AZD3427 / AstraZeneca - LARVOL DELTA

AZD3427, a novel relaxin receptor agonist and impact on renal perfusion in patients with heart failure with reduced ejection rraction: the phase 1b Re-Perfuse study design (HEART FAILURE 2025) - No abstract available

Clinical • P1 data • Cardiovascular • Congestive Heart Failure • Heart Failure

A novel long-acting relaxin-2 fusion, AZD3427, improves cardiac performance in non-human primates with cardiac dysfunction. (PubMed, Cardiovasc Res) - "Prolonged administration of AZD3427, a long-acting relaxin receptor RXFP1 agonist, resulted in remarkable improvement in cardiac function in a NHP model. Findings of this study are an important translational step to developing future therapies and support further clinical development of AZD3427 as a novel treatment for patients with heart failure (HF)."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Metabolic Disorders

Re-PHIRE: A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2 (clinicaltrials.gov) - P2 | N=245 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Relaxin mimetic in pulmonary hypertension associated with left heart disease: Design and rationale of Re-PHIRE. (PubMed, ESC Heart Fail) - "Re-PHIRE is the first study of a relaxin mimetic in patients with PH-LHD. The insights gained from the Re-PHIRE study are expected to inform the further development of AZD3427 in the PH-LHD population, including identifying the most suitable pulmonary hypertension and HF phenotypes for treatment."

Clinical • Journal • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Fibrosis • Heart Failure • Hypertension • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Re-PERFUSE: AZD3427 Effects on Renal Perfusion in Heart Failure Patients With Reduced Ejection Fraction and Renal Impairment (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure • Renal Disease

Re-PERFUSE: AZD3427 Effects on Renal Perfusion in Heart Failure Patients With Reduced Ejection Fraction and Renal Impairment (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Renal Disease

Novel Relaxin Receptor RXFP1 Agonist AZD3427 in the Treatment of Heart Failure: A Phase 1a/b, First-in-Human, Randomized, Single-Blind, Placebo-Controlled Study. (PubMed, J Am Heart Assoc) - P1 | "AZD3427 had favorable safety and pharmacokinetic profiles. Hemodynamic changes in patients with heart failure were consistent with the anticipated effects of a relaxin analog. These findings support further development of AZD3427 as a novel long-term treatment for patients with heart failure."

Journal • P1 data • Cardiovascular • Congestive Heart Failure • Heart Failure

AZD3427, a relaxin mimetic in pulmonary hypertension group 2 associated with left heart disease: design and rationale of the phase 2b Re-PHIRE Study (HEART FAILURE 2024) - "Re-PHIRE is the first study of a relaxin mimetic in PH-LHD. Insights gained from this study are expected to inform the further development of AZD3427 in the PH-LHD population."

P2b data • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension

Re-PHIRE: A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2 (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: AstraZeneca | Phase classification: P2b ➔ P2

Phase classification • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Safety, pharmacokinetics, and pharmacodynamics of AZD3427, a functionally selective long acting relaxin mimetic agonist of the RXFP1 receptor (HEART FAILURE 2023) - "AZD3427 was generally well tolerated. These findings support further evaluation of AZD3427 in patients with HF."

Clinical • PK/PD data • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypotension

Re-PHIRE: A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2 (clinicaltrials.gov) - P2b | N=220 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CST3

Re-PHIRE: A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2 (clinicaltrials.gov) - P2b | N=220 | Not yet recruiting | Sponsor: AstraZeneca

New P2b trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CST3

Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427 (clinicaltrials.gov) - P1 | N=105 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427 (clinicaltrials.gov) - P1 | N=105 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427 (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: AstraZeneca | Trial completion date: May 2022 ➔ Aug 2022 | Trial primary completion date: May 2022 ➔ Aug 2022

Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: AstraZeneca; N=16 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Cardiovascular • Congestive Heart Failure • Heart Failure

Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: AstraZeneca; Trial completion date: Mar 2022 ➔ Aug 2022; Trial primary completion date: Mar 2022 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427 (clinicaltrials.gov) - P1; N=104; Recruiting; Sponsor: AstraZeneca; Trial completion date: Oct 2021 ➔ May 2022; Trial primary completion date: Oct 2021 ➔ May 2022

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • NPPB

Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: AstraZeneca; Trial completion date: Nov 2021 ➔ Mar 2022; Initiation date: Jun 2021 ➔ Oct 2021; Trial primary completion date: Nov 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

Study to Evaluate the Effects of AZD3427 in Patients With Heart Failure (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: AstraZeneca

Clinical • New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427 (clinicaltrials.gov) - P1; N=104; Recruiting; Sponsor: AstraZeneca; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427 (clinicaltrials.gov) - P1; N=104; Not yet recruiting; Sponsor: AstraZeneca

Clinical • New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure