A Study to Evaluate ALN-AGT01 in Patients With Hypertension

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of subcutaneous (SC) ALN-AGT01 in participants with hypertension. The study will be conducted in 4 parts: Part A will be a single ascending dose (SAD) phase in hypertensive participants, Part B will be a single dose (SD) phase in hypertensive participants with controlled salt intake, Part D will be a MD phase in hypertensive participants who are obese, and Part E will be an open-label SD phase with co-administration of irbesartan in hypertensive patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alnylam Pharmaceuticals
• Treatments: Irbesartan

Criteria

Inclusion Criteria:

• Has mild to moderate hypertension with mean sitting systolic blood pressure (SBP) of >130 and ≤165 mmHg without hypertensive medication for Parts A, B and D, and >135 and ≤165 mmHg without hypertensive medication for Part E

• Parts A and B: Has body mass index (BMI) ≥18 and ≤35 kg/m^2; Part D: Has BMI >35 and ≤50 kg/m^2; Part E: Has BMI ≥18 kg/m^2 and ≤50 kg/m^2

• Has a normal 12-lead electrocardiogram (ECG)

• Is a nonsmoker

Exclusion Criteria:

• Has secondary hypertension

• Has orthostatic hypotension

• Has estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m^2

• Recently received an investigational agent

• Has diabetes mellitus

• Has history of any cardiovascular event

• Has history of intolerance to SC injection(s)