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

Cyclerion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypertension; Diabetes Mellitus, Type 2

Treatments: Drug: IW-1973; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02906579

C1973-201

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

IW-1973

Experimental group

Description:

Placebo taken once daily Day 1-Day 3; 10 mg IW-1973 take once daily Day 4-Day 6; 20 mg IW-1973 taken once daily Day 7-Day 9; 30 mg IW-1973 taken once daily Day 10-Day 12; 40 mg IW-1973 taken once daily Day 13-Day 15; 50 mg IW-1973 taken once daily Day 16-Day 18

Treatment:

Drug: Matching Placebo

Drug: IW-1973