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: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03091920

C1973-202

Details and patient eligibility

About

To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of 2 treatment regimens of IW-1973 tablet (40 mg per day) administered orally for 2 weeks to patients with stable type 2 diabetes mellitus and hypertension.

Enrollment: 26 patients

Sex: All

Ages: 30 to 75 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/m^2 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 hemoglobin (Hb)A1c values at the Screening Visit
• Patient has hypertension diagnosed by a physician or nurse practitioner > 6 months before the Screening Visit, and blood pressure (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), stable for 28 days
• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 3 patient groups, including a placebo group

IW-1973 QD/QD

Experimental group

Description:

On Days 1-14: IW-1973 40 mg taken once daily (QD) in morning (AM) and placebo taken QD at night (PM).

Treatment:

Drug: IW-1973

Drug: Placebo

IW-1973 BID (Twice Daily)/QD

Experimental group

Description:

On Days 1-7: IW-1973 20 mg taken in AM and IW-1973 20 mg taken in PM. On Days 8-14: IW-1973 40 mg taken QD in AM and placebo taken QD in PM.

Treatment:

Drug: IW-1973

Drug: Placebo

Placebo

Placebo Comparator group

Description:

On Days 1-14: Placebo taken in AM and in PM.

Treatment:

Drug: Placebo