HypercholesterolemiaPhase 3NCT06568471
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
A Phase 3 study testing Lerodalcibep in people with Hypercholesterolemia and Dyslipidemias, run by Hasten Biopharmaceutical Co., Ltd. at 18 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemias, Primary Hypercholesterolemia
- What is being tested?
- Lerodalcibep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 18 sitesChina
- Study dates
- 16 Nov 2024to May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written and signed informed consent form prior to any study-specific procedure;
- Male or female participants ≥18 years of age at the screening visit;
- Body weight ≥ 40 kg and body mass index (BMI) ≥18 and ≤35 kg/m2;
- On a stable diet and lipid-lowering oral drugs (such as statins, ezetimibe or Hybutimibe, omega-3 compounds, fenofibrate, nicotinic acid, etc.) for at least 4 weeks prior to the first drug administration
- LDL-C≥1.8 mmol/L (70 mg/dL) and TG≤4.52 mmol/L (400 mg/dL) at screening for ASCVD patients or those at very (ultra)-high risk for ASCVD, including patients with HeFH; LDL-C ≥ 2.6 mmol/L (100 mg/dL) and TG ≤ 4.52 mmol/L (400 mg/dL) at screening for patients at high-risk for ASCVD including patients with HeFH;
- Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥6 weeks after the last dose; for those on 300 mg or 420 mg Q4W, the washout period is ≥10 weeks following last dose;
- Female of childbearing potential must have a negative pregnancy test at the last screening visit and consent to use highly effective contraceptives during the trial and 3 months after the last dose of investigational drug.
Who cannot join
- Documented history of homozygous familial hypercholesterolemia (HoFH);
- Estimated glomerular filtration rate (eGFR)<30 mL/min/1.73m2;
- Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST >2.5 × ULN at screening;
- Poorly controlled thyroid disorder including hypothyroidism or hyperthyroidism;
- Poorly controlled Type 1 or Type 2 diabetes mellitus defined as fasting blood glucose ≥11.0 mmol/L (200 mg/dL) and glycosylated hemoglobin (HbA1c) ≥ 9%;
- Serious arrhythmia, MI, unstable angina pectoris, PCI, CABG, implantable cardioverter defibrillator, aortic valve surgery or stroke within 3 months prior to the first dose;
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- Planned cardiac surgery or revascularization during the study period;
- New York Heart Association (NYHA) Class III-IV heart failure;
- Pregnant or lactating women;
- Poorly controlled hypertension (SBP≥160 mmHg or DBP≥100 mmHg in a sitting position)
- Unexplained creatine kinase (CK) > 5 x ULN (retested once is needed if suspected to be related to excessive exercise or abnormal activity);
- LDL apheresis or plasma exchange within 2 months prior to the first dose;
- HIV, Treponema pallidum, or HCV antibody test positive, or HBV-DNA >ULN at screening;
- History of prescription drug abuse, illicit drug use or alcohol abuse within 6 months prior to screening;
- History of any major drug allergy, including allergy to protein biologics;
- Participate another clinical trial within 30 days or less than 5 half-lifes (drug) before screening, whichever is longer
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Beijing Anzhen Hospital of Capital Medical University
Beijing, Beijing Municipality
Yujie Zhou, +86-10-64412431, azzyj12@163.com
- Recruiting
Beijing Luhe Hospital, Capital Medical Univeristy
Beijing, Beijing Municipality
Guangyao Zhai, +86-10-69543901, Drzhaiguangyao@163.com
- Recruiting
Beijing Tsinghua Changgeng Hospital
Beijing, Beijing Municipality
Ping Zhang, +86-10-56112345, zhpdoc@126.com
- Recruiting
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality
Naqiong Wu, +86-10-88398866, fuwainaqiongwu@163.com
- Not yet recruiting
Peking University First Hospital
Beijing, 100034
Yong Huo, +86 13901333060, huoyong@263.net.cn
- Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong
Huipu Xu, +86-543-3256969, xuhuipu@126.com
- Recruiting
The 2nd Xiangya Hospital of Central South University
Changsha, Hunan
Daoquan Peng, +86-731-85295888, pengdq@hotmail.com
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Weihong Jiang, +86-731-88618576, jwhxy3@126.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Ye Zhu, +86-28-85422114, zhuye1974@163.com
- Recruiting
Daqingshi People's Hospital
Daqing, Heilingjiang
Shu Zhang, +86-459-6612000, zhangshu7801182@163.com
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Ning Tan, +86-20-83827812, tanning100@126.com
- Recruiting
Heze Municipal Hospital
Heze, Shandong
Beijian Chen, +86-530-5613239, cbj9603@163.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Cheng Zhang, +86-531-82166666, zhangc@sdu.edu.cn
- Recruiting
Nanchang People's Hospital
Nanchang, Jiangxi
Zhaohui Pei, +86-791-86612623, Leak123@126.com
- Recruiting
Shijiazhuang People's Hospital
Shijiazhuang, Hebei
Jianping Zhang, +86-311-69089999, zjpzjp2013@sina.com
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality
Zhuhua Yao, +86-22-87729595, yzhpci@yahoo.com.cn
- Recruiting
The First Affiliated Hospital of Wenzhou Medical Univesity
Wenzhou, Zhejiang
Zhouqing Huang, +86-577-55578061, susiehzq@126.com
- Recruiting
Zibo Municipal Hospital
Zibo, Shandong
Guanzhong Zheng, +86-533-7162009, m17660292598@163.com
About this study
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
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.
Read the 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 2:1 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.
- Conditions
- Hypercholesterolemia, Dyslipidemias, Primary Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia, Hyperlipidemia; Mixed, Metabolic Disease
- Being tested
- Lerodalcibep, matching placebo
- Keywords
- PCSK9 inhibitor, Lerodalcibep, LDL-C
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias, Hyperlipoproteinemia Type II, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LerodalcibepDrug
Also called HST101, LIB003
PCSK9 inhibitor
matching placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| HST101(Lerodalcibep) | Experimental | 300 mg subcutaneously Q4W Receives: Drug: Lerodalcibep |
| Placebo | Placebo comparator | subcutaneously Q4W Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C change compared to Placebo
Percent change in LDL-C level from baseline (calculated by Friedewald formula) compared to Placebo
Measured: 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
Measured: 12 weeks
Secondary outcomes (5)
LDL-C change over time
Absolute and percent change in LDL-C level from baseline at Weeks 4, 8, 10, and 12
Measured: 12 weeks
Free PCSK9 change
Absolute and Percent change in serum free PCSK9 level from baseline at Weeks 4,8 and 12
Measured: 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
Measured: 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)
Measured: 12 weeks
Incidence of treatment-emergent adverse events
Evaluation of adverse events, clinical lab tests, 12-lead ECG, vital signs, injection site reactions (ISRs)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start16 Nov 2024
- Primary completionFeb 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will be in-parallel randomized in a 2:1 ratio to HST101 or Placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasten Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong Huo, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568471
- Sponsor's protocol ID
- HST101-301
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06568471
- Acronym / sponsor ID
- HST101-301
- Conditions
- Hypercholesterolemia, Dyslipidemias, Primary Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia, Hyperlipidemia; Mixed, Metabolic Disease
- Keywords
- PCSK9 inhibitor, Lerodalcibep, LDL-C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hasten Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 2:1 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will be in-parallel randomized in a 2:1 ratio to HST101 or Placebo
| Arm | Type | Receives |
|---|---|---|
| HST101(Lerodalcibep) | Experimental | Drug: Lerodalcibep300 mg subcutaneously Q4W |
| Placebo | Placebo comparator | Drug: matching placebosubcutaneously Q4W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of written and signed informed consent form prior to any study-specific procedure;
- Male or female participants ≥18 years of age at the screening visit;
- Body weight ≥ 40 kg and body mass index (BMI) ≥18 and ≤35 kg/m2;
- On a stable diet and lipid-lowering oral drugs (such as statins, ezetimibe or Hybutimibe, omega-3 compounds, fenofibrate, nicotinic acid, etc.) for at least 4 weeks prior to the first drug administration
- LDL-C≥1.8 mmol/L (70 mg/dL) and TG≤4.52 mmol/L (400 mg/dL) at screening for ASCVD patients or those at very (ultra)-high risk for ASCVD, including patients with HeFH; LDL-C ≥ 2.6 mmol/L (100 mg/dL) and TG ≤ 4.52 mmol/L (400 mg/dL) at screening for patients at high-risk for ASCVD including patients with HeFH;
Key exclusion criteria (16 listed)
- Documented history of homozygous familial hypercholesterolemia (HoFH);
- Estimated glomerular filtration rate (eGFR)<30 mL/min/1.73m2;
- Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST >2.5 × ULN at screening;
- Poorly controlled thyroid disorder including hypothyroidism or hyperthyroidism;
- Poorly controlled Type 1 or Type 2 diabetes mellitus defined as fasting blood glucose ≥11.0 mmol/L (200 mg/dL) and glycosylated hemoglobin (HbA1c) ≥ 9%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LerodalcibepAlso: HST101, LIB003PCSK9 inhibitor | Drug | HST101(Lerodalcibep) |
| matching placeboplacebo | Drug | Placebo |
Primary outcome
LDL-C change compared to Placebo
Time frame: 12 weeks
Percent change in LDL-C level from baseline (calculated by Friedewald formula) compared to Placebo
Mean LDL-C change at Weeks 10 and 12 compared to Placebo
Time frame: 12 weeks
Percent change in mean LDL-C level from baseline (calculated by Friedewald formula) compared to placebo at Weeks 10 and 12
5 secondary outcomes
LDL-C change over time
Time frame: 12 weeks
Free PCSK9 change
Time frame: 12 weeks
Other Lipid parameters change
Time frame: 12 weeks
Percentage of patients achieving LDL-C goals recommended by 2023 Chinese guideline
Time frame: 12 weeks
Incidence of treatment-emergent adverse events
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Huo principal investigator
Peking University First Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lerodalcibep in people with Hypercholesterolemia and Dyslipidemias, run by Hasten Biopharmaceutical Co., Ltd. at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Huo (+86 13901333060, huoyong@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C change compared to Placebo (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.