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
screening and check-in and must agree to use protocol-specified contraception
throughout the duration of the study

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

- Patient has type 2 (ie, adult onset) diabetes mellitus diagnosed by a physician or
nurse practitioner > 6 months before the Screening Visit, is on a stable glycemic
control medication, and protocol specified HbA1c values at the Screening Visit

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

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

- 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

- Patient is an active smoker or has used any nicotine-containing products (cigarettes,
e-cigarettes, vape pens, cigars, chewing tobacco, gum, patches) during the 6 months
before Check-in. Use of nicotine is excluded during the study until after the End of
Trial Visit.

- Other exclusion criteria per protocol