A Study on Efficacy and Safety of HST101 in Chinese Patients With Hypercholesterolemia
NCT Number: NCT06568471
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Hypercholesterolemia|Dyslipidemias|Primary Hypercholesterolemia|Heterozygous Familial Hypercholesterolemia|Hyperlipidemia; Mixed|Metabolic Disease|ASCVD
Interventions: DRUG: Lerodalcibep|DRUG: matching placebo
Sponsor: Hasten Biopharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-05
Locations: Peking University First Hospital, Beijing, 100034, China

Summary:
This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W \[≤31 days\]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high/high risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.

Primary Outcome Measures: LDL-C change compared to Placebo, Percent change in LDL-C level from baseline (calculated by Friedewald formula) compared to Placebo, 12 weeks|Mean LDL-C change at Weeks 10 and 12 compared to Placebo, Percent change in mean LDL-C level from baseline (calculated by Friedewald formula) compared to placebo at Weeks 10 and 12, 12 weeks
Secondary Outcome Measures: LDL-C change over time, Absolute and percent change in LDL-C level from baseline at Weeks 4, 8, 10, and 12, 12 weeks|Free PCSK9 change, Absolute and Percent change in serum free PCSK9 level from baseline at Weeks 4,8 and 12, 12 weeks|Other Lipid parameters change, Absolute and Percent change in TC, TG, HDL-C, non-HDL-C, VLDL-C, Apo B and Lp(a) from baseline at Weeks 4,8 and 12, 12 weeks|Percentage of patients achieving LDL-C goals recommended by 2023 Chinese guideline, To assess the effect of HST101 on the percentage of patients achieving LDL-C\<2.6 mmol/L (high-risk for ASCVD patients), LDL-C\<1.8 mmol/L and \>50% reduction from baseline (very-high risk for ASCVD patients), LDL-C\<1.4 mmol/L and \>50% reduction from baseline (ultra-high risk for ASCVD patients), 12 weeks|Incidence of treatment-emergent adverse events, Evaluation of adverse events, clinical lab tests, 12-lead ECG, vital signs, injection site reactions (ISRs), 52 weeks
Other Outcome Measures: Long time free PCSK9 change, Absolute and percent change in serum free PCSK9 levels from baseline at Weeks 16,20,24,36,48 and 52, 52 weeks|Long time LDL-C change, Absolute and percent change in LDL-C level from baseline at Weeks 16,20,22,24,36,48,50 and 52, 52 weeks|Percentage of patients achieving LDL-C goals recommended by 2023 Chinese guideline, To assess the effect of HST101 on the percentage of patients achieving LDL-C\<2.6 mmol/L (high-risk for ASCVD patients), LDL-C\<1.8 mmol/L and \>50% reduction from baseline (very-high risk for ASCVD patients), LDL-C\<1.4 mmol/L and \>50% reduction from baseline (ultra-high risk for ASCVD patients) at Weeks 16, 20, 24, 36, 48 and 52, 52 weeks