Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
Led by Hasten Biopharmaceutical Co., Ltd. · Updated on 2025-02-06
210
Participants Needed
18
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of HST101 (lerodalcibep), a PCSK9 inhibitor, on lowering LDL cholesterol in patients with atherosclerotic cardiovascular disease or those at very high or high risk for this condition, including patients with heterozygous familial hypercholesterolemia. This is a randomized, double-blind, placebo-controlled Phase 3 study conducted in multiple centers in mainland China to assess the safety and efficacy of HST101 over a one-year period. Participants will be randomly assigned in a 2:1 ratio to receive either 300 mg of HST101 or a matching placebo by subcutaneous injection every four weeks for 12 weeks. After this initial phase, all participants will receive HST101 in an open-label treatment for 36 weeks at the same dosing schedule, followed by a 4-week safety follow-up. This study includes a screening period lasting up to 3 weeks before treatment begins. During the study, participants will have regular assessments to monitor LDL cholesterol changes, free PCSK9 levels, other lipid parameters, and any treatment-related side effects. The primary focus is the change in LDL cholesterol at week 12 compared to placebo. Safety and efficacy will be observed throughout the 52-week treatment period, including monitoring for adverse events. The total study duration for participants is up to 55 weeks, including screening and follow-up.
CONDITIONS
Brief Title
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written and signed informed consent before any study procedures
- Male or female aged 18 years or older at screening
- Body weight of at least 40 kg and BMI between 18 and 35 kg/m2
- On a stable diet and oral cholesterol-lowering drugs for at least 4 weeks before first dose
- LDL-C and triglyceride levels meeting specific thresholds for ASCVD risk groups
- Completed required washout period if previously on PCSK9 monoclonal antibody therapy
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and 3 months after the trial
You will not qualify if you...
- History of homozygous familial hypercholesterolemia (HoFH)
- Severe kidney impairment with eGFR less than 30 mL/min/1.73m2
- Active liver disease, liver transplant history, or elevated liver enzymes above 2.5 times normal
- Poorly controlled thyroid disorders
- Poorly controlled diabetes with high fasting blood glucose or HbA1c
- Major heart conditions or surgeries within 3 months before first dose
- Planned heart surgery or revascularization during the study
- Advanced heart failure (NYHA Class III-IV)
- Pregnant or breastfeeding women
- Poorly controlled high blood pressure
- Elevated creatine kinase levels unexplained by exercise
- Recent LDL apheresis or plasma exchange within 2 months
- Positive tests for HIV, syphilis, hepatitis C, or high hepatitis B viral load
- History of drug or alcohol abuse within 6 months
- Allergies to protein biologics or major drug allergies
- Participation in another clinical trial within 30 days or less than 5 drug half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks randomized treatment plus 36 weeks open-label treatment
Participants receive either HST101 or placebo by subcutaneous injection every 4 weeks during the randomized, double-blind treatment period, followed by an open-label period where all participants receive HST101.
Visits every 4 weeks for 48 weeks
Duration - 4 weeks
Participants are monitored for safety and any adverse events after completing the treatment periods.
1 visit (in-person)
Trial Site Locations
Total: 18 locations
1
Beijing Anzhen Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Beijing Luhe Hospital, Capital Medical Univeristy
Beijing, Beijing Municipality, China
Actively Recruiting
3
Beijing Tsinghua Changgeng Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
4
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China
Actively Recruiting
5
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
6
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Actively Recruiting
7
Daqingshi People's Hospital
Daqing, Heilingjiang, China
Actively Recruiting
8
The 2nd Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
9
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
10
Nanchang People's Hospital
Nanchang, Jiangxi, China
Actively Recruiting
11
Binzhou Medical University Hospital
Binzhou, Shandong, China
Actively Recruiting
12
Heze Municipal Hospital
Heze, Shandong, China
Actively Recruiting
13
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
14
Zibo Municipal Hospital
Zibo, Shandong, China
Actively Recruiting
15
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
16
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
17
The First Affiliated Hospital of Wenzhou Medical Univesity
Wenzhou, Zhejiang, China
Actively Recruiting
18
Peking University First Hospital
Beijing, China, 100034
Not Yet Recruiting
Research Team
Y
Yong Huo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here