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

NCT ID: NCT02906579

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-03-17

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IW-1973

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

Group Type: EXPERIMENTAL

Matching Placebo

Intervention Type: DRUG

IW-1973

Intervention Type: DRUG

Interventions

Matching Placebo

Intervention Type: DRUG

IW-1973

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cyclerion Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON Early Phase Unit

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C1973-201

Identifier Type: -

Identifier Source: org_study_id