AZD4144 / AstraZeneca - LARVOL DELTA

A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease. (clinicaltrials.gov) - P1 | N=29 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease

SERENIA: A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury. (clinicaltrials.gov) - P2 | N=124 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Acute Kidney Injury • Infectious Disease • Nephrology • Renal Disease • Septic Shock • CST3

Safety, Tolerability, Pharmacokinetics, and Target Engagement of Single and Multiple Ascending Doses of Intravenous AZD4144, a Small Molecule NLRP3 Inhibitor for Treatment of AKI (KIDNEY WEEK 2025) - "AZD4144 demonstrated robust, dose-dependent, durable inhibition (>90%) of IL-1β and Il-18 production by PBMCs stimulated ex vivo. Conclusion AZD4144 was safe and well tolerated in healthy participants, had pharmacokinetics supporting once daily IV infusion, and displayed robust, dose-dependent inhibition of ex vivo stimulated IL-18 and IL-1b secretion."

Clinical • PK/PD data • Acute Kidney Injury • Chronic Kidney Disease • Infectious Disease • Inflammation • Nephrology • Renal Disease • IL18 • IL1B • NLRP3

Inhibition of NLRP3 Signalling Improves Kidney Function in Preclinical Models of AKI (KIDNEY WEEK 2025) - "NLRP3 inhibition significantly reduces kidney injury in preclinical models of AKI. These findings support the therapeutic potential of AZD4144 for AKI."

Preclinical • Acute Kidney Injury • Cardiovascular • Infectious Disease • Nephrology • Renal Disease • Reperfusion Injury • Septic Shock • IL18 • IL1B • NLRP3

A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion

Discovery of AZD4144, a Selective and Potent NLRP3 Inhibitor for the Treatment of Inflammatory Diseases. (PubMed, J Med Chem) - "The compound inhibits NLRP3 selectively with high potency, has beneficial pharmacokinetic properties, and shows a favorable off-target pharmacology profile. We also show that AZD4144 binds directly to NLRP3 and competes with MCC950 for binding to the protein, indicating that the likely mode of inhibition of AZD4144 is to stabilize the inactive form of NLRP3."

Journal • Cardiovascular • Infectious Disease • Inflammation • NLRP3

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin and Furosemide in Healthy Participants (clinicaltrials.gov) - P1 | N=91 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion

A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion

A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants (clinicaltrials.gov) - P1 | N=41 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed | N=24 ➔ 41

Enrollment change • Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Study to Investigate the Safety, Tolerability and Pharmacodynamics of AZD4144 in Participants With Obesity (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Genetic Disorders • Obesity

A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

A Study to Investigate How AZD4144 Affects the Pharmacokinetics of Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Mar 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease. (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease • IL6

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants (clinicaltrials.gov) - P1 | N=95 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion

A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease. (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Atherosclerosis • Cardiovascular • Chronic Kidney Disease • Dyslipidemia • Nephrology • Renal Disease • IL6

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 as Well as the Impact of AZD4144 on the Pharmacokinetics of Rosuvastatin in Healthy Participants (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open