## Protocol Section
### Identification Module
**NCT ID:** NCT06423352

**Brief Title:** A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension

**Official Title:** 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

#### Organization Study ID Info
**ID:** ALN-AGT01-006
#### Organization
**Class:** INDUSTRY
**Full Name:** Alnylam Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2025-09-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Alnylam Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics (PD) and pharmacokinetics (PK) of zilebesiran in Japanese patients with mild to moderate hypertension.

### Conditions Module

**Conditions:**

- Mild to Moderate Hypertension

**Keywords:**

- High blood pressure

- Hypertension

- Hypertensive

- siRNA

- Angiotensinogen

- AGT

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will be administered a single dose of zilebesiran.

**Intervention Names:**

- Drug: Zilebesiran

**Label:** Zilebesiran

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will be administered a single dose of placebo.

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Zilebesiran

**Description:** Zilebesiran administered by subcutaneous (SC) injection

**Name:** Zilebesiran

**Other Names:**

- ALN-AGT01

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo administered by SC injection

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Frequency of Adverse Events (AEs)

**Time Frame:** Up to 12 months

#### Secondary Outcomes

**Measure:** Percent Change from Baseline in Serum Angiotensinogen (AGT) at Month 3 and Month 6

**Time Frame:** Baseline and Month 3 and Month 6

**Measure:** 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)

**Time Frame:** Baseline and Month 3 and Month 6

**Measure:** Change from Baseline at Month 3 and Month 6 in SBP and DBP Assessed by Office Blood Pressure

**Time Frame:** Baseline and Month 3 and Month 6

**Measure:** Pharmacokinetics of Zilebesiran and its Metabolite assessed by Plasma Concentration

**Time Frame:** Predose and up to 3 days postdose

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Must have been born in Japan, and their biological parents and grandparents must have been of Japanese origin
* Has mean systolic office blood pressure (SBP) of \>130 and \<=165 mmHg by automated office blood pressure measurement, after a minimum of 3 weeks of washout if taking hypertensive medication
* Has 24-hour mean SBP ≥130 mmHg by ambulatory blood pressure monitoring (ABPM), without antihypertensive medication

Exclusion Criteria:

* Has secondary hypertension, symptomatic orthostatic hypotension
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN)
* Has elevated serum potassium \>5 mmol/L
* Has estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m\^2
* Has received an investigational agent within the last 30 days
* Has Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus or newly diagnosed Type 2 diabetes mellitus
* Has history of intolerance to SC injection(s)

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicaltrials@alnylam.com

**Name:** Alnylam Clinical Trial Information Line

**Phone:** 1-877-ALNYLAM

**Role:** CONTACT

**Contact 2:**

**Email:** clinicaltrials@alnylam.com

**Name:** Alnylam Clinical Trial Information Line

**Phone:** 1-877-256-9526

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Alnylam Pharmaceuticals

**Name:** Medical Director

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

### Intervention Browse Module - Browse Branches

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4132

- Name: Angiotensin II

- Relevance: LOW

- As Found: Unknown

- ID: M4135

- Name: Angiotensinogen

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
