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A Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacodynamics, and Pharmacokinetics of Zilebesiran in Japanese Patients with Mild to Moderate Hypertension

A Study to Evaluate Zilebesiran in Japanese Patients with Mild to Moderate Hypertension

Ozone Yuriko

CMIC Co., Ltd.

2-2-7, Nakanoshima, Kita-ku, Osaka

ClinicalTrialInformation@cmic.co.jp

Ozone Yuriko

CMIC Co., Ltd.

2-2-7, Nakanoshima, Kita-ku, Osaka

+81-80-1180-2132

ClinicalTrialInformation@cmic.co.jp

Complete

June. 07, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1.18 Years to 75 Years (Adult, Older Adult)
2.Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin.
3.Has untreated hypertension or newly diagnosed with hypertension (not taking antihypertensive medication) or is on stable therapy with up to 2 antihypertensive medications.
4.Mean sitting SBP of >130 and =<165 mmHg by automated office blood pressure measurement, with a minimum of 3 week washout prior to office blood pressure measurement.
5.24-hour mean SBP >=130 mmHg by ABPM, after a minimum of 3 weeks washout if taking hypertensive medication.

1.Secondary hypertension
2.History of orthostatic hypotension or orthostatic hypotension during screening
3.ALT or AST >2 x ULN
4.Elevated serum potassium >5 mmol/L.
5.eGFR of <60 mL/min/1.73m2 (calculation will be based on the Modification of Diet in Renal Disease formula with a Japanese coefficient of 0.808).
6.Received an investigational agent within the last 30 days before randomization or are in follow-up of another clinical study prior to study enrollment.
7.Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus (hemoglobin A1c:HbA1c >9.0%), or laboratory evidence of diabetes during screening (HbA1c >=7.0%) without known diagnosis of diabetes.
8.History of any cardiovascular event
9.History of intolerance to SC injection(s)

Both

Mild to Moderate Hypertension

Patients will be administered a single dose of zilebesiran or placebo as an SC injection on Day 1.

High blood pressure, Hypertension, Hypertensive, SiRNA, Angiotensinogen, AGT

Frequency of Adverse Events (AEs)

1.Percent Change from Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6
2.Change from Baseline at Month 3 and Month 6 in 24-hour Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
3.Change from Baseline at Month 3 and Month 6 in SBP and DBP Assessed by Office Blood Pressure
4.Maximum Observed Plasma Concentration (Cmax) of Zilebesiran Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Zilebisiran: Fraction of Zilebisiran Excreted in the Urine (fe)

+81-92-283-7701

May. 09, 2024

No

none