment in the EAP is the primary endpoint in upLIFT, which measures the number of participants (out of ~16) who achieve at least a 50% reduction in GIR, an objective endpoint in a highly controlled hospital setting. For statistical significance, 9 of 16 open-label participants need to achieve this threshold. Topline results are anticipated in the second half of 2026. About sunRIZE The Phase 3 sunRIZE study (RZ358-301) was a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital hyperinsulinism (HI), ages 3 months to 45 years old, who were experiencing continued hypoglycemia on currently available standard of care (SOC). Eligible participants were randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control as add on to existing SOC. Study drug was administered every other week during an initial loading phase, and then every 4 weeks during the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants could roll-over into an optional open-label extension phase to continue to receive ersodetug. The study enrolled 63 participants in more than a dozen countries around the world, inclusive of U.S. patients. The primary and key secondary efficacy endpoints in the study were the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia, respectively, over six months of treatment. About Ersodetug Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI. About Rezolute, Inc. Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has been studied in clinical trials and used in real-world cases for the treatment of both congenital and tumor HI. For more information, visit . Forward-Looking Statements This release, like many written and oral communications presented by Rezolute and our authorized officers, may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of Rezolute, are generally identified by use of words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "project," "seek," "strive," "try," or future or conditional verbs such as "could," "may," "should," "will," "would," or similar expressions. These forward-looking statements include, but are not limited to, the potential efficacy of ersodetug in treating hypoglycemia associated with either congenital or tumor HI, the possibility of FDA agreeing to a streamlined path for advancing the congenital HI program notwithstanding the lack of statistical significance in the sunRIZE study, or the timing of the release of topline results for upLIFT. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, Rezolute undertakes no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made. Important factors that may cause such a difference include any other factors discussed in our filings with the SEC, including the Risk Factors contained in Rezolute’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available at the U.S. Securities and Exchange Commission’s website at You are urged to consider these factors carefully in evaluating the forward-looking statements in this release and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. Rezolute Contacts: Christen Baglaneas cbaglaneas@rezolutebio.com 508-272-6717 Carrie McKim cmckim@rezolutebio.com 336-608-9706 Figures accompanying this announcement are available at:

Phase 3Clinical ResultPhase 2Breakthrough Therapy

14 Dec 2025

·www.globenewswire.com

Rezolute Announces Phase 3 sunRIZE Study Results in Congenital Hyperinsulinism

Study did not meet the primary or key secondary endpoint 45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40% improvement in placebo arm Management to host conference call today at 8:30am ET Dec. 11, 2025 -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced topline results from its Phase 3 sunRIZE study evaluating ersodetug in patients with congenital hyperinsulinism (HI). The study did not meet its primary endpoint, which assessed change in the average weekly hypoglycemia events by self monitored blood glucose. There was an approximate 45% reduction in hypoglycemia events observed at the top ersodetug dose (10 mg/kg), which was not statistically significant compared to the placebo group, which experienced a 40% improvement. Furthermore, the study did not meet its key secondary endpoint, which assessed change in average daily percent time in hypoglycemia by continuous glucose monitoring (CGM). At the 10 mg/kg dose of ersodetug, an approximate 25% reduction in time in hypoglycemia was observed, which was not statistically significant compared to the placebo, which increased by approximately 5%. At the study dose regimens of 5 and 10 mg/kg administered every other week for 3 doses, followed by every 4 weeks over the remainder of the 24-week treatment duration, ersodetug target drug concentrations were achieved, across all age groups studied. Safety observations from the study were generally favorable and, in the opinion of the Company, support safe use of ersodetug in pediatric and adult patients. Two of the study participants experienced serious hypersensitivity reactions which led to early discontinuation of study drug. The incidence of serious allergic reactions across the program is relatively low compared to biologic or monoclonal antibody treatments. The most commonly reported study adverse event in ersodetug treated participants compared to placebo was hypertrichosis, which was generally mild and self-limiting. “We are disappointed that the study did not demonstrate significant improvements in glucose-related endpoints relative to placebo as well as for the patients and families living with congenital HI who urgently need new treatment options,” said Brian Roberts, M.D., Chief Medical Officer of Rezolute. “At the same time, there are aspects of the results that merit additional investigation, and we are conducting a thorough evaluation to gain a better understanding of the study outcomes, which will inform our path forward. We intend to meet with FDA under our Breakthrough Therapy Designation to consider next steps for the program. We are deeply grateful to the patients and families, the majority of whom have continued into the open label extension part of the study, as well as to the investigators and site teams who participated in this important study.” The Phase 3 upLIFT study for tumor HI is ongoing with topline results expected in the second half of 2026. To access the event by phone, please dial 1-877-317-6789 from the U.S. and Canada or 1-412-317-6789 internationally and ask to be joined into the Rezolute call. The live webcast can be accessed on the investor page of Rezolute’s website at https://ir.rezolutebio.com. The Phase 3 sunRIZE study (RZ358-301) is a multi-center, randomized, double-blind, placebo-controlled, parallel arm study designed to evaluate the efficacy and safety of ersodetug in patients with congenital hyperinsulinism (HI), ages 3 months to 45 years old, who are experiencing continued hypoglycemia on currently available standard of care (SOC). Eligible participants are randomized to one of three treatment arms to receive either ersodetug (5 or 10 mg/kg) or matched placebo-control as add on to existing SOC. Study drug is administered every other week during an initial loading phase, and then every 4 weeks during the 6-month controlled pivotal treatment period. Following the pivotal treatment phase of the study, participants may roll-over into an optional open-label extension phase to continue to receive ersodetug. The study enrolled 63 participants in more than a dozen countries around the world, inclusive of U.S. patients. The primary and key secondary efficacy endpoints in the study are the change from baseline in the average number of hypoglycemia events per week and the average percent time in hypoglycemia, respectively, over six months of treatment. Ersodetug is a fully human monoclonal antibody that binds allosterically to the insulin receptor to decrease receptor over-activation by insulin and related substances (such as IGF-2) in the setting of hyperinsulinism (HI), thereby improving hypoglycemia. Because ersodetug acts downstream from the pancreas, it has the potential to be universally effective at treating hypoglycemia due to any congenital or acquired form of HI. Rezolute is a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism (HI). The Company’s antibody therapy, ersodetug, is designed to treat all forms of HI and has shown meaningful benefit in clinical trials and real-world use. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultBreakthrough Therapy

11 Dec 2025

·www.fiercebiotech.com

Rezolute\'s stock plunges 87% after hypoglycemia drug flunks pivotal phase 3 test

Rezolute\'s trial missed its primary endpoint of a change in average weekly hypoglycemia events.\n Rezolute’s stock has plunged 87% after the company’s rare disease drug flunked the final clinical test ahead of a planned approval application.The company had been evaluating ersodetug as a treatment for hypoglycemia in a phase 3 study of 63 patients aged between 3 months and 45 years around the world with congenital hyperinsulinism (HI). The biotech was confident enough in the study’s prospects that it recruited a chief commercial officer back in August to prepare for the commercialization of ersodetug.But those plans have been thrown into doubt this morning as Rezolute revealed the trial missed its primary endpoint of a change in average weekly hypoglycemia events. The 45% reduction in self-monitored events among the highest, 10-mg/kg, ersodetug dose cohort was not statistically significant when compared to the 40% improvement seen in the placebo group, Rezolute explained in a Dec. 11 release.There wasn’t a silver lining to be found in the study’s secondary endpoint, either, with the 25% reduction in time patients experienced hypoglycemia over six months among the 10-mg/kg ersodetug group not being deemed statistically significant when compared to a 5% increase in time across the placebo cohort.Two patients experienced serious hypersensitivity reactions that led to early discontinuation of study drug, although the company claimed “incidence of serious allergic reactions across the program is relatively low compared to biologic or monoclonal antibody treatments.”Investors took fright at the trial results, driving the company’s stock down 87% to $1.40 in early morning trading Thursday, falling from a Wednesday closing price of $10.94.With a phase 3 study of ersodetug in tumor HI ongoing, Rezolute isn’t ready to write off the drug quite yet. The company’s chief medical officer Brian Roberts, M.D., said the biotech plans to meet with the FDA “to consider next steps for the program.”“We are disappointed that the study did not demonstrate significant improvements in glucose-related endpoints relative to placebo as well as for the patients and families living with congenital HI who urgently need new treatment options,” Roberts said in this morning’s release.“At the same time, there are aspects of the results that merit additional investigation, and we are conducting a thorough evaluation to gain a better understanding of the study outcomes, which will inform our path forward,” he added. Patients with hypoglycemia caused by HI currently have limited options. Diazoxide is approved in the indication, but, with response rates ranging from 40% to 74%, there is room to improve on the treatment. Zealand Pharma has been preparing to refile for approval of dasiglucagon, a glucagon analog that it already sells as Zegalogue in other settings, in congenital HI after suffering two rejections in recent years.Rezolute sees barriers to the use of dasiglucagon in congenital HI, though, telling (PDF) investors back in May that the utility in chronic use is unproven and predicting Zealand is likely to need to combine the drug with other therapies.Rezolute’s ersodetug is a monoclonal antibody that binds to the insulin receptor to decrease over-activation by insulin and related substances. Because ersodetug acts downstream from the pancreas, Rezolute had been hoping the drug could be “universally effective at treating hypoglycemia due to any congenital or acquired form of hyperinsulinism.”Hopes for the drug were raised back in 2022 when a phase 2 trial tied ersodetug to a 75% reduction in severe low blood sugar events in children, leading the company to raise $130 million to support a push into phase 3.Only last month, Rezolute was explaining to investors that the company had secured alignment with the FDA on the registrational requirements for submitting an approval application for the therapy.

$Rezolute\'s stock plunges 87% after hypoglycemia drug flunks pivotal phase 3 test$

Phase 3Phase 2Drug ApprovalClinical Result

100 Deals associated with Ersodetug

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperinsulinism	Phase 3	Netherlands	Rezolute, Inc.	16 Apr 2025
Hyperinsulinism	Phase 3	Switzerland	Rezolute, Inc.	16 Apr 2025
Hypoglycemia	Phase 3	Netherlands	Rezolute, Inc.	16 Apr 2025
Hypoglycemia	Phase 3	Switzerland	Rezolute, Inc.	16 Apr 2025
Ichthyosis, Lamellar	Phase 3	United States	Rezolute, Inc.	16 Apr 2025
Ichthyosis, Lamellar	Phase 3	France	Rezolute, Inc.	16 Apr 2025
Ichthyosis, Lamellar	Phase 3	Netherlands	Rezolute, Inc.	16 Apr 2025
Ichthyosis, Lamellar	Phase 3	Switzerland	Rezolute, Inc.	16 Apr 2025
Ichthyosis, Lamellar	Phase 3	United Kingdom	Rezolute, Inc.	16 Apr 2025
Congenital Hyperinsulinism	Phase 3	-	Rezolute, Inc.	14 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06208215 (sunRIZE, GlobeNewswire) Manual	Phase 3	Congenital Hyperinsulinism	-	Ersodetug 5 mg/kg	tlbnpzcmmf(ncsisfmzqp) = aawkdcjgpb fdiifyxsbl (kftrtnggtn ) Not Met	Negative	11 Dec 2025
				Ersodetug 10 mg/kg	tlbnpzcmmf(ncsisfmzqp) = mfspwhtvjb fdiifyxsbl (kftrtnggtn ) Not Met View more
NCT04538989 (Global, multi-center, repeat-dose, phase 2 study of RZ358, Pubmed \| Med)	Phase 2	Congenital Hyperinsulinism Add-on	23	Ersodetug 3 mg/kg	imoxqxaxve(yoyjjxtfxw) = oszowmtfos rofvvkaibs (mqsnczzlmc ) View more	Positive	01 Jun 2025
				Ersodetug 6 mg/kg	imoxqxaxve(yoyjjxtfxw) = ucdddgbeok rofvvkaibs (mqsnczzlmc ) View more
NCT04538989 (Global, multi-center, repeat-dose, phase 2 study of RZ358 \| RIZE, CTgov)	Phase 2	Congenital Hyperinsulinism	23	RZ358 Sequential Group Cohort 1 (RZ358 Cohort 1)	xxouutzqod(qxzgnzrfey) = lueghhycot mwfwduchsd (mkdfvtcret, wuitaxicpt - wxzhqfywiw) View more	-	28 May 2025
				RZ358 Sequential Group Cohort 2 (RZ358 Cohort 2)	xxouutzqod(qxzgnzrfey) = kwfajhkbua mwfwduchsd (mkdfvtcret, cwxrkjtihy - debtjoimfv) View more
NCT04538989 (RIZE, ESPE2022)	Phase 2	Congenital Hyperinsulinism	23	RZ358 3mg/kg	idznnfdttd(pjbsqjzwli) = bzuboklmjs jvduifwagf (ubhzyhtqcp )	Positive	15 Sep 2022
				RZ358 6mg/kg	idznnfdttd(pjbsqjzwli) = hbdyipvshy jvduifwagf (ubhzyhtqcp )
NCT04538989 (RIZE, Corporate Publications) Manual	Phase 2	Congenital Hyperinsulinism	22	RZ358	hmrxmzpana(cccosgajmu) = eutnpmrkfz uebvxaukqk (tyvujlzjsp ) View more	Positive	01 May 2022
ENDO2021	Phase 2	Hypoglycemia insulin \| c-peptide \| ketones ... View more	16	RZ358 3 mg/kg	dpqynwdrwv(bkbyrddyof) = concentration-dependent increases gddcgeyceh (cmqjoipswk ) View more	Positive	03 May 2021
				RZ358 6 mg/kg

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