Clinical Trials

Multiple clinical trials sponsored by Eli Lilly and Company evaluate the safety, pharmacokinetics, and therapeutic efficacy of muvalaplin (LY3473329). Early-phase development includes completed and active Phase 1 trials assessing ascending doses, bioavailability, and disposition in healthy subjects and individuals with renal insufficiency. Further evaluation features a completed Phase 2 trial in lipoprotein disorders and an actively recruiting Phase 3 trial investigating cardiovascular event reduction in patients with elevated lipoprotein(a) and atherosclerotic cardiovascular disease.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07157774 RECRUITING
Elevated Lp(a); Atherosclerotic Cardiovascular Disease (ASCVD)
Eli Lilly and Company
 2025-09-02 PHASE3
NCT05778864 COMPLETED
Renal Insufficiency
Eli Lilly and Company
 2023-03-17 PHASE1
NCT06342596 COMPLETED
Healthy
Eli Lilly and Company
 2024-03-05 PHASE1
NCT05563246 COMPLETED
Lipoprotein Disorder
Eli Lilly and Company
 2022-11-24 PHASE2
NCT06342596 Active not recruiting
Healthy
Eli Lilly and Company
 2024-03-05 Phase 1
NCT05778864 Recruiting
Renal Insufficiency
Eli Lilly and Company
 2023-03-17 Phase 1
NCT05563246 Completed
Lipoprotein Disorder
Eli Lilly and Company
 2022-11-24 Phase 2
NCT05038787 COMPLETED
Healthy
Eli Lilly and Company
 2021-11-11 PHASE1
NCT04472676 COMPLETED
Healthy
Eli Lilly and Company
 2020-08-18 PHASE1
NCT05038787 Completed
Healthy
Eli Lilly and Company
 2021-11-11 Phase 1
NCT04472676 Completed
Healthy
Eli Lilly and Company
 2020-08-18 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Muvalaplin(LY3473329) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Muvalaplin (LY3473329) selectively inhibits lipoprotein(a) formation by disrupting the specific interaction between apolipoprotein(a) and apolipoprotein B100. By blocking this initial assembly step, the compound prevents the generation of pathogenic lipoprotein(a) particles, offering a targeted approach to attenuate elevated lipoprotein(a) levels in patients with lipoprotein disorders and atherosclerotic cardiovascular disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.