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

An Open-label, Phase 2a Trial to Evaluate the Effect of Escalating Doses of IW-1973 on Tolerability, Endothelial Function, and Hemodynamics in Patients With Stable Type 2 Diabetes and Hypertension

To evaluate the impact of escalating doses of IW-1973 on endothelial function [using EndoPAT to measure fingertip small vessel pulse volume], blood pressure (BP), and heart rate.

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 practitioner > 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