A Phase 2 Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Stable Type 2 Diabetes and Hypertension

Inclusion Criteria:

- Patient is ambulatory male or female

- Patient's body mass index score is >20 and <40 kg/m2 at the Screening Visit

- Women of childbearing potential must have a negative pregnancy test at the time of
check-in and must agree to use double-barrier contraception throughout the duration of
the study

- Patient's health is stable with no clinically significant findings on a physical
examination

- Patient has type 2 (ie adult onset) diabetes mellitus diagnosed by a physician or
nurse practitioner > 6 months before the Screening Visit, and an entry HbA1c that does
not mandate prompt intervention for improved control

- Patient has hypertension diagnosed by a physician or nurse pratictioner > 6 months
before the Screening Visit and BP within the protocol's acceptable range

- Patients must be on a stable regimen for glycemic control, and a stable regimen for
hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi)
or angiotensin receptor blocker (ARB)

- Patient has abnormal endothelial function measured by the EndoPAT

- Other inclusion criteria per protocol

Exclusion Criteria:

- Patient has a clinically significant active or unstable medical condition that, in the
opinion of the Investigator, would preclude trial participation

- Patient is on medication(s) that when co-administered with a soluble guanylate cyclase
(sGC) stimulator, could increase the risk of hypotension

- Patient has evidence of severe or active end-organ damage attributable to diabetes

- Patient has severe renal insufficiency, has undergone renal transplantation, or has
planned renal transplantation

- Other exclusion criteria per protocol