NCT03934307 is a Phase 1 clinical trial of ALN-AGT01 in Hypertension, sponsored by Alnylam Pharmaceuticals.

Who is sponsoring NCT03934307?

NCT03934307 is sponsored by Alnylam Pharmaceuticals.

What drugs are being tested in NCT03934307?

Interventions in NCT03934307: ALN-AGT01, ALN-AGT01-Matching Placebo, Irbesartan, Irbesartan-Matching Placebo.

What condition does NCT03934307 study?

NCT03934307 studies Hypertension.

Is NCT03934307 still recruiting?

NCT03934307 is currently completed. Last updated 17 January 2023.

Last reviewed 2023-01-17 · How we verify

NCT03934307

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate ALN-AGT01 in Patients With Hypertension

Completed Phase 1 Last updated 17 January 2023

What this trial tests

Phase 1 trial testing ALN-AGT01 in Hypertension in 124 participants. Completed in 4 January 2023.

Timeline

1 May 2019

Primary endpoint
20 April 2022

4 January 2023

Quick facts

Lead sponsor	Alnylam Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	124
Start date	1 May 2019
Primary completion	20 April 2022
Estimated completion	4 January 2023
Sites	3 locations across United Kingdom

Drugs / interventions tested

ALN-AGT01 — full drug profile →
ALN-AGT01-Matching Placebo — full drug profile →
Irbesartan (IRBESARTAN) — full drug profile →
Irbesartan-Matching Placebo — full drug profile →

Conditions studied

Hypertension — all drugs for Hypertension →

Sponsor

Alnylam Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of subcutaneous (SC) ALN-AGT01 (zilebesiran) 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Therapeutic siRNA: state of the art.
Hu B, Zhong L, Weng Y, Peng L, et al · · 2020 · cited 991× · PMID 32561705 · DOI 10.1038/s41392-020-0207-x
Zilebesiran, an RNA Interference Therapeutic Agent for Hypertension.
Desai AS, Webb DJ, Taubel J, Casey S, et al · · 2023 · cited 184× · PMID 37467498 · DOI 10.1056/nejmoa2208391
Paving the Road for RNA Therapeutics.
Dammes N, Peer D. · · 2020 · cited 159× · PMID 32893005 · DOI 10.1016/j.tips.2020.08.004
The landscape of nanoparticle-based siRNA delivery and therapeutic development.
Moazzam M, Zhang M, Hussain A, Yu X, et al · · 2024 · cited 116× · PMID 38204162 · DOI 10.1016/j.ymthe.2024.01.005
The Progress and Promise of RNA Medicine─An Arsenal of Targeted Treatments.
Sasso JM, Ambrose BJB, Tenchov R, Datta RS, et al · · 2022 · cited 69× · PMID 35533054 · DOI 10.1021/acs.jmedchem.2c00024
Landscape of small nucleic acid therapeutics: moving from the bench to the clinic as next-generation medicines.
Liu M, Wang Y, Zhang Y, Hu D, et al · · 2025 · cited 62× · PMID 40059188 · DOI 10.1038/s41392-024-02112-8
RNA interference therapeutics targeting angiotensinogen ameliorate preeclamptic phenotype in rodent models.
Haase N, Foster DJ, Cunningham MW, Bercher J, et al · · 2020 · cited 33× · PMID 32338644 · DOI 10.1172/jci99417
The renin-angiotensin system biomolecular cascade: a 2022 update of newer insights and concepts.
Ferrario CM, Groban L, Wang H, Sun X, et al · · 2022 · cited 32× · PMID 35529089 · DOI 10.1016/j.kisu.2021.11.002

Verify or expand the search:

Other trials of ALN-AGT01

Trials testing the same drug.

NCT04936035 — A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension · Phase 2 · completed

Other recruiting trials for Hypertension

Currently open trials in the same condition.

NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S · recruiting
NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting

Other Alnylam Pharmaceuticals trials

Trials by the same sponsor.

NCT07535606 — A Study to Evaluate ALN-4915 in Adult Healthy Volunteers · Phase 1 · recruiting
NCT07463846 — A Study to Evaluate ALN-2232 in Participants With Obesity · Phase 1, PHASE2 · recruiting
NCT07223203 — TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidos · Phase 3 · recruiting
NCT07465224 — A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus · Phase 2 · recruiting
NCT07358078 — DemonsTTRate: A Global, Observational, Multicenter, Long-term Study of Patients With ATTR-CM in a Real-World Setting · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03934307 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alnylam Pharmaceuticals
Last refreshed: 17 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03934307.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing