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Also known as ABT-335
ABT-335 and rosuvastatin · 3 trials · 4 indications
Triglycerides were measured in milligrams/deciliter.
The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
| Arm | Type | Description |
|---|---|---|
| ABT-335 plus rosuvastatin | EXPERIMENTAL | ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks |
| Rosuvastatin | ACTIVE_COMPARATOR | Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks |
| ABT-335 and Rosuvastatin Calcium | EXPERIMENTAL | ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks |
| ABT-335 | ACTIVE_COMPARATOR | ABT-335 135mg monotherapy administered orally, once daily for 12 weeks |
| Rosuvastatin Calcium | ACTIVE_COMPARATOR | Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ABT-335 plus rosuvastatin | DRUG | ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks |
| Rosuvastatin | DRUG | Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks |
| ABT-335 and rosuvastatin calcium | DRUG | ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks |
| ABT-335 | DRUG | ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks |
| rosuvastatin calcium | DRUG | Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks |
Inclusion Criteria * Dyslipidemic participants with Chronic Kidney Disease Stage 3 * For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit\[s\]): * Estimated glomerular filtration rate between 30 and 59 mL/min/1...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran, Muvalaplin |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Enlicitide |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | Obicetrapib |
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0780, Rosuvastatin, AZD4954 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
ABT-335 and rosuvastatin is an investigational small molecule combination therapy being developed by AstraZeneca PLC for dyslipidemia, hypercholesterolemia, and renal insufficiency. It pairs ABT-335 with rosuvastatin calcium and has been studied in Phase 3 clinical trials. It is not described as approved and remains in clinical development.
ABT-335 and rosuvastatin has been studied for dyslipidemia, hypercholesterolemia, and renal insufficiency, including dyslipidemia in patients with stage 3 chronic kidney disease. The Phase 3 program evaluated the combination in adults with these lipid and kidney-related conditions. It is investigational and not described as approved for any indication.
AstraZeneca PLC develops ABT-335 and rosuvastatin. The company trades under the ticker AZN. AstraZeneca sponsored the clinical trials evaluating the combination, including the Phase 3 study comparing it with rosuvastatin monotherapy in patients with dyslipidemia and stage 3 chronic kidney disease.
ABT-335 and rosuvastatin is in Phase 3 development. The program includes completed Phase 3 and Phase 1 trials, and no active trials are currently listed. Because the available information does not describe it as approved, it should be considered investigational and still in clinical development.
ABT-335 and rosuvastatin has been evaluated in completed trials including NCT00463606, a Phase 3 study of 760 subjects with dyslipidemia and hypercholesterolemia; NCT00680017, a 30 week Phase 3 study of 280 subjects with dyslipidemia and stage 3 chronic kidney disease; and NCT00585143, a Phase 1 pharmacokinetic study of 37 subjects with renal impairment.