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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 currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied for its effects on blood sugar control in patients with this condition.
OPK-88003 is being developed by Opko Health Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OPK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Type 2 Diabetes Mellitus.
OPK-88003 is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. A Phase 2 clinical trial has been completed to evaluate the drug's effects and safety in subjects with Type 2 Diabetes Mellitus.
OPK-88003 has one completed Phase 2 clinical trial registered as NCT03406377, titled "Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects." This randomized, double-blind, placebo-controlled trial enrolled 113 participants in the United States and has been completed.
No, OPK-88003 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The drug has completed a Phase 2 clinical trial, but it remains under investigation and has not been authorized for commercial use.