Outcome of the Phase IIa Study
Cortendo Invest AB has carried out a double blind placebo controlled, FDA approved phase
IIa study with CORT001 in 72 patients in three centres, two in US (San Diego
and Los Angeles) and one in Norway, Tromsö.
A summary of main outcome parameters are presented in the table below:
| |
CORT001 |
| HbA1c
|
Improved
vs baseline |
| Total
cholesterol |
Improved
vs placebo |
| LDL
cholesterol |
Improved
vs baseline |
| Systolic
blood pressure |
Improved
vs placebo |
| Diastolic
blood pressure |
Improved
vs baseline |
| Microalbuminuria |
Improved
vs placebo |
| Hepatic
steatosis |
Improved
vs baseline |
| Body
Weight* |
Improved
vs baseline |
| Peripheral
insulin resistance |
No
significant change |
| Safety
and tolerability |
Two
patients withdrawn |
| |
No
unexpected safety issues. |
| |
|
| *A change in body weight, although less, was also observed
in the placebo group. |
| |
| |
| The
most important outcome parameters are shown graphically below: |
| |
 |
| |
| CORT001,
Phase IIa study 400 mg dose (a) Improves HbA1c, a marker for glucose control
in diabetes; (b) reduces cholesterol levels; (c) lowers blood pressure. |
| |
| Short-term treatment with an inhibitor of the stress hormone
cortisol produced clinically important reductions in HbA1c, total and
LDL cholesterol, systolic and diastolic blood pressure and hepatic steatosis
(fatty liver). Furthermore, there were important positive findings regarding
microalbuminuria and body weight. Most of the results were consistent
with previous results obtained by Cortendo Invest AB and the treatment was well
tolerated. The study outcomes give strong support for the Cortendo
Invest AB hypothesis
of cortisol hyper-secretion as major cause for the symptoms associated
with Metabolic Syndrome/ Type 2 Diabetes. |
