Hyperlipoproteinemia (a)Phase 2NCT07914660
Study of YKYY032 Injection in Adults With Hyperlipoproteinemia (a)
A Phase 2 study testing YKYY032 group in people with Hyperlipoproteinemia (a), run by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Phase II clinical trial to evaluate the efficacy and safety of YKYY032 injection in adults with hyperlipoproteinemia (a) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipoproteinemia (a)
- What is being tested?
- YKYY032 group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2026to 31 May 2029
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Before starting any research on a specific activity/program, a written informed consent must be provided;
- For both males and females, the age at signing the Informed Consent Form (ICF) should be between 18 and 80 years;
- The body mass index should be within the range of 18.5 - 40 kg/㎡ (including the boundary values);
- During the pre-screening period (if any) and the screening period, the fasting Lp(a) measured in the central laboratory of the trial participants should be ≥ 150 nmol/L;
- According to one of the following criteria, the participants are clinically diagnosed with ASCVD, including but not limited to:
- Having a history of coronary artery revascularization through percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
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- Diagnosed with coronary artery disease, with or without a previous myocardial infarction;
- Diagnosed with atherosclerotic cerebrovascular disease;
- Diagnosed with peripheral artery disease; or without a clinical history of ASCVD, but meeting the definition of high-risk individuals for ASCVD in the overall risk assessment flowchart for ASCVD in Chinese lipid management guidelines (2023) (see Appendix 16.1 for the overall risk assessment flowchart for ASCVD in Chinese adults);
- For the trial participants who receive the following drug treatments, their treatment plans must be stable for at least 4 weeks before signing the screening ICF, and are expected to remain stable until the end of the follow-up period after the last administration of the trial drug:
- Lipid-lowering drugs (statins, ezetimibe, PCSK9 inhibitors, niacin, fibrates, fish oil or other products containing ω-3 fatty acids, including over-the-counter drugs [OTC]);
- Testosterone, estrogen, anti-estrogen, progesterone, progestin, selective estrogen receptor modulators and growth hormone.
- Female trial participants are not pregnant or breastfeeding; fertile female and male trial participants must have an acceptable contraceptive method from the time of signing the ICF until 12 months after the last administration of the trial drug (see Appendix 16.2 for the requirements for trial participants' contraception); males are not allowed to donate sperm, and females are not allowed to donate eggs;
- They are willing to follow the research procedures stipulated in this protocol (including follow-up) and are willing to cooperate fully with the researchers.
Who cannot join
- Clinical evidence of active liver disease or liver dysfunction in the past or currently exists, defined as AST or ALT ≥ 2 times the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5 times the ULN at the screening period (except for participants diagnosed with Gilbert syndrome);
- Estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) creatinine clearance formula is < 60 mL/min/1.73 ㎡ during the screening period;
- Any recent major cardiovascular event (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, unstable angina pectoris, coronary or peripheral artery revascularization, major cardiac surgery, stroke or transient ischemic attack, acute limb ischemia) or non-cardiac major surgery within 6 months before randomization;
- Any planned cardiac surgery, PCI or carotid artery stenting procedure during the study period, or planned non-cardiac major surgery;
- Moderate to severe heart failure (NYHA functional class III or IV at the screening period) or previously known left ventricular ejection fraction < 50%;
- Uncontrolled hypertension (systolic blood pressure [SBP] ≥ 160 mmHg or diastolic blood pressure [DBP] ≥ 100 mmHg);
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- Presence of uncontrolled arrhythmia within 3 months before randomization, defined as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or drug-uncontrolled supraventricular tachycardia;
- Any malignancy within 5 years before randomization (successfully treated non-melanoma skin cancer, cervical carcinoma in situ, breast duct carcinoma, or stage 1 prostate cancer excluded);
- Any hereditary or other bleeding disorders;
- Fasting triglycerides ≥ 500 mg/dL (5.65 mmol/L) at the screening period;
- Fasting LDL-C ≥ 4.9 mmol/L (190 mg/dL) at the screening period;
- Presence of type 1 diabetes or poorly controlled type 2 diabetes (defined as requiring hospitalization for ketoacidosis or hyperosmolar hyperglycemic state, or glycated hemoglobin [HbA1c] ≥ 8.5% at the screening period, or hospitalization due to poor glycemic control) within 3 months before randomization;
- Uncontrolled hyperthyroidism or hypothyroidism (stable treatment with abnormal thyroid hormone or unrelieved clinical symptoms);
- Any active infection or major hematological, renal, metabolic, gastrointestinal or endocrine dysfunction requiring systemic antiviral or antimicrobial treatment by the investigator's judgment before randomization;
- Evidence of acute or chronic hepatitis B or hepatitis C at the screening period (positive for hepatitis B surface antigen [HBsAg]; or positive for hepatitis C antibody [HCV-Ab]), or human immunodeficiency virus (HIV) infection (positive for HIV antibody), or active syphilis infection (positive for Treponema pallidum antibody);
- Any ASO, small interfering RNA (siRNA) treatment (such as Inclisiran sodium injection) or any experimental treatment targeting Lp(a) within 12 months before randomization;
- Stable use of immunosuppressants, or stable use of corticosteroids (excluding topical/inhaled use) within 3 months before randomization (continuous use >14 days is considered stable use); or regular systemic corticosteroid use within 4 weeks before the first dose; or expected need for prednisone >20 mg/day or equivalent;
- Currently receiving, or having received lipoprotein apheresis within 3 months before randomization, or planning to receive lipoprotein apheresis during the study;
- Have homozygous familial hypercholesterolemia (HoFH) or have received lomitapide within 12 months prior to randomization;
- Are known to be allergic to any component of YKYY032 injection, or have a history or current severe allergic reaction;
- Have participated in or plan to participate in a drug clinical trial within 3 months prior to screening, or within the trial period (excluding non-interventional studies and those who only signed the ICF but did not receive study intervention);
- Have had or currently have drug abuse or alcoholism (for men, an average weekly alcohol intake of more than 14 units, for women, more than 7 units [1 unit = 360 mL beer; or 150 mL wine; or 45 mL distilled spirits]);
- Have received any known herbal medicine (including but not limited to: hawthorn, salvia miltiorrhiza), vitamin (including but not limited to: niacin), or supplement (including but not limited to: red yeast rice, omega-3 fatty acids) within 30 days prior to randomization, except for those who have been using lipid-lowering drugs stably for 4 weeks prior to screening (see item 6 of the inclusion criteria);
- Have had or currently have any underlying disease or mental condition that the investigator considers may affect the safety of the study participants during the study, or interfere with the participation or completion of the study, or affect the interpretation of data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jianping Li, +86-10-64009673, 13521531013@163.com
About this study
Official title: A Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial of YKYY032 Injection in Adults With Hyperlipoproteinemia (a)
Phase II clinical trial to evaluate the efficacy and safety of YKYY032 injection in adults with hyperlipoproteinemia (a)
Read the detailed description
This is a randomized, double-blind, parallel, placebo-controlled Phase II clinical study, aiming to evaluate the efficacy and safety of YKYY032 injection in adult patients with hyperlipoproteinemia (a).
- Conditions
- Hyperlipoproteinemia (a)
- Being tested
- YKYY032 group, YKYY032 Placebo group
- Medical subject headings
- Hyperlipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKYY032 groupDrug
Drug: YKYY032 Injection Subcutaneous administration of YKYY032 on Day 1 and Day 180 (2 doses, approximately 6 months apart)
YKYY032 Placebo groupOther
Drug: YKYY032 Placebo Subcutaneous administration of matching placebo on Day 1 and Day 180 (2 doses, approximately 6 months apart)
| Study group | Role | What they receive |
|---|---|---|
| YKYY032 group | Active comparator | Drug: YKYY032 Injection Subcutaneous administration of YKYY032 on Day 1 and Day 180 (2 doses, approximately 6 months apart) Receives: Drug: YKYY032 group |
| YKYY032 Placebo group | Placebo comparator | Drug: YKYY032 Placebo Subcutaneous administration of matching placebo on Day 1 and Day 180 (2 doses, approximately 6 months apart) Receives: Other: YKYY032 Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change from baseline in time average Lp(a) over Days 60-180.
Measured: Baseline, Days 60 - 180
Secondary outcomes (9)
The proportion of participants achieving Lp(a) < 125 nmol/L and < 75 nmol/L at Days 60, 180, 240, 360 and 540.
Measured: Days 60, 180, 240, 360 and 540
The percentage change of Lp(a) from the baseline at Days 60, 180, 240, 360 and 540.
Measured: Baseline, Days 60, 180, 240, 360 and 540
The absolute value of the change of Lp(a) from the baseline at Days 60, 180, 240, 360 and 540.
Measured: Baseline, Days 60, 180, 240, 360 and 540
The percentage change of LDL-C from the baseline at Days 60, 180, 240, 360 and 540.
Measured: Baseline, Days 60, 180, 240, 360 and 540
The percentage change of ApoB from the baseline at Days 60, 180, 240, 360 and 540.
Measured: Baseline, Days 60, 180, 240, 360 and 540
The percentage change from baseline in other lipid parameters, including total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C) at Days 60, 180, 240, 360 and 540.
Measured: Baseline, Days 60, 180, 240, 360 and 540
Percent change in High-sensitivity C-reactive Protein (hsCRP) from baseline.
Measured: Baseline, Days 60, 180, 240, 360 and 540
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of YKYY032
Measured: Day 1: pre-dose, post-dose 1-3 hours, 3-6 hours, 7-9 hours, 22-26 hours (Day 2), 46-50 hours (Day 3); Day 180: 1-3 hours, 3-6 hours, 7-9 hours, 22-26 hours (Day 181), 46-50 hours (Day 182) post-dose
The incidence and severity of adverse events (TEAE); Vital signs, physical examination results, laboratory test results, 12-lead electrocardiogram (ECG), etc.
Measured: During the clinical trial period, up to Day 540.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperlipoproteinemia (a)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914660
- Sponsor's protocol ID
- CLSP-YKYY032-Z02
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial of YKYY032 Injection in Adults With Hyperlipoproteinemia (a)
- ClinicalTrials.gov ID
- NCT07914660
- Acronym / sponsor ID
- CLSP-YKYY032-Z02
- Conditions
- Hyperlipoproteinemia (a)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 3 Nov 2026 (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.
Phase II clinical trial to evaluate the efficacy and safety of YKYY032 injection in adults with hyperlipoproteinemia (a)
Detailed description
This is a randomized, double-blind, parallel, placebo-controlled Phase II clinical study, aiming to evaluate the efficacy and safety of YKYY032 injection in adult patients with hyperlipoproteinemia (a).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YKYY032 group | Active comparator | Drug: YKYY032 groupDrug: YKYY032 Injection Subcutaneous administration of YKYY032 on Day 1 and Day 180 (2 doses, approximately 6 months apart) |
| YKYY032 Placebo group | Placebo comparator | Other: YKYY032 Placebo groupDrug: YKYY032 Placebo Subcutaneous administration of matching placebo on Day 1 and Day 180 (2 doses, approximately 6 months apart) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Before starting any research on a specific activity/program, a written informed consent must be provided;
- For both males and females, the age at signing the Informed Consent Form (ICF) should be between 18 and 80 years;
- The body mass index should be within the range of 18.5 - 40 kg/㎡ (including the boundary values);
- During the pre-screening period (if any) and the screening period, the fasting Lp(a) measured in the central laboratory of the trial participants should be ≥ 150 nmol/L;
- According to one of the following criteria, the participants are clinically diagnosed with ASCVD, including but not limited to:
Key exclusion criteria (24 listed)
- Clinical evidence of active liver disease or liver dysfunction in the past or currently exists, defined as AST or ALT ≥ 2 times the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5 times the ULN at the screening period (except for participants diagnosed with Gilbert syndrome);
- Estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) creatinine clearance formula is < 60 mL/min/1.73 ㎡ during the screening period;
- Any recent major cardiovascular event (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, unstable angina pectoris, coronary or peripheral artery revascularization, major cardiac surgery, stroke or transient ischemic attack, acute limb ischemia) or non-cardiac major surgery within 6 months before randomization;
- Any planned cardiac surgery, PCI or carotid artery stenting procedure during the study period, or planned non-cardiac major surgery;
- Moderate to severe heart failure (NYHA functional class III or IV at the screening period) or previously known left ventricular ejection fraction < 50%;
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 |
|---|---|---|
| YKYY032 groupDrug: YKYY032 Injection Subcutaneous administration of YKYY032 on Day 1 and Day 180 (2 doses, approximately 6 months apart) | Drug | YKYY032 group |
| YKYY032 Placebo groupDrug: YKYY032 Placebo Subcutaneous administration of matching placebo on Day 1 and Day 180 (2 doses, approximately 6 months apart) | Other | YKYY032 Placebo group |
Primary outcome
The percentage change from baseline in time average Lp(a) over Days 60-180.
Time frame: Baseline, Days 60 - 180
9 secondary outcomes
The proportion of participants achieving Lp(a) < 125 nmol/L and < 75 nmol/L at Days 60, 180, 240, 360 and 540.
Time frame: Days 60, 180, 240, 360 and 540
The percentage change of Lp(a) from the baseline at Days 60, 180, 240, 360 and 540.
Time frame: Baseline, Days 60, 180, 240, 360 and 540
The absolute value of the change of Lp(a) from the baseline at Days 60, 180, 240, 360 and 540.
Time frame: Baseline, Days 60, 180, 240, 360 and 540
The percentage change of LDL-C from the baseline at Days 60, 180, 240, 360 and 540.
Time frame: Baseline, Days 60, 180, 240, 360 and 540
The percentage change of ApoB from the baseline at Days 60, 180, 240, 360 and 540.
Time frame: Baseline, Days 60, 180, 240, 360 and 540
The percentage change from baseline in other lipid parameters, including total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and non-high-density lipoprotein cholesterol (non-HDL-C) at Days 60, 180, 240, 360 and 540.
Time frame: Baseline, Days 60, 180, 240, 360 and 540
Percent change in High-sensitivity C-reactive Protein (hsCRP) from baseline.
Time frame: Baseline, Days 60, 180, 240, 360 and 540
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of YKYY032
Time frame: Day 1: pre-dose, post-dose 1-3 hours, 3-6 hours, 7-9 hours, 22-26 hours (Day 2), 46-50 hours (Day 3); Day 180: 1-3 hours, 3-6 hours, 7-9 hours, 22-26 hours (Day 181), 46-50 hours (Day 182) post-dose
The incidence and severity of adverse events (TEAE); Vital signs, physical examination results, laboratory test results, 12-lead electrocardiogram (ECG), etc.
Time frame: During the clinical trial period, up to Day 540.
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 3 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YKYY032 group in people with Hyperlipoproteinemia (a), run by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. at 1 site 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 14 inclusion and 24 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 Yuting Zhou (+86 18606417018, zhouyuting@bjykkc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change from baseline in time average Lp(a) over Days 60-180. (time frame: Baseline, Days 60 - 180). 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 3 Nov 2026.