Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03406377 | Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects | PHASE2 | COMPLETED | 113 | — | — | Apr 2, 2018 | Jun 27, 2019 | Jun 15, 2021 | 3 | United States |
To evaluate the effect of dose escalation of QW SC OPK-88003 vs placebo injections on HbA1c absolute change from baseline to after 30 weeks treatment in subjects with T2DM inadequately controlled with diet and exercise alone, or treated with a stable dose of metformin.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Water for injection, Sorbitol, L-Methionine, Sodium Acetate Trihydrate |
| OPK-88003 | EXPERIMENTAL | 70 mg/vial (extractable volume 1 mL) (20mg for 4 weeks, 40 mg for 4 weeks and 70 mg for 22 weeks) |
| Name | Type | Description |
|---|---|---|
| OPK-88003 | DRUG | OPK-88003 subcutaneous injection |
| Placebo | DRUG | Placebo subcutaneous injection |
Inclusion Criteria: * Men or women aged 18 to 80 years with T2DM treated with diet and exercise alone or on a stable dose of metformin (≥ 1000 mg/day), * BMI ≥27 and ≤45 kg/m2 * HbA1c ≥7.0% and ≤10.5% at screening Exclusion Criteria: * Type 1 diabetes mellitus * Previous treatment with incretin m...