A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria

NCT03217591 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2022-09-15

Study results available
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Summary

To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.

Conditions

  • Type 2 Diabetes Mellitus With Diabetic Nephropathy

Interventions

DRUG

IW-1973

Oral Tablet

DRUG

IW-1973

Oral Tablet

DRUG

Placebo

Oral Tablet

Sponsors & Collaborators

  • Cyclerion Therapeutics

    collaborator INDUSTRY
  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

  • John Hanrahan, MD MPH · Cyclerion Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-08-20
Completion
2019-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03217591 on ClinicalTrials.gov