NCT03545438 (LIB003SAD) is a Phase 1 clinical trial of LIB003 in Hypercholesterolemia, sponsored by LIB Therapeutics LLC.

Who is sponsoring NCT03545438?

NCT03545438 is sponsored by LIB Therapeutics LLC.

What drugs are being tested in NCT03545438?

Interventions in NCT03545438: LIB003.

What condition does NCT03545438 study?

NCT03545438 studies Hypercholesterolemia.

Is NCT03545438 still recruiting?

NCT03545438 is currently completed. Last updated 27 July 2018.

Last reviewed 2018-07-27 · How we verify

NCT03545438: LIB003SAD

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

Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003

Completed Phase 1 Last updated 27 July 2018

What this trial tests

Phase 1 trial testing LIB003 in Hypercholesterolemia in 63 participants. Completed in 30 June 2018.

Timeline

30 October 2017

Primary endpoint
30 May 2018

30 June 2018

Quick facts

Lead sponsor	LIB Therapeutics LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	63
Start date	30 October 2017
Primary completion	30 May 2018
Estimated completion	30 June 2018
Sites	1 location across United States

Drugs / interventions tested

LIB003 — full drug profile →

Conditions studied

Hypercholesterolemia — all drugs for Hypercholesterolemia →

Sponsor

LIB Therapeutics LLC — full company profile →

Who can join

Adults 18 to 70, any sex, with Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The evolving landscape of PCSK9 inhibition in cancer.
Oza PP, Kashfi K. · · 2023 · cited 32× · PMID 37059376 · DOI 10.1016/j.ejphar.2023.175721

Verify or expand the search:

Other trials of LIB003

Trials testing the same drug.

NCT03847974 — Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003 · Phase 2 · completed
NCT03549260 — Study to Evaluate Efficacy and Safety of LIB003 in Patients on Lipid-Lowering Therapy Needing Additional LDL-C Reduction · Phase 2 · completed

Other recruiting trials for Hypercholesterolemia

Currently open trials in the same condition.

NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
NCT07374861 — Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy · recruiting
NCT07295327 — Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia · NA · recruiting
NCT06568601 — Pharmacogenomic Informed Statin Prescribing · NA · recruiting
NCT06423365 — A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication. · NA · active not recruiting

Other LIB Therapeutics LLC trials

Trials by the same sponsor.

NCT07102511 — Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Chil · Phase 3 · not yet recruiting
NCT05004675 — Trial to Evaluate Efficacy and Safety of LIB003 and Inclisiran in High-risk CVD Patients · Phase 3 · completed
NCT05234775 — Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product · Phase 3 · completed
NCT04790513 — Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients · Phase 3 · completed
NCT04797247 — Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction · Phase 3 · unknown

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 NCT03545438 (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 LIB Therapeutics LLC
Last refreshed: 27 July 2018

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/NCT03545438.

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