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OPK-88003 · 1 trial · 1 indication
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...
OPK-88003 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is a metabolic candidate from Opko Health Inc. and has been studied in a Phase 2 clinical trial in adults with Type 2 Diabetes Mellitus in the United States.
OPK-88003 targets GLP-1 and glucagon, two hormone pathways involved in glucose regulation. By acting on both receptors, the small molecule is designed to engage GLP-1 and glucagon signaling in Type 2 Diabetes Mellitus. It belongs to the hormones target class.
OPK-88003 is being developed by Opko Health Inc., which trades under the ticker OPK. The company is the sponsor of the clinical program evaluating the small molecule in Type 2 Diabetes Mellitus.
OPK-88003 is in Phase 2 development for Type 2 Diabetes Mellitus. It is an investigational drug and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed for this asset.
OPK-88003 has been evaluated in one Phase 2 clinical trial, NCT03406377, titled Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects. The trial was completed, enrolled 113 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.