Trial Outcomes & Findings for OPT101 in Type 1 Diabetes Patients (NCT NCT05428943)
NCT ID: NCT05428943
Last Updated: 2026-08-10
Results Overview
Number of treatment-related adverse events as assessed by CTCAE v4.0 over 42 days for all participants.
COMPLETED
PHASE1
24 participants
42 days
2026-08-10
Participant Flow
Able and willing and able to give informed consent for the trial Male or female aged ≥18 years on the day of signing informed consent Diagnosis of T1D within the last 20 years Is medically stable based on physical examination, medical history, laboratory results, and vital signs performed at screening Women of childbearing potential must have a negative highly sensitive serum test (beta- human chorionic gonadotropin) at screening and a negative urine pregnancy test at the Visit 1
Subjects will be randomized to OPT101 or placebo within each dosing group in a 2:1 ratio. Each patient will be assigned a subject ID and will only be identified by this unique ID. If, as an exception, it is necessary for safety or regulatory reasons to identify the subject, all parties will be bound to keep this information confidential. The subject ID will be used for patient identification throughout the study. The numbers will be assigned sequentially. The subject ID should be used on al
Participant milestones
| Measure |
1.1 mg/kg OPT101
8 Subjects received at least one does of 1.1 mg/kg OPT101. 2 Subjects did not complete the study.
|
2.8 mg/kg OPT101
8 Subjects received at least one does of 2.8 mg/kg OPT101. 2 Subjects did not complete the study.
|
Placebo OPT101-PTM
8 Subjects received at least one does Placebo OPT101-PTM. 2 Subjects did not complete the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OPT101 in Type 1 Diabetes Patients
Baseline characteristics by cohort
| Measure |
1.1 mg/kg OPT101
n=6 Participants
Baseline Characteristics
|
2.8 mg/kg OPT101
n=6 Participants
Baseline Characteristics
|
Placebo OPT101-PTM
n=8 Participants
Baseline Characteristics
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Mean Years
|
28.8 Years
STANDARD_DEVIATION 4.3 • n=54 Participants
|
32.3 Years
STANDARD_DEVIATION 10.2 • n=54 Participants
|
32.0 Years
STANDARD_DEVIATION 7.3 • n=27 Participants
|
31.1 Years
STANDARD_DEVIATION 7.4 • n=26 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
5 Participants
n=27 Participants
|
11 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
% White
|
6 Participants
n=54 Participants
|
6 Participants
n=54 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
% Hispanic or Latino
|
2 Participants
n=54 Participants
|
2 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
% Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
% Asian, Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
|
Weight of Subject (kg)
|
74.0 kg
n=54 Participants
|
75.2 kg
n=54 Participants
|
79.3 kg
n=27 Participants
|
76.5 kg
n=26 Participants
|
PRIMARY outcome
Timeframe: 42 daysNumber of treatment-related adverse events as assessed by CTCAE v4.0 over 42 days for all participants.
Outcome measures
| Measure |
1.1 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 1.1 mg/kg OPT101
|
2.8 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 2.8 mg/kg OPT101
|
Placebo OPT101-PTM
n=8 Participants
AUC-t outcome for Placebo OPT101-PTM
|
|---|---|---|---|
|
Number of Treatment-related AE's as Assessed by CTCAE v4.0
|
1 Adverse Events
|
1 Adverse Events
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Subjects dosed with 1.1 or 2.8 mg/kg by eight 30-minute infusion given over 42 days. The subjects with below limit of quantitation (BLQ, 25 pg/mL) were given Placebo.
Blood samples will be collected to determine the serum concentrations of OPT101 (mg/kg)
Outcome measures
| Measure |
1.1 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 1.1 mg/kg OPT101
|
2.8 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 2.8 mg/kg OPT101
|
Placebo OPT101-PTM
n=6 Participants
AUC-t outcome for Placebo OPT101-PTM
|
|---|---|---|---|
|
Serum Samples Collected to Determine AUC0-t
|
2197643 pg/mL*min
Standard Deviation 1436405
|
1839862 pg/mL*min
Standard Deviation 2443513
|
NA pg/mL*min
Standard Deviation NA
Below detectable limit
|
SECONDARY outcome
Timeframe: 42 DaysBlood samples will be collected to determine the serum Cmax levels of OPT101 (pg/mL)
Outcome measures
| Measure |
1.1 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 1.1 mg/kg OPT101
|
2.8 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 2.8 mg/kg OPT101
|
Placebo OPT101-PTM
n=6 Participants
AUC-t outcome for Placebo OPT101-PTM
|
|---|---|---|---|
|
Serum Samples Collected to Determine Cmax
|
71333 pg/mL
Standard Deviation 47759
|
56764 pg/mL
Standard Deviation 77354
|
NA pg/mL
Standard Deviation NA
Below detectable limits
|
SECONDARY outcome
Timeframe: 42 daysBlood samples will be collected to determine the CL/F values of OPT101 (mL/min/kg)
Outcome measures
| Measure |
1.1 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 1.1 mg/kg OPT101
|
2.8 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 2.8 mg/kg OPT101
|
Placebo OPT101-PTM
n=6 Participants
AUC-t outcome for Placebo OPT101-PTM
|
|---|---|---|---|
|
Serum Samples Collected to Determine CL/F
|
0.40 mL/min/kg
Standard Deviation 0.14
|
3.84 mL/min/kg
Standard Deviation 3.15
|
NA mL/min/kg
Standard Deviation NA
Below detectable limits
|
SECONDARY outcome
Timeframe: 42 daysBlood samples will be collected to determine the serum concentrations of OPT101 (mg/kg)
Outcome measures
| Measure |
1.1 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 1.1 mg/kg OPT101
|
2.8 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 2.8 mg/kg OPT101
|
Placebo OPT101-PTM
n=6 Participants
AUC-t outcome for Placebo OPT101-PTM
|
|---|---|---|---|
|
Serum Samples Collected to Determine t1/2
|
2.3 minutes
Standard Deviation 0.9
|
2.0 minutes
Standard Deviation 0.4
|
NA minutes
Standard Deviation NA
Below detectable limits
|
SECONDARY outcome
Timeframe: 56 daysSerum samples collected to determine HbA1C levels from baseline pre mixed meal tolerance to Day 56 pre mixed meal tolerance test of OPT101 (mmol/mole)
Outcome measures
| Measure |
1.1 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 1.1 mg/kg OPT101
|
2.8 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 2.8 mg/kg OPT101
|
Placebo OPT101-PTM
n=6 Participants
AUC-t outcome for Placebo OPT101-PTM
|
|---|---|---|---|
|
Serum Samples Collected to Determine HbA1C From Baseline Pre Mixed Meal Tolerance Test to Day 56 Pre Mixed Meal Tolerance
|
0.53 mmol/mole
Standard Deviation 0.83
|
0.12 mmol/mole
Standard Deviation 0.48
|
0.06 mmol/mole
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 42 daysSerum samples collected to determine C-Peptide values (ng/mL), post mixed-meal tolerance for End of Study (EOS).
Outcome measures
| Measure |
1.1 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 1.1 mg/kg OPT101
|
2.8 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 2.8 mg/kg OPT101
|
Placebo OPT101-PTM
n=6 Participants
AUC-t outcome for Placebo OPT101-PTM
|
|---|---|---|---|
|
Serum Samples Collected to Determine C-peptide Post Mixed Meal Tolerance Test
|
0.03 ng/mL
Standard Deviation 0.07
|
0.07 ng/mL
Standard Deviation 0.26
|
0.16 ng/mL
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: 42 daysSerum samples collected to determine glucose levels (mmol/L) post mixed meal tolerance test at End-of-Study
Outcome measures
| Measure |
1.1 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 1.1 mg/kg OPT101
|
2.8 mg/kg OPT101
n=6 Participants
AUC0-t outcome for 2.8 mg/kg OPT101
|
Placebo OPT101-PTM
n=6 Participants
AUC-t outcome for Placebo OPT101-PTM
|
|---|---|---|---|
|
Serum Samples Collected to Determine Glucose Levels Post Mixed Meal Tolerance Test at End-of-Study
|
0.53 mmol/L
Standard Deviation 0.83
|
0.12 mmol/L
Standard Deviation 0.48
|
0.06 mmol/L
Standard Deviation 0.43
|
Adverse Events
Placebo OPT101-PTM
1.1 mg/kg OPT101
2.8 mg/kg OPT101
Serious adverse events
| Measure |
Placebo OPT101-PTM
n=8 participants at risk
Total Number of Adverse Events
|
1.1 mg/kg OPT101
n=6 participants at risk
Total Number of Adverse Events
|
2.8 mg/kg OPT101
n=6 participants at risk
Total Number of Adverse Events
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Infusion site extravasation
|
0.00%
0/8 • From enrollment until end of study, 42 days
Emergent Adverse Events
|
0.00%
0/6 • From enrollment until end of study, 42 days
Emergent Adverse Events
|
0.00%
0/6 • From enrollment until end of study, 42 days
Emergent Adverse Events
|
Other adverse events
| Measure |
Placebo OPT101-PTM
n=8 participants at risk
Total Number of Adverse Events
|
1.1 mg/kg OPT101
n=6 participants at risk
Total Number of Adverse Events
|
2.8 mg/kg OPT101
n=6 participants at risk
Total Number of Adverse Events
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/8 • From enrollment until end of study, 42 days
Emergent Adverse Events
|
16.7%
1/6 • From enrollment until end of study, 42 days
Emergent Adverse Events
|
16.7%
1/6 • From enrollment until end of study, 42 days
Emergent Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER