Trial Outcomes & Findings for Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003 (NCT NCT03847974)

Results Overview

safety and tolerability will be based on the incidence and severity of treatment emergent adverse events

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

52 weeks

Results posted on

2022-03-02

Participant Flow

4 clinical centers in USA, recruitment from patients completing a phase 2 dose ranging trial (LIB003-002)

patients who had completed the phase 2 dose ranging trial were eligible for this open label extension trial.

Participant milestones

Participant milestones
Measure	LIB003 (Lerodalcibep) LIB003 (lerodalcibep) LIB003: 300 mg SC Q4W
Overall Study STARTED	32
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	LIB003 (Lerodalcibep) LIB003 (lerodalcibep) LIB003: 300 mg SC Q4W
Overall Study relocated out of region	3
Overall Study Withdrawal by Subject	2
Overall Study Adverse Event	1

Baseline Characteristics

Open-Label Extension to Evaluate the Longer Term Efficacy and Safety of LIB003

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LIB003 n=32 Participants LIB003 LIB003: 300 mg SC Q4W
Age, Continuous	63.1 years n=99 Participants
Sex: Female, Male Female	20 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Race/Ethnicity, Customized White	25 Participants n=99 Participants
Race/Ethnicity, Customized African-American	7 Participants n=99 Participants
Region of Enrollment United States	32 Participants n=99 Participants
BMI	30.08 kg/m^2 n=99 Participants

PRIMARY outcome

Timeframe: 52 weeks

Population: SAE

safety and tolerability will be based on the incidence and severity of treatment emergent adverse events

Outcome measures

Outcome measures
Measure	LIB003 (Lerodalcibep) n=32 Participants LIB003 (lerodalcibep) LIB003: 300 mg SC Q4W
Number of Participants With Treatment Emergent Adverse Events (TEAEs) SAE	3 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) ISRs	5 Participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Intent to treat

percent change in serum LDL-C from baseline at 52 weeks

Outcome measures

Outcome measures
Measure	LIB003 (Lerodalcibep) n=32 Participants LIB003 (lerodalcibep) LIB003: 300 mg SC Q4W
Percent Change in LDL-C at 52 Weeks	64.1 percentage from baseline Standard Deviation 17.4

Adverse Events

LIB003 (Lerodalcibep)

Serious events: 3 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LIB003 (Lerodalcibep) n=32 participants at risk LIB003 (lerodalcibep) LIB003: 300 mg SC Q4W
Cardiac disorders supraventricular tachycardia	3.1% 1/32 • Number of events 1 • 52 weeks
Gastrointestinal disorders small bowel obstruction	3.1% 1/32 • Number of events 1 • 52 weeks
Reproductive system and breast disorders worsening of uterine fibroids	3.1% 1/32 • Number of events 1 • 52 weeks

Other adverse events

Other adverse events
Measure	LIB003 (Lerodalcibep) n=32 participants at risk LIB003 (lerodalcibep) LIB003: 300 mg SC Q4W
General disorders Other Adverse Event	87.5% 28/32 • Number of events 64 • 52 weeks
Skin and subcutaneous tissue disorders Other (Not Including Serious) Adverse Events were not monitored/assessed using specific Adverse Even	9.4% 3/32 • Number of events 5 • 52 weeks

Additional Information

Evan A Stein MD PhD FACC

LIB Therapeutics

Phone: 18596533141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60