Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568471
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
A Study on Efficacy and Safety of HST101 in Chinese Patients With Hypercholesterolemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients With Hypercholesterolemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-highhigh 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
Detailed Description:
This is a multi-center randomized double-blind placebo-controlled Phase 3 study Participants who fulfill the inclusion and exclusion criteria will be enrolled at up to 35 study sites in mainland China
All eligible participants will be randomized in a 21 ratio to HST101 or placebo dosed subcutaneously Q4W 31 days in the initial 12-week randomized double-blind treatment period After 12-week treatment all the participants will enter to the 36-week open-label treatment period where those who are on HST101 will continue to receive HST101 in the same dosing regimen as dosed in the randomized period and those who are on placebo will be switched to HST101 300 mg Q4W 31 days administered subcutaneously
The total study duration will be up to 55 weeks which includes a up to 3-week Screening Period 12-week randomized double-blind placebo-controlled treatment period 36-week open-label treatment period followed by a 4-week follow-up period
All eligible participants will be randomized in a 21 ratio to HST101 or placebo dosed subcutaneously Q4W 31 days in the initial 12-week randomized double-blind treatment period After 12-week treatment all the participants will enter to the 36-week open-label treatment period where those who are on HST101 will continue to receive HST101 in the same dosing regimen as dosed in the randomized period and those who are on placebo will be switched to HST101 300 mg Q4W 31 days administered subcutaneously
The total study duration will be up to 55 weeks which includes a up to 3-week Screening Period 12-week randomized double-blind placebo-controlled treatment period 36-week open-label treatment period followed by a 4-week follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None