Memorandum
- The table below includes an overview of ongoing cardiovascular outcomes trials (CVOTs). It includes all of the ongoing CVOTs related to diabetes drugs or PCSK9 inhibitors that we are aware of, though we acknowledge that it may be incomplete. We will continuously update the table as timelines change.
|
Molecule |
Name of Clinical Trial |
Class of Drug |
Study Enrollment |
Primary Outcome Measures |
Expected Completion Date |
|
Tradjenta/Trajenta (linagliptin) vs. glimepiride |
CAROLINA |
DPP-4 inhibitor vs. sulfonylurea |
6,115 |
4-point MACE composite endpoint (CV death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina) |
|
|
Steglatro (ertugliflozin) |
VERTIS CV |
SGLT-2 inhibitor |
8,000 |
3-point MACE composite endpoint (CV death, non-fatal MI, non-fatal stroke) |
|
| Farxiga (dapagliflozin) in HFrEF | Dapa-HF | SGLT-2 inhibitor | 4,744 | composite of CV death, hospitalization for heart failure, or urgent HF visit | December 2019 |
| Jardiance (empagliflozin) in HFpEF | EMPEROR-Preserved | SGLT-2 inhibitor | 4,126 | composite of CV death or hospitalization for heart failure | June 2020 |
| Jardiance (empagliflozin) in HFrEF | EMPEROR-Reduced | SGLT-2 inhibitor | 2,850 | composite of CV death or hospitalization for heart failure | June 2020 |
| Farxiga (dapagliflozin) in CKD | Dapa-CKD | SGLT-2 inhibitor | 4,000 |
Composite of (i) ≥50% sustained decline in eGFR, (ii) reaching ESRD, and (iii) CV or renal death |
November 2020 |
| sotagliflozin | SOLOIST-WHF | SGLT-1/2 dual inhibitor | 4,000 | composite of CV death or hospitalization for heart failure | January 2021 |
| Farxiga (dapagliflozin) in HFpEF | DELIVER | SGLT-2 inhibitor | 4,700 | composite of CV death, hospitalization for heart failure, or urgent HF visit | June 2021 |
| sotagliflozin | SCORED | SGLT-1/2 dual inhibitor | 10,500 | 3-point MACE composite (CV death, non-fatal MI, non-fatal stroke); CV death/hospitalization for heart failure composite | March 2022 |
| Jardiance (empagliflozin) in CKD | EMPA-KIDNEY | SGLT-2 inhibitor | 5,000 | Composite of (i) CKD progression – ESKD, decline in eGFR to <10 mL/min/1.73m², renal death, or a sustained decline of ≥40% in eGFR from randomization, and (ii) CV death | June 2022 |
| semaglutide for obesity | SELECT | GLP-1 agonist | 17,500 | 3-point MACE composite (CV death, non-fatal MI, non-fatal stroke) | September 2023 |
| oral semaglutide | "SOUL 2" | oral GLP-1 agonist | unknown | unknown | unknown |