Hypercholesterolemia
Conditions
Brief summary
To assess the longer term safety, tolerability, and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W)
Detailed description
To assess the longer term safety, tolerability, immunogenicity, PK, PD and LDL C lowering efficacy after 52 weeks of additional treatment with LIB003 with subcutaneous (SC) dosing every 4 weeks (Q4W) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial LIB003-002
Interventions
DRUGLIB003
300 mg SC Q4W
Sponsors
LIB Therapeutics LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. men and women 18 years or older 2. Elevated LDL-C on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (CVD) event or evidence of CVD or without CVD but at high risk for CVD based on American Heart Association/American College of Cardiology (AHA/ACC) CVD risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment LDL-C 190 mg/dL or greater or heterozygous familial hypercholesterolemia (HeFH) 3. patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002)
Exclusion criteria
1. patients who did not who complete the double-blind, placebo-controlled 16-week Phase 2 study (LIB003-002) 2. \<18 years of age 3. pregnant or women of childbearing potential not using acceptable birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 52 weeks | safety and tolerability will be based on the incidence and severity of treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in LDL-C at 52 Weeks | 52 weeks | percent change in serum LDL-C from baseline at 52 weeks |
Countries
United States
Participant flow
Recruitment details
4 clinical centers in USA, recruitment from patients completing a phase 2 dose ranging trial (LIB003-002)
Pre-assignment details
patients who had completed the phase 2 dose ranging trial were eligible for this open label extension trial.
Participants by arm
| Arm | Count |
|---|---|
| LIB003 LIB003
LIB003: 300 mg SC Q4W | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | relocated out of region | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | LIB003 |
|---|---|
| Age, Continuous | 63.1 years |
| BMI | 30.08 kg/m^2 |
| Race/Ethnicity, Customized African-American | 7 Participants |
| Race/Ethnicity, Customized White | 25 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 28 / 32 |
| serious Total, serious adverse events | 3 / 32 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
safety and tolerability will be based on the incidence and severity of treatment emergent adverse events
Time frame: 52 weeks
Population: SAE
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LIB003 (Lerodalcibep) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | SAE | 3 Participants |
| LIB003 (Lerodalcibep) | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | ISRs | 5 Participants |
Secondary
Percent Change in LDL-C at 52 Weeks
percent change in serum LDL-C from baseline at 52 weeks
Time frame: 52 weeks
Population: Intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LIB003 (Lerodalcibep) | Percent Change in LDL-C at 52 Weeks | 64.1 percentage from baseline | Standard Deviation 17.4 |