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Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

lerodalcibep

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Provision of written and signed informed consent prior to any study-specific procedure
LDL-C 70 mg/dL or above on stable diet alone or diet plus statin
Weight of 40 kg (88 lb) and body mass index (BMI) between 17 and 42 kg/m2
Females of childbearing potential must be using a highly effective form of birth control
Male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control

Exclusion Criteria:

Fasting triglyceride >400 mg/dL
excluded lipid lowering medication
severe renal impairment (eGFR <30 ml/min)
fasting glucose >200 mg/dL plus HbA1c >9%
hepatic transaminases >2.5 x ULN for laboratory
History of any prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion, at the discretion of the Investigator,
NYHA class III-IV heart failure or last documented left ventricular EF <30%
Any severe or clinically significant advert event, laboratory abnormality, intercurrent illness, or other medical condition which indicates to the Investigator that continued participation is not in the best interest of the subject

Sites / Locations

Metabolic & Atherosclerosis Research Center (MARC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LIB003 (lerodalcibep) Process 1

LIB003 (lerodalcibep) Process 2

Arm Description

300 mg LIB003 Process 1 drug product administered SC

300 mg LIB003 Process 2 drug product administered SC

Outcomes

Primary Outcome Measures

pharmacodynamics

comparison of free PCSK9 reductions from baseline between P1 and P2

Cmax pharmacokinetics

comparison of serum lerodalcibep Cmax between P1 and P2

AUC 0-last pharmacokinetics

comparison of serum lerodalcibep AUC 0-last between P1 and P2

T-Half pharmacokinetics

comparison of serum lerodalcibep T-HALF between P1 and P2

Secondary Outcome Measures

comparison of LDL-C

comparison of serum LDL-C reductions from baseline to week 4 between P1 and P2

Full Information

NCT ID

NCT05234775

First Posted

January 17, 2022

Last Updated

July 13, 2022

Sponsor

LIB Therapeutics LLC

Collaborators

Medpace, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05234775

Brief Title

Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product

Official Title

Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product in Subjects With or Without Statin Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

January 28, 2022 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

July 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LIB Therapeutics LLC

Collaborators

Medpace, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare the pharmacokinetics (PK), and pharmacodynamics (PD) of single subcutaneous (SC) doses of 300 mg LIB003 Process 1 (P1) and Process 2 (P2) drug product in subjects with or without statin therapy

Detailed Description

Comparison of the pharmacokinetics (PK), and pharmacodynamics (free PCSK9 and LDL-C) of single subcutaneous (SC) doses of 300 mg of both LIB003 drug product manufactured by Process 1 (P1) and Process 2 (P2) in subjects with or without statin therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Model Description

assignment to initial treatment group with cross over to alternate treatment group

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LIB003 (lerodalcibep) Process 1

Arm Type

Experimental

Arm Description

300 mg LIB003 Process 1 drug product administered SC

Arm Title

LIB003 (lerodalcibep) Process 2

Arm Type

Active Comparator

Arm Description

300 mg LIB003 Process 2 drug product administered SC

Intervention Type

Drug

Intervention Name(s)

lerodalcibep

Other Intervention Name(s)

LIB003

Intervention Description

300 mg of each drug given SC as single dose

Primary Outcome Measure Information:

Title

pharmacodynamics

Description

comparison of free PCSK9 reductions from baseline between P1 and P2

Time Frame

4 weeks

Title

Cmax pharmacokinetics

Description

comparison of serum lerodalcibep Cmax between P1 and P2

Time Frame

4 weeks

Title

AUC 0-last pharmacokinetics

Description

comparison of serum lerodalcibep AUC 0-last between P1 and P2

Time Frame

4 weeks

Title

T-Half pharmacokinetics

Description

comparison of serum lerodalcibep T-HALF between P1 and P2

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

comparison of LDL-C

Description

comparison of serum LDL-C reductions from baseline to week 4 between P1 and P2

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of written and signed informed consent prior to any study-specific procedure LDL-C 70 mg/dL or above on stable diet alone or diet plus statin Weight of 40 kg (88 lb) and body mass index (BMI) between 17 and 42 kg/m2 Females of childbearing potential must be using a highly effective form of birth control Male subjects will either be surgically sterile or agree, or partner agrees, to use highly effective form of birth control Exclusion Criteria: Fasting triglyceride >400 mg/dL excluded lipid lowering medication severe renal impairment (eGFR <30 ml/min) fasting glucose >200 mg/dL plus HbA1c >9% hepatic transaminases >2.5 x ULN for laboratory History of any prior or active clinical condition or acute and/or unstable systemic disease compromising subject inclusion, at the discretion of the Investigator, NYHA class III-IV heart failure or last documented left ventricular EF <30% Any severe or clinically significant advert event, laboratory abnormality, intercurrent illness, or other medical condition which indicates to the Investigator that continued participation is not in the best interest of the subject

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Traci A Turner, MD

Organizational Affiliation

Metabolic & Atherosclerosis Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Metabolic & Atherosclerosis Research Center (MARC)

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cross-Over Study to Compare the Pharmacokinetics and Pharmacodynamics of LIB003 Process 1 and Process 2 Drug Product

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