Phase 2 Completed N=378 Randomized Quadruple-blind Treatment

A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension

Hypertension

Source: ClinicalTrials.gov NCT04936035 ↗

Enrolled (actual)

378

Serious AEs

5.9%

Results posted

Dec 2024

Primary outcomePrimary: Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM — 6.8; -7.3; -10.0; -8.9 millimeters of mercury (mmHg) — p=<0.0001

Summary

The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline at Month 3 in 24-hour Mean SBP Assessed by ABPM	6.8; -7.3; -10.0; -8.9	<0.0001 sig
SECONDARY Change From Baseline at Month 3 in Mean Sitting Office SBP	-0.1; -9.7; -12.1; -9.2	<0.0001 sig
SECONDARY Change From Baseline at Month 6 in 24-hour Mean SBP Assessed by ABPM	4.6; -6.5; -9.9; -9.5; -9.6	<0.0001 sig
SECONDARY Change From Baseline at Month 6 in Mean Sitting Office SBP	-0.6; -8.2; -11.1; -12.8; -10.8	<0.0001 sig
SECONDARY Percentage of Participants With 24-hour Mean SBP Assessed by ABPM <130 mmHg and/or Reduction of ≥20 mmHg From Baseline Without Additional Antihypertensive Medications at Month 6	6.7; 30.8; 50.7; 38.7; 47.4	<0.0001 sig
SECONDARY Change From Baseline at Month 3 in 24-hour Mean DBP Assessed by ABPM	3.5; -4.5; -5.7; -5.8	—
SECONDARY Change From Baseline at Month 6 in 24-hour Mean DBP Assessed by ABPM	2.2; -4.8; -6.1; -6.3; -6.3	—
SECONDARY Change From Baseline at Month 3 in Mean Sitting Office DBP	-0.6; -5.3; -7.0; -5.4	—
SECONDARY Time Adjusted Change From Baseline Through Month 3 in Mean Sitting Office SBP and DBP	-0.6; -9.1; -10.9; -10.1; -0.0; -4.8	—
SECONDARY Change From Baseline at Month 6 in Mean Sitting Office DBP	-1.2; -4.1; -6.8; -8.2; -5.0	—
SECONDARY Time Adjusted Change From Baseline Through Month 6 in 24-hour Mean SBP and DBP Assessed by ABPM	5.8; -6.3; -9.2; -9.6; -9.1; 3.1	—
SECONDARY Time Adjusted Change From Baseline Through Month 6 in Mean Sitting Office SBP and DBP	-0.5; -9.0; -12.1; -11.0; -10.0; -0.6	—
SECONDARY Change From Baseline in Daytime/Nighttime Mean SBP and DBP Assessed by ABPM at Each Visit	4.3; -3.6; -6.4; -9.6; -9.1; 6.7	—
SECONDARY Percentage Change From Baseline in Serum Angiotensinogen (AGT) Through Month 6	-0.05; -88.34; -92.68; -92.77; -94.49; 1.61	—

Eligibility Criteria

Inclusion Criteria

Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication

Exclusion Criteria

Secondary hypertension, orthostatic hypotension
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN)
Elevated potassium >5 mEq/L
Estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m^2
Received an investigational agent within the last 30 days
Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus
History of any cardiovascular event within 6 months prior to randomization
History of intolerance to SC injection(s)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04936035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.