A Phase 2 interventional study of RZ358 Sequential Group Cohort 1 and RZ358 Sequential Group Cohort 2 in Congenital Hyperinsulinism, sponsored by Rezolute. Completed at 17 sites in 11 countries. Open to participants aged 2 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Rezolute · Phase 2, Interventional, and Treatment
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
There is a significant unmet medical need to develop new therapies aimed at preventing chronic recurrent hypoglycemia in congenital HI, the most common cause of persistent hypoglycemia in children. RZ358 is a human mAb that allosterically attenuates excessive insulin action on target cells. Therefore, RZ358 is ideally suited as a potential therapy for hyperinsulinism, and it is being developed to treat the hypoglycemia associated with diseases such as congenital HI. This is a Phase 2, multicenter, open label clinical study designed to assess the safety and efficacy of four progressively higher doses of RZ358 in separate groups of patients with hyperinsulinemic hypoglycemia due to Congenital HI, not adequately controlled with or without current standard of care. A screening period of up to 5 weeks will evaluate eligibility. Once enrolled, RZ358 will be administered bi-weekly over 8 weeks, and then patients will complete a post-treatment follow-up period of 13 weeks.
38 studies on the registry are indexed under Congenital Hyperinsulinism; 6 are open to participants now.
This study's enrollment of 23 is above the median of 17 across 30 interventional studies indexed under Congenital Hyperinsulinism.
Browse Congenital Hyperinsulinism studies →Rezolute is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: RZ358 Sequential Group Cohort 1
Drug: RZ358 Sequential Group Cohort 2
Drug: RZ358 Sequential Group Cohort 3
Drug: RZ358 Sequential Group Cohort 4
IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks)
IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks)
IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks)
IV infusion for 8 weeks (bi-weekly fixed dose-titration from 3 to 9 mg/kg for the first 4 weeks, followed by a fixed 9 mg/kg dose amount thereafter for the remaining 4 weeks)
Median of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average daily percent time within the glucose target range 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline and End of Treatment (EOT) is reported.
Time frame: 8 weeks
Median Percent Change of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM From Baseline (BL)
The average daily percent time within the glucose target range (70-180 mg/dL) is compared from baseline to end of treatment (EOT) and the median percent change of that difference is reported.
Time frame: 8 weeks
Repeat Dose Pharmacokinetics of RZ358
All patients who received RZ358 and for whom the primary PK data was considered to be sufficient and interpretable were to be included in the PK analyses. Individual and mean plasma concentration data is summarized descriptively at the specified timepoints. The results of this study may be combined with those of other studies for analysis and modeling (e.g., population PK and PK-PD), and therefore the PK parameters are reported separately, as part of an iterative population PK approach.
Time frame: Pre dose Weeks 1,3,5,7, 1-hr post dose Week 1 and Week 7, and Follow up on Days 14, Day 28, Day 42, and Day 105
Median of Average Weekly Overall, Moderate, and Severe Hypoglycemia Events by SMBG at Baseline (BL) and End of Treatment (EOT)
The median of average weekly number of overall hypoglycemia events (\<70 mg/dL \[3.9mmol/L\], moderate hypoglycemia events (\<60 mg/dL \[3.3 mmol/L\] and severe hypoglycemia events (\<50 mg/dL \[2.8mmol/L\]) by SMBG at baseline (BL) and end of treatment (EOT) is reported.
Time frame: 8 weeks
Median Percent Change of Average Weekly Overall, Moderate, and Severe Hypoglycemia Events by SMBG From Baseline (BL)
The average weekly number overall hypoglycemia events (\<70 mg/dL \[3.9mmol/L\], moderate hypoglycemia events (\<60 mg/dL \[3.3 mmol/L\] and severe hypoglycemia events (\<50 mg/dL \[2.8mmol/L\]) by SMBG is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
Time frame: 8 weeks
Median of Average Daily Percent Time With Overall, Moderate, and Severe Hypoglycemia by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average daily percent time in overall (\<70 mg/dL \[\<3.9 mmol/L\]), moderate (\<60 mg/dL \[3.3 mmol/L\]), and severe (\<50 mg/dL \[2.8 mmol/L\]) hypoglycemia at baseline (BL) and end of treatment (EOT) is reported.
Time frame: 8 weeks
Median Percent Change of Average Daily Percent Time With Overall, Moderate, and Severe Hypoglycemia by CGM From Baseline (BL)
The average daily percent time in overall (\<70 mg/dL \[\<3.9 mmol/L\]), moderate (\<60 mg/dL \[3.3 mmol/L\]), and severe (\<50 mg/dL \[2.8 mmol/L\]) hypoglycemia is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
Time frame: 8 weeks
Median of Average Daily Duration (Minutes) With Overall, Moderate, and Severe Hypoglycemia by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average duration (minutes) in overall (\<70 mg/dL \[\<3.9 mmol/L\]), moderate (\<60 mg/dL \[3.3 mmol/L\] ), and severe (\<50 mg/dL \[2.8 mmol/L\]) hypoglycemia by CGM at baseline (BL) and end of treatment (EOT) is reported.
Time frame: 8 weeks
Median Percent Change of Average Daily Duration (Minutes) With Overall, Moderate, and Severe Hypoglycemia by CGM From Baseline (BL)
The average duration (minutes) in overall (\<70 mg/dL \[\<3.9 mmol/L\]), moderate (\<60 mg/dL \[3.3 mmol/L\] ), and severe (\<50 mg/dL \[2.8 mmol/L\]) hypoglycemia by CGM is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
Time frame: 8 weeks
Occurrence of Hypoglycemia During Fasting Challenge
The occurrence of hypoglycemia during a 12 Hour fasting challenge.
Time frame: 8 Weeks
Median of Average Hypoglycemia Events Per Day at Each of the Specified Glucose Thresholds by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average hypoglycemia events per day at each of the specified glucose thresholds \[\<70, \<60, and \<50 mg/dL (3.9, 3.3, and 2.8 mmol/L)\], by CGM at baseline (BL) and end of treatment (EOT) is reported.
Time frame: 8 weeks
Median Net Change of Average Hypoglycemia Events Per Day at Each of the Specified Glucose Thresholds by CGM From Baseline (BL)
The average hypoglycemia events per day at each of the specified glucose thresholds \[\<70, \<60, and \<50 mg/dL (3.9, 3.3, and 2.8 mmol/L)\], by CGM is compared from baseline (BL) to end of treatment (EOT) and the median net changes of those differences are reported.
Time frame: 8 weeks
Median of Average 8-hour Overnight Percent Time in Glucose Target Range of 70-180mg/dL by CGM at Baseline (BL) and End of Treatment (EOT)
The median of average 8-hour overnight (12am-8am) percent time within the glucose target range (70-180 mg/dL) at baseline (BL) and end of treatment (EOT) is reported.
Time frame: 8 weeks
Median Percent Change of Average 8-hour Overnight Percent Time in Glucose Target Range of 70-180mg/dL by CGM From Baseline (BL)
The average 8-hour overnight (12am-8am) percent time within the glucose target range (70-180 mg/dL) is compared from baseline (BL) to end of treeatment (EOT) and the median percent change of that difference is reported.
Time frame: 8 weeks
Sites were recruited based on cHI professional expertise and sufficient patient panels and advocacy referrals.
| Milestone | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 |
|---|---|---|---|---|
| Started | 4 | 8 | 8 | 3 |
| Completed | 4 | 8 | 8 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
The median of average daily percent time within the glucose target range 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline and End of Treatment (EOT) is reported.
| Daily Percent Time | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median of Average Daily Percent Time in 70-180 mg/dL at BL | 81.7 (70.5 to 92.5) | 72.9 (67.5 to 80.9) | 83.4 (43.2 to 94.8) | 59.3 (25.7 to 110) | 76.9 (65.3 to 80.7) |
| Median of Average Daily Percent Time in 70-180 mg/dL at 8 weeks (EOT) | 84.8 (71.6 to 100.3) | 78.5 (61.1 to 88.6) | 82.9 (67.1 to 91.6) | 70.8 (50.9 to 93.9) | 79.1 (72.0 to 83.9) |
The average daily percent time within the glucose target range (70-180 mg/dL) is compared from baseline to end of treatment (EOT) and the median percent change of that difference is reported.
| Percent Change | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Percent Change of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM From Baseline (BL) | 6.19 (-2.80 to 13.6) | 0.31 (-19.7 to 24.2) | 5.52 (-82.3 to 215.2) | 9.07 (-29.6 to 48.4) | 4.59 (-16.7 to 65.1) |
All patients who received RZ358 and for whom the primary PK data was considered to be sufficient and interpretable were to be included in the PK analyses. Individual and mean plasma concentration data is summarized descriptively at the specified timepoints. The results of this study may be combined with those of other studies for analysis and modeling (e.g., population PK and PK-PD), and therefore the PK parameters are reported separately, as part of an iterative population PK approach.
| ng/mL | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Pre dose Week 1 | — | — | 55648 (55648 to 55648) | — | 55648 (55648 to 55648) |
| Post dose (1hr) Wk1/D1 | 29093 (1308 to 96685) | 120368 (74257 to 190700) | 164047 (73398 to 250230) | 43593 (36330 to 53742) | 89333 (1308 to 250230) |
| Pre dose Week 3 | 38951 (15363 to 83824) | 28397 (21187 to 35857) | 41512 (19816 to 60351) | 8961 (7244 to 10613) | 28999 (7244 to 83824) |
| Pre dose Week 5 | 20692 (20692 to 20692) | 82646 (36116 to 376850) | 74457 (51606 to 99696) | 34243 (26150 to 42212) | 64808 (20692 to 376850) |
| Pre dose Week 7 | 31902 (31902 to 31902) | 56919 (29669 to 82349) | 95721 (55202 to 123120) | 55532 (48740 to 68459) | 67823 (29669 to 123120) |
| Post dose (1hr) Week 7 | 94593 (94593 to 94593) | 178090 (123230 to 245640) | 280843 (141480 to 527410) | 245905 (181540 to 434760) | 217295 (94593 to 527410) |
| Follow-Up Day 14/EOT | 59542 (42139 to 76282) | 70990 (48766 to 99871) | 105005 (78798 to 129580) | 110134 (93403 to 127370) | 82683 (42139 to 129580) |
| Follow-up Day 28 | 46751 (27504 to 125040) | 39385 (26997 to 59121) | 63201 (45579 to 108180) | 52039 (48235 to 57834) | 50125 (26997 to 125040) |
| Follow-up Day 42 | 23166 (14390 to 29879) | 24226 (13552 to 37256) | 43034 (26741 to 60868) | 37394 (30944 to 50353) | 31066 (13552 to 60868) |
| Follow-up Day 105 | 2307 (1201 to 3412) | 4231 (1105 to 15651) | 9269 (3743 to 14616) | 4194 (3297 to 6469) | 4857 (1105 to 15651) |
The median of average weekly number of overall hypoglycemia events (\<70 mg/dL \[3.9mmol/L\], moderate hypoglycemia events (\<60 mg/dL \[3.3 mmol/L\] and severe hypoglycemia events (\<50 mg/dL \[2.8mmol/L\]) by SMBG at baseline (BL) and end of treatment (EOT) is reported.
| Hypoglycemia Events | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Overall Hypoglycemia Events (<70 mg/dL; <3.9 mmol/L) at BL | 10.1 (2.46 to 17.7) | 12.5 (2.94 to 28.9) | 13.0 (9.15 to 23.2) | 9.30 (-6.02 to 24.6) | 11.5 (9.43 to 19.5) |
| Median Overall Hypoglycemia Events (<70 mg/dL; <3.9 mmol/L) at 8 Weeks (EOT) | 9.92 (1.85 to 15.4) | 6.60 (2.40 to 15.6) | 1.87 (-2.70 to 12.8) | 7.60 (-19.0 to 34.2) | 5.00 (4.12 to 10.7) |
| Median Moderate Hypoglycemia Events (<60 mg/dL; <3.3 mmol/L) at BL | 3.06 (-0.84 to 8.05) | 6.69 (0.158 to 21.2) | 9.00 (4.18 to 19.0) | 3.69 (-5.08 to 12.5) | 5.99 (4.80 to 13.7) |
| Median Moderate Hypoglycemia Events (<60 mg/dL; <3.3 mmol/L) at 8 Weeks (EOT) | 6.42 (-1.52 to 12.9) | 3.17 (0.945 to 9.00) | 0.47 (-3.13 to 10.1) | 4.18 (-4.40 to 12.8) | 2.75 (2.08 to 6.89) |
| Median Severe Hypoglycemia Events (<50 mg/dL; <2.8 mmol/L) at BL | 1.31 (0.32 to 2.58) | 2.59 (-0.71 to 10.4) | 3.50 (-0.20 to 8.66) | 0.91 (-4.24 to 6.05) | 1.90 (1.35 to 6.10) |
| Median Severe Hypoglycemia Events (<50 mg/dL; <2.8 mmol/L) at 8 Weeks (EOT) | 1.17 (-3.47 to 6.97) | 0.94 (0.15 to 2.34) | 0.00 (-0.74 to 2.77) | 0.52 (0.27 to 0.77) | 0.49 (0.45 to 1.88) |
The average weekly number overall hypoglycemia events (\<70 mg/dL \[3.9mmol/L\], moderate hypoglycemia events (\<60 mg/dL \[3.3 mmol/L\] and severe hypoglycemia events (\<50 mg/dL \[2.8mmol/L\]) by SMBG is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
| Percent Change | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Percent Change of Overall Hypoglycemia Events (<70 mg/dL; <3.9 mmol/L) from BL | -1.6 (-138 to 131) | -47.7 (-71.9 to -17.6) | -84.4 (-101 to -50.3) | -19.9 (-174 to 135) | -58.9 (-65.9 to -27.9) |
| Median Percent Change of Moderate Hypoglycemia Events (<60 mg/dL; <3.3 mmol/L) from BL | 14.6 (-314 to 498) | -65.3 (-84.5 to -18.8) | -94.8 (-106 to -58.0) | 20.8 (-499 to 540) | -64.4 (-74.1 to 7.30) |
| Median Percent Change of Severe Hypoglycemia Events (<50 mg/dL; <2.8 mmol/L) from BL | -40.3 (-459 to 550) | -78.2 (-107 to 4.93) | -100 (-105 to -70.2) | -26.9 (-471 to 417) | -78.2 (-89.3 to -4.32) |
The median of average daily percent time in overall (\<70 mg/dL \[\<3.9 mmol/L\]), moderate (\<60 mg/dL \[3.3 mmol/L\]), and severe (\<50 mg/dL \[2.8 mmol/L\]) hypoglycemia at baseline (BL) and end of treatment (EOT) is reported.
| Daily Percent Time | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Daily Percent Time in Overall Hypoglycemia (<70mg/dL; <3.9 mmol/L) at BL | 16.3 (7.83 to 24.8) | 20.3 (14.3 to 29.1) | 13.7 (-1.17 to 53.7) | 34.4 (-11.4 to 69.8) | 16.2 (15.2 to 31.2) |
| Median Daily Percent Time in Overall Hypoglycemia (<70mg/dL; <3.9 mmol/L) at 8 Weeks (EOT) | 12.3 (1.28 to 19.6) | 6.68 (3.05 to 16.0) | 5.42 (-1.30 to 20.6) | 20.4 (-6.40 to 38.9) | 8.54 (6.73 to 14.6) |
| Median Daily Percent Time in Moderate Hypoglycemia (<60 mg/dL; <3.3 mmol/L) at BL | 6.85 (1.53 to 11.5) | 8.75 (6.38 to 17.3) | 5.22 (-6.30 to 36.8) | 19.5 (-9.22 to 37.9) | 7.31 (6.19 to 18.4) |
| Median Daily Percent Time in Moderate Hypoglycemia (<60 mg/dL; <3.3 mmol/L) at 8 Weeks (EOT) | 5.13 (0.05 to 9.39) | 3.25 (1.31 to 7.60) | 1.79 (-0.72 to 10.1) | 7.35 (-0.43 to 13.9) | 3.81 (3.06 to 6.73) |
| Median Daily Percent Time in Severe Hypoglycemia (<50 mg/dL; < 2.8 mmol/L) at BL | 1.97 (-0.09 to 3.72) | 3.57 (2.12 to 8.17) | 1.12 (-3.70 to 13.9) | 3.03 (-4.08 to 11.2) | 2.56 (1.76 to 6.84) |
| Median Daily Percent Time in Severe Hypoglycemia (<50 mg/dL; < 2.8 mmol/L) at 8 Weeks (EOT) | 1.27 (-0.216 to 3.04) | 1.05 (0.49 to 3.02) | 0.61 (-0.17 to 3.65) | 1.27 (-0.67 to 3.93) | 1.15 (1.01 to 2.33) |
The average daily percent time in overall (\<70 mg/dL \[\<3.9 mmol/L\]), moderate (\<60 mg/dL \[3.3 mmol/L\]), and severe (\<50 mg/dL \[2.8 mmol/L\]) hypoglycemia is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
| Percent Change | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Percent Change in Daily Percent Time in Overall Hypoglycemia (<70mg/dL; <3.9 mmol/L) from BL | -31.1 (-84.0 to 6.00) | -64.6 (-83.7 to -22.4) | -61.0 (-95.2 to -22.0) | -46.6 (-53.1 to -36.2) | -53.5 (-65.5 to -36.6) |
| Median Percent Change in Daily Percent Time in Moderate Hypoglycemia (<60mg/dL; <3.3 mmol/L) from BL | -19.3 (-103 to 66.5) | -65.9 (-94.9 to -8.67) | -75.9 (-107 to 7.76) | -53.9 (-130 to 56.2) | -60.2 (-65.9 to -19.9) |
| Median Percent Change in Daily Percent Time in Severe Hypoglycemia (<50 mg/dL; < 2.8 mmol/L) from BL | -21.9 (-299 to 447) | -74.4 (-120 to 54.0) | -85.0 (-164 to 178) | -60.7 (-213 to 173) | -64.8 (-66.6 to 68.8) |
The median of average duration (minutes) in overall (\<70 mg/dL \[\<3.9 mmol/L\]), moderate (\<60 mg/dL \[3.3 mmol/L\] ), and severe (\<50 mg/dL \[2.8 mmol/L\]) hypoglycemia by CGM at baseline (BL) and end of treatment (EOT) is reported.
| Daily Minutes in Hypoglycemia | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Daily Duration (min) of Overall Hypoglycemia (<70 mg/dL; 3.9 mmol/L) at BL | 204 (107 to 301) | 266 (185 to 379) | 180 (8.77 to 675) | 472 (-177 to 966) | 214 (202 to 402) |
| Median Daily Duration (min) of Overall Hypoglycemia (<70 mg/dL; 3.9 mmol/L) at 8 Weeks (EOT) | 158 (10.1 to 268) | 84.1 (36.5 to 208) | 76.7 (-19.5 to 293) | 287 (-93.6 to 554) | 99.1 (89.5 to 200) |
| Median Daily Duration (min) of Moderate Hypoglycemia (<60 mg/dL; 3.3 mmol/L) at BL | 90.5 (21.8 to 141) | 113 (80.6 to 226) | 67.9 (-62.9 to 449) | 257 (-134 to 513) | 97.5 (83.7 to 232) |
| Median Daily Duration (min) of Moderate Hypoglycemia (<60 mg/dL; 3.3 mmol/L) at 8 Weeks (EOT) | 65.8 (-4.32 to 130) | 35.7 (13.6 to 93.9) | 25.3 (-10.8 to 144) | 105 (-6.03 to 195) | 46.0 (39.3 to 90.6) |
| Median Daily Duration (min) of Severe Hypoglycemia (<50 mg/dL; 2.8 mmol/L) at BL | 26.1 (-0.28 to 46.7) | 46.3 (26.1 to 105) | 14.3 (-37.5 to 159) | 39.3 (-61.1 to 152) | 32.7 (24.1 to 83.1) |
| Median Daily Duration (min) of Severe Hypoglycemia (<50 mg/dL; 2.8 mmol/L) at 8 Weeks (EOT) | 15.00 (-5.07 to 41.2) | 14.8 (6.14 to 30.1) | 8.67 (-2.36 to 50.9) | 16.7 (-9.13 to 53.6) | 14.8 (12.2 to 29.0) |
The average duration (minutes) in overall (\<70 mg/dL \[\<3.9 mmol/L\]), moderate (\<60 mg/dL \[3.3 mmol/L\] ), and severe (\<50 mg/dL \[2.8 mmol/L\]) hypoglycemia by CGM is compared from baseline (BL) to end of treatment (EOT) and the median percent changes of those differences are reported.
| Percent Change | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Percent Change in Daily Duration (min) of Overall Hypoglycemia (<70mg/dL; 3.9 mmol/L) from BL | -22.2 (-83.4 to 13.0) | -63.7 (-82.0 to -30.1) | -57.5 (-94.3 to -18.2) | -40.2 (-47.5 to -34.8) | -49.1 (-64.4 to -36.1) |
| Median Percent Change in Daily Duration (min) of Moderate Hypoglycemia (<60mg/dL; 3.3mmol/L) from BL | 9.19 (-97.7 to 69.9) | -65.8 (-92.9 to -23.8) | -70.9 (-106 to 9.37) | -52.8 (-147 to 89.9) | -58.1 (-65.5 to -20.5) |
| Median Percent Change in Daily Duration (min) of Severe Hypoglycemia (<50 mg/dL; 2.8 mmol/L) from BL | -18.6 (-272 to 400) | -77.0 (-107 to 7.36) | -81.2 (-160 to 171) | -59.8 (-325 to 357) | -63.0 (-66.2 to 61.3) |
The occurrence of hypoglycemia during a 12 Hour fasting challenge.
| participants | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Number of patients able to complete fast at Baseline (n) | 3 | 2 | 0 | 0 | 5 |
| Number of patients able to complete fast at EOT (n) | 3 | 1 | 2 | 1 | 7 |
The median of average hypoglycemia events per day at each of the specified glucose thresholds \[\<70, \<60, and \<50 mg/dL (3.9, 3.3, and 2.8 mmol/L)\], by CGM at baseline (BL) and end of treatment (EOT) is reported.
| Hypoglycemia Events Per Day | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median of Average Hypoglycemia Events Per Day <70mg/dL (3.9mmol/L) at BL | 3.00 (1.71 to 4.25) | 3.50 (2.40 to 4.30) | 2.46 (1.49 to 4.84) | 4.47 (2.18 to 6.22) | 3.37 (2.77 to 3.91) |
| Median of Average Hypoglycemia Events Per Day <70mg/dL (3.9mmol/L) at 8 Weeks (EOT) | 2.37 (0.78 to 3.88) | 1.70 (0.93 to 3.78) | 2.33 (0.09 to 4.83) | 3.33 (-1.05 to 8.11) | 2.23 (1.72 to 3.37) |
| Median of Average Hypoglycemia Events Per Day <60 mg/dL (3.3mmol/L) at BL | 1.73 (1.11 to 2.62) | 2.22 (1.59 to 3.52) | 1.77 (0.92 to 3.23) | 3.07 (0.30 to 5.53) | 2.00 (1.85 to 2.80) |
| Median of Average Hypoglycemia Events Per Day <60 mg/dL (3.3mmol/L) at 8 Weeks (EOT) | 1.54 (0.60 to 2.53) | 1.06 (0.50 to 2.92) | 1.60 (-0.14 to 3.72) | 2.07 (-0.86 to 5.84) | 1.50 (1.15 to 2.48) |
| Median Average Hypoglycemia Events Per Day <50mg/dL(2.8mmol/L) at BL | 0.91 (0.08 to 1.69) | 1.29 (0.61 to 2.33) | 0.79 (0.30 to 1.25) | 1.67 (-0.62 to 3.27) | 1.13 (0.77 to 1.47) |
| Median Average Hypoglycemia Events Per Day <50mg/dL(2.8mmol/L) at 8 Weeks (EOT) | 0.74 (0.20 to 1.18) | 0.53 (0.23 to 1.40) | 0.60 (0.03 to 1.55) | 1.00 (-0.12 to 2.20) | 0.64 (0.54 to 1.09) |
The average hypoglycemia events per day at each of the specified glucose thresholds \[\<70, \<60, and \<50 mg/dL (3.9, 3.3, and 2.8 mmol/L)\], by CGM is compared from baseline (BL) to end of treatment (EOT) and the median net changes of those differences are reported.
| Events Per Day | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Net Change of Average Hypoglycemia Events Per Day <70 mg/dL (3.9mmol/L) from BL | -0.47 (-1.98 to 0.69) | -1.41 (-2.04 to 0.04) | -1.49 (-3.76 to 2.34) | -1.14 (-3.48 to 2.14) | -1.05 (-1.67 to 0.08) |
| Median Net Change of Average Hypoglycemia Events Per Day <60 mg/dL (3.3mmol/L) from BL | -0.32 (-1.48 to 0.89) | -0.82 (-1.57 to -0.13) | -0.63 (-2.48 to 1.90) | -0.39 (-1.82 to 0.97) | -0.61 (-1.14 to 0.12) |
| Median Net Change of Average Hypoglycemia Events Per Day <50mg/dL(2.8mmol/L) from BL | -0.28 (-0.94 to 0.54) | -0.98 (-1.24 to -0.08) | -0.06 (-0.72 to 0.76) | -0.35 (-2.33 to 1.76) | -0.30 (-0.63 to 0.01) |
The median of average 8-hour overnight (12am-8am) percent time within the glucose target range (70-180 mg/dL) at baseline (BL) and end of treatment (EOT) is reported.
| 8-hour Overnight Percent Time | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median of Average 8h Overnight Percent Time in 70-180 mg/dL at BL | 80.8 (60.2 to 103) | 75.0 (70.1 to 86.6) | 82.1 (36.4 to 99.6) | 48.0 (-1.33 to 121) | 75.0 (63.1 to 83.1) |
| Median of Average 8h Overnight Percent Time in 70-180 mg/dL at 8 Weeks (EOT) | 84.4 (68.2 to 103) | 81.1 (55.7 to 94.1) | 89.2 (62.5 to 96.0) | 73.8 (51.0 to 91.4) | 80.1 (69.9 to 85.6) |
The average 8-hour overnight (12am-8am) percent time within the glucose target range (70-180 mg/dL) is compared from baseline (BL) to end of treeatment (EOT) and the median percent change of that difference is reported.
| Percent Change | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | RZ358 Pooled |
|---|---|---|---|---|---|
| Median Percent Change of Average 8-hour Overnight Percent Time in Glucose Target Range of 70-180mg/dL by CGM From Baseline (BL) | 7.59 (-4.71 to 15.8) | 3.67 (-28.6 to 22.4) | -2.64 (-59.1 to 211) | 44.1 (-58.7 to 116) | 4.22 (-11.1 to 66.9) |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RZ358 Cohort 1 | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| RZ358 Cohort 2 | 0/8 (0%) | 2/8 (25%) | 7/8 (87.5%) |
| RZ358 Cohort 3 | 0/8 (0%) | 1/8 (12.5%) | 5/8 (62.5%) |
| RZ358 Cohort 4 | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 |
|---|---|---|---|---|
| Hypoglycemia with LOCEndocrine disorders | 0/4 | 1/8 | 0/8 | 0/3 |
| Tonic-Clonic SeizureNervous system disorders | 0/4 | 0/8 | 1/8 | 0/3 |
| Eosinophilic LeukocytosisBlood and lymphatic system disorders | 0/4 | 1/8 | 0/8 | 0/3 |
| Event | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 |
|---|---|---|---|---|
| PhlebitisVascular disorders | 0/4 | 1/8 | 0/8 | 1/3 |
| Dermatitis ContactSkin and subcutaneous tissue disorders | 0/4 | 1/8 | 0/8 | 1/3 |
| LeukocyturiaRenal and urinary disorders | 0/4 | 0/8 | 0/8 | 1/3 |
| Covid-19Infections and infestations | 0/4 | 2/8 | 0/8 | 1/3 |
| ChalazionEye disorders | 1/4 | 0/8 | 0/8 | 0/3 |
| Upper Respiratory InfectionInfections and infestations | 1/4 | 0/8 | 0/8 | 0/3 |
| ExtravasationGeneral disorders | 0/4 | 1/8 | 0/8 | 0/3 |
| FatigueGeneral disorders | 0/4 | 1/8 | 0/8 | 0/3 |
| Infusion Site ReactionGeneral disorders | 0/4 | 1/8 | 0/8 | 0/3 |
| Medical Device PainGeneral disorders | 0/4 | 1/8 | 0/8 | 0/3 |
| Age, Categorical(Participants) | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | Total |
|---|---|---|---|---|---|
| <=18 years | 4 | 7 | 8 | 3 | 22 |
| Between 18 and 65 years | 0 | 1 | 0 | 0 | 1 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | Total |
|---|---|---|---|---|---|
| Mean | 5.8 ± 4.35 | 9.3 ± 6.88 | 5.8 ± 5.12 | 4.0 ± 2.00 | 6.7 ± 5.50 |
| Sex: Female, Male(Participants) | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | Total |
|---|---|---|---|---|---|
| Female | 4 | 5 | 3 | 1 | 13 |
| Male | 0 | 3 | 5 | 2 | 10 |
| Ethnicity (NIH/OMB)(Participants) | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 6 | 8 | 3 | 21 |
| Unknown or Not Reported | 0 | 2 | 0 | 0 | 2 |
| Race (NIH/OMB)(Participants) | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 4 | 6 | 7 | 3 | 20 |
| More than one race | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 2 | 0 | 0 | 2 |
| Region of Enrollment(participants) | RZ358 Cohort 1 | RZ358 Cohort 2 | RZ358 Cohort 3 | RZ358 Cohort 4 | Total |
|---|---|---|---|---|---|
| Turkey | 0 | 3 | 4 | 0 | 7 |
| United States | 0 | 1 | 0 | 0 | 1 |
| Denmark | 0 | 1 | 0 | 0 | 1 |
| United Kingdom | 0 | 1 | 1 | 0 | 2 |
| Georgia | 1 | 0 | 0 | 0 | 1 |
| Israel | 0 | 1 | 0 | 0 | 1 |
| Bulgaria | 3 | 0 | 0 | 0 | 3 |
| Germany | 0 | 0 | 1 | 0 | 1 |
| Russia | 0 | 0 | 2 | 3 | 5 |
| Spain | 0 | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2020 to primary completion in Apr 2022, 25 months.
Results were first posted in May 2025, 3 years 1 month after primary completion.
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Studies of the drug tested here: Ersodetug
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