muvalaplin (LY3473329) / Eli Lilly

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April 24, 2024

Elevated Lipoprotein(a) Levels: A Crucial Determinant of Cardiovascular Disease Risk and Target for Emerging Therapies. (PubMed, Curr Probl Cardiol) - "Newly emerging therapies, including pelacarsen, zerlasiran, olpasiran, muvalaplin, and lepodisiran, show promise in significantly lowering Lp(a) levels, potentially transforming the management of cardiovascular disease. However, further research is essential to assess these novel therapies' long-term efficacy and safety, heralding a new era in cardiovascular disease prevention and treatment and providing hope for at-risk patients."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Hematological Disorders • Inflammation • Thrombosis

April 19, 2024

A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed

April 02, 2024

A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Eli Lilly and Company

New P1 trial

March 28, 2024

Lipoprotein(a) and Atherosclerotic Cardiovascular Disease: Where Do We Stand? (PubMed, Int J Mol Sci) - "In particular, we discuss novel agents, such as antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs) that are currently being developed and target Lp(a). The promising role of muvalaplin, an oral inhibitor of Lp(a) formation, is then further analyzed."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Hematological Disorders • Inflammation • Thrombosis

March 28, 2024

KRAKEN: A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=233 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Familial Hypercholesterolemia

January 26, 2024

KRAKEN: A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=233 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Familial Hypercholesterolemia

January 09, 2024

A Study of LY3473329 in Participants With Impaired and Normal Renal Function (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Dec 2023 ➔ Oct 2024 | Trial primary completion date: Dec 2023 ➔ Oct 2024

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

January 09, 2024

Potential of muvalaplin as a lipoprotein(a) inhibitor. (PubMed, Expert Opin Investig Drugs) - No abstract available

Journal

November 18, 2023

Highlights of Cardiovascular Disease Prevention Studies Presented at the 2023 European Society of Cardiology Congress. (PubMed, Curr Atheroscler Rep) - "Safety and efficacy data of inclisiran, a PCSK9-interfering mRNA (PCSK9i) administered subcutaneously twice annually, were presented. Data on two new PCSK9is were presented, recaticimab, an oral drug, and lerodalcibep, a subcutaneous drug with a slightly different architecture than currently available PSCK9is. A phase 1 trial on muvalaplin, an oral lipoprotein (a) inhibitor, was presented...Long-term follow-up of patients enrolled in the CLEAR outcomes trial showed sustained and more significant ASCVD risk reduction with bempedoic acid in high-risk patients. The late-breaking clinical science at the 2023 congress of the ESC extends the known safety and efficacy data of a PCSK9i with the introduction of new drugs in this class. Using cumulative exposure to LDL-C rather than a single value will help clinicians tailor the LDL-C reduction strategy to individual risk and is an important step towards personalized medicine."

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia

July 07, 2023

Muvalaplin, a Potent Small Molecule Inhibitor of Lipoprotein(a) (ESC 2023) - No abstract available

Late-breaking abstract • Cardiovascular

August 29, 2023

Muvalaplin, an Oral Small Molecule Inhibitor of Lipoprotein(a) Formation: A Randomized Clinical Trial. (PubMed, JAMA) - P1 | "Longer and larger trials will be required to further evaluate safety, tolerability, and effect of muvalaplin on Lp(a) levels and cardiovascular outcomes. ClinicalTrials.gov Identifier: NCT04472676."

Clinical • Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • APOB

May 14, 2023

Discovery and preclinical development of LY3473329, a potent small molecule inhibitor of lipoprotein(a) formation (ESC 2023) - "LY3473329 is a potent and selective small molecule inhibitor of Lp(a) formation and is the only orally administered Lp(a) investigational therapeutic in clinical development."

Preclinical • Cardiovascular • Dyslipidemia • APOB

April 13, 2023

A Study of LY3473329 in Participants With Impaired and Normal Renal Function (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Nephrology • Renal Disease

March 21, 2023

A Study of LY3473329 in Participants With Impaired and Normal Renal Function (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial • Nephrology • Renal Disease

December 08, 2022

KRAKEN: A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=233 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Familial Hypercholesterolemia • APOB • CRP

October 03, 2022

KRAKEN: A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=233 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Cardiovascular • Familial Hypercholesterolemia • APOB • CRP

June 21, 2022

A Study of LY3473329 in Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion

March 22, 2022

A Study of LY3473329 in Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed

December 14, 2021

A Study of LY3473329 in Healthy Participants (clinicaltrials.gov) - P1; N=86; Completed; Sponsor: Eli Lilly and Company; Recruiting ➔ Completed

Clinical • Trial completion

November 17, 2021

A Study of LY3473329 in Healthy Japanese Participants (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

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muvalaplin (LY3473329) / Eli Lilly - LARVOL DELTA (2024)

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Hematological Disorders • Inflammation • Thrombosis

A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Eli Lilly and Company

New P1 trial

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia • Hematological Disorders • Inflammation • Thrombosis

KRAKEN: A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=233 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Familial Hypercholesterolemia

KRAKEN: A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=233 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Familial Hypercholesterolemia

A Study of LY3473329 in Participants With Impaired and Normal Renal Function (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Dec 2023 ➔ Oct 2024 | Trial primary completion date: Dec 2023 ➔ Oct 2024

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

Potential of muvalaplin as a lipoprotein(a) inhibitor. (PubMed, Expert Opin Investig Drugs) - No abstract available

Journal

Journal • Review • Atherosclerosis • Cardiovascular • Dyslipidemia

Muvalaplin, a Potent Small Molecule Inhibitor of Lipoprotein(a) (ESC 2023) - No abstract available

Late-breaking abstract • Cardiovascular

Clinical • Journal • Atherosclerosis • Cardiovascular • Dyslipidemia • APOB

Preclinical • Cardiovascular • Dyslipidemia • APOB

A Study of LY3473329 in Participants With Impaired and Normal Renal Function (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Nephrology • Renal Disease

A Study of LY3473329 in Participants With Impaired and Normal Renal Function (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial • Nephrology • Renal Disease

KRAKEN: A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=233 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Familial Hypercholesterolemia • APOB • CRP

KRAKEN: A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (clinicaltrials.gov) - P2 | N=233 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Cardiovascular • Familial Hypercholesterolemia • APOB • CRP

A Study of LY3473329 in Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion

A Study of LY3473329 in Healthy Japanese Participants (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of LY3473329 in Healthy Participants (clinicaltrials.gov) - P1; N=86; Completed; Sponsor: Eli Lilly and Company; Recruiting ➔ Completed

Clinical • Trial completion

A Study of LY3473329 in Healthy Japanese Participants (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open