HypercholesterolemiaPhase 2NCT04358432
A Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia
A Phase 2 study testing AK102 and Statins and/or Ezetimibe in people with Hypercholesterolemia, run by Akeso at 2 sites in China.
Trial summary
This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- AK102 and Statins and/or Ezetimibe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 2 sitesChina
- Study dates
- 13 May 2020to 25 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Voluntarily sign the informed consent form (ICF), and be able to comply with the treatment plan, visit, laboratory examination and other requirements specified in the study;
- Age ≥ 18, male or female;
- According to the guidelines for the prevention and treatment of dyslipidemia in Chinese adults (revised in 2016), subjects assessed as very high risk or high risk of cardiovascular disease;
- Subjects received stable and optimal dose of statins for at least 4 weeks before randomization, either in combination with or without ezetimibe;
- The blood lipid level of the patients with stable 4-week basic lipid-lowering drug treatment met one of the following conditions by the central laboratory test: LDL-C level in very high risk subjects > 1.8 mmol / L (70 mg / dl) or LDL-C level of high-risk subjects > 2.6 mmol / L (100 mg / dl)
- TG ≤ 4.5 mmol / L (400 mg / dl) measured by central laboratory at screening；
Who cannot join
- Has received cholesterol ester transfer protein (CETP) inhibitor within12 months prior to randomization;
- Has received PCSK9 inhibitors or are known to be allergic to PCSK9 inhibitors or their components;
- Has received other investigational drugs within 4 weeks or within 5 half lives (whichever was longer) prior to screening.
- Has previously received biological agent treatment, organ transplantation or gene therapy;
- Abnormal laboratories prior to the first study drug administration: ALT or AST> 3 × ULN; Creatine kinase > 5 × ULN; eGFR <= 30 ml/min/1.73m2 by Cockcroft Gault method;
- Uncontrolled hypothyroidism or hyperthyroidism defined as TSH < 1.0 ×LLN or > 1.5 × ULN, respectively;
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- Myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI), coronary bypass grafting (CABG), stroke, severe deep vein thrombosis or pulmonary embolism, or severe arrhythmia occurred within three months prior to randomization ;
- Grade III or IV according to NYHA assessment;
- Planned to have heart-related surgery within 3 months after randomization;
- Type 1 diabetes or poorly controlled type 2 diabetes [HbA1c > 8.5% within 1 month];
- Subjects with hypertension that could not be controlled by drugs;
- Known concomitant diseases that may lead to secondary hyperlipidemia, including nephrotic syndrome, cholestatic liver failure, etc;
- Positive HBsAg or HCV antibody;
- Known history of primary immunodeficiency virus infection or positive human immunodeficiency virus (HIV) test;
- History of drug or alcohol abuse prior to screening;
- Has taken the following drugs within 6 weeks prior to screening: red koji rice > 200 mg/day; niacin > 1000 mg/day; omega-3 fatty acids; steroids or prescription lipid regulating drugs ; cholesterol lowering drugs, health care products, Chinese patent medicines or other food additives other than statins and ezetimibe;
- Has taken the following drugs within 3 months prior to screening: systemic cyclosporine, systemic steroids, vitamin A derivatives and retinol derivatives for the treatment of skin diseases (such as retinoic acid).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhong Shan Hosipital Fu Dan University
Shanghai, 200032
Affiliated hospital of Guangdong medical university
Zhanjiang, 524000
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Phase II Study of AK102 in the Treatment of Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease
This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .
The primary objective of this study is to evaluate the efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .
- Conditions
- Hypercholesterolemia
- Being tested
- AK102, Placebos, Statins and/or Ezetimibe
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK102Drug
Administered by subcutaneous injection
PlacebosDrug
Administered by subcutaneous injection
Statins and/or EzetimibeDrug
Lipid-lowering therapies
| Study group | Role | What they receive |
|---|---|---|
| AK102 450 mg | Experimental | Participants received AK102 450 mg subcutaneous injection once every 4 weeks (Q4W) for 12 weeks Receives: Drug: AK102; Drug: Statins and/or Ezetimibe |
| AK102 300 mg | Experimental | Participants received AK102 300 mg subcutaneous injection once every 4 weeks (Q4W) for 12 weeks Receives: Drug: AK102; Drug: Statins and/or Ezetimibe |
| AK102 150 mg | Experimental | Participants received AK102 150 mg subcutaneous injection once every 2 weeks (Q2W) for 12 weeks Receives: Drug: AK102; Drug: Statins and/or Ezetimibe |
| AK102 75 mg | Experimental | Participants received AK102 75 mg subcutaneous injection once every 2 weeks (Q2W) for 12 weeks Receives: Drug: AK102; Drug: Statins and/or Ezetimibe |
| Placebo Q4W | Placebo comparator | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks Receives: Drug: Placebos; Drug: Statins and/or Ezetimibe |
| Placebo Q2W | Placebo comparator | Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks Receives: Drug: Placebos; Drug: Statins and/or Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 12
Measured: At baseline and week 12
Secondary outcomes (12)
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Measured: From baseline through 12 weeks
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Measured: From baseline through 12 weeks
Percent change from baseline in non High-density lipoprotein (non-HDL) cholesterol
Measured: From baseline through 12 weeks
Percent change from baseline in serum Triglyceride (TG) cholesterol
Measured: From baseline through 12 weeks
Percent change from baseline in Apolipoprotein B (Apo B)
Measured: From baseline through 12 weeks
Percent change from baseline in Apolipoprotein A-I (ApoA-I)
Measured: From baseline through 12 weeks
Percent change from baseline in Lipoprotein(a) [Lp-(a)]
Measured: From baseline through 12 weeks
Percent change from baseline in Total Cholesterol(TC)
Measured: From baseline through 12 weeks
Incidence of treatment-emergent adverse events
Measured: From baseline through 12 weeks
Serum concentrations of AK102
Measured: From baseline through 12 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies.
Measured: From baseline through 12 weeks
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9)
Measured: From baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start13 May 2020
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
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.
- More trials run by AkesoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AD Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, MD, Principal investigator, Zhong Shan Hospital Fu Dan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358432
- Sponsor's protocol ID
- AK102-203
- Status last verified
- Mar 2023
- First submitted
- 21 Apr 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multicenter Phase II Study of AK102 in the Treatment of Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04358432
- Acronym / sponsor ID
- AK102-203
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- AD Pharmaceuticals Co., Ltd.
- Study start
- 13 May 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 24 Apr 2020 (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 is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .
The primary objective of this study is to evaluate the efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AK102 450 mg | Experimental | Drug: AK102, Drug: Statins and/or EzetimibeParticipants received AK102 450 mg subcutaneous injection once every 4 weeks (Q4W) for 12 weeks |
| AK102 300 mg | Experimental | Drug: AK102, Drug: Statins and/or EzetimibeParticipants received AK102 300 mg subcutaneous injection once every 4 weeks (Q4W) for 12 weeks |
| AK102 150 mg | Experimental | Drug: AK102, Drug: Statins and/or EzetimibeParticipants received AK102 150 mg subcutaneous injection once every 2 weeks (Q2W) for 12 weeks |
| AK102 75 mg | Experimental | Drug: AK102, Drug: Statins and/or EzetimibeParticipants received AK102 75 mg subcutaneous injection once every 2 weeks (Q2W) for 12 weeks |
| Placebo Q4W | Placebo comparator | Drug: Placebos, Drug: Statins and/or EzetimibeParticipants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks |
| Placebo Q2W | Placebo comparator | Drug: Placebos, Drug: Statins and/or EzetimibeParticipants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily sign the informed consent form (ICF), and be able to comply with the treatment plan, visit, laboratory examination and other requirements specified in the study;
- Age ≥ 18, male or female;
- According to the guidelines for the prevention and treatment of dyslipidemia in Chinese adults (revised in 2016), subjects assessed as very high risk or high risk of cardiovascular disease;
- Subjects received stable and optimal dose of statins for at least 4 weeks before randomization, either in combination with or without ezetimibe;
- The blood lipid level of the patients with stable 4-week basic lipid-lowering drug treatment met one of the following conditions by the central laboratory test: LDL-C level in very high risk subjects > 1.8 mmol / L (70 mg / dl) or LDL-C level of high-risk subjects > 2.6 mmol / L (100 mg / dl)
Key exclusion criteria (17 listed)
- Has received cholesterol ester transfer protein (CETP) inhibitor within12 months prior to randomization;
- Has received PCSK9 inhibitors or are known to be allergic to PCSK9 inhibitors or their components;
- Has received other investigational drugs within 4 weeks or within 5 half lives (whichever was longer) prior to screening.
- Has previously received biological agent treatment, organ transplantation or gene therapy;
- Abnormal laboratories prior to the first study drug administration: ALT or AST> 3 × ULN; Creatine kinase > 5 × ULN; eGFR <= 30 ml/min/1.73m2 by Cockcroft Gault method;
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 |
|---|---|---|
| AK102Administered by subcutaneous injection | Drug | AK102 150 mg, AK102 300 mg, AK102 450 mg, AK102 75 mg |
| PlacebosAdministered by subcutaneous injection | Drug | Placebo Q2W, Placebo Q4W |
| Statins and/or EzetimibeLipid-lowering therapies | Drug | AK102 150 mg, AK102 300 mg, AK102 450 mg, AK102 75 mg, Placebo Q2W, Placebo Q4W |
Primary outcome
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 12
Time frame: At baseline and week 12
12 secondary outcomes
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: From baseline through 12 weeks
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time frame: From baseline through 12 weeks
Percent change from baseline in non High-density lipoprotein (non-HDL) cholesterol
Time frame: From baseline through 12 weeks
Percent change from baseline in serum Triglyceride (TG) cholesterol
Time frame: From baseline through 12 weeks
Percent change from baseline in Apolipoprotein B (Apo B)
Time frame: From baseline through 12 weeks
Percent change from baseline in Apolipoprotein A-I (ApoA-I)
Time frame: From baseline through 12 weeks
Percent change from baseline in Lipoprotein(a) [Lp-(a)]
Time frame: From baseline through 12 weeks
Percent change from baseline in Total Cholesterol(TC)
Time frame: From baseline through 12 weeks
Incidence of treatment-emergent adverse events
Time frame: From baseline through 12 weeks
Serum concentrations of AK102
Time frame: From baseline through 12 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From baseline through 12 weeks
Change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9)
Time frame: From baseline through 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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. This study is not recruiting at the moment.
Junbo Ge, MD principal investigator
Zhong Shan Hospital Fu Dan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK102 and Statins and/or Ezetimibe in people with Hypercholesterolemia, run by Akeso at 2 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 12 (time frame: At baseline and week 12). 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 2 Mar 2023.