HyperlipidemiaNCT07712042
Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals
An observational study of Hyperlipidemia, run by Mei Gao at 1 site in China.
Trial summary
This is a prospective, observational cohort study. Patients will be assigned to either the Q2W or Q3W group based on the treating physician's clinical decision, not by randomization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Tafolecimab
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Dec 2028
- Phase
- Observational
- 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
Study population: Patients diagnosed with hyperlipidemia who have received moderate-intensity statin therapy for at least 4 weeks prior to enrollment, with or without cholesterol absorption inhibitors, and who have not achieved LDL-C targets according to the 2023 Chinese Lipid Management Guidelines based on their ASCVD risk stratification , or patients for whom clinicians anticipate that LDL-C targets will not be achieved with continued moderate-intensity statin therapy and who are planned to receive PCSK9 inhibitor treatment.
Who may be able to join
- 1) Age ≥18 years. 2) Diagnosed with hyperlipidemia and on a stable, regular dose of moderate-intensity statins for at least 4 weeks (specifically: Atorvastatin 10 mg/d, Rosuvastatin 5 mg/d, Fluvastatin 80 mg/d, Pitavastatin 2-4 mg/d, Pravastatin 40 mg/d, Simvastatin 20-40 mg/d, or Xuezhikang 1.2 g/d), with or without concurrent cholesterol absorption inhibitors.
- 3) Baseline LDL-C levels failing to reach the therapeutic target corresponding to the patient's ASCVD risk categorization (defined as follows):ASCVD Primary Prevention (Low Risk): LDL-C ≥ 3.4 mmol/L；ASCVD Primary Prevention (Moderate/High Risk): LDL-C ≥ 2.6 mmol/L；ASCVD Secondary Prevention (Very High Risk): LDL-C ≥ 1.8 mmol/L OR reduction from baseline ≥ 50%；ASCVD Secondary Prevention (Ultra-High Risk): LDL-C ≥ 1.4 mmol/L OR reduction from baseline ≥ 50% 4) Meets the standard clinical criteria for PCSK9 inhibitor initiation, OR the treating physician estimates that continuing current moderate-intensity statins cholesterol absorption inhibitor therapy will not achieve the target LDL-C levels, thereby requiring combination therapy with a PCSK9 inhibitor.
- 5) First-time user of tafolecimab (PCSK9 inhibitor-naïve). 6) Voluntarily participates in the study, provides written informed consent, and meets all follow-up compliance requirements.
- 7) Candidates must meet ALL of the above criteria to be eligible for enrollment in the study.
Who cannot join
- Marked liver function abnormalities at enrollment: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels 3 times or more above the upper limit of the normal reference range;
- Renal insufficiency at enrollment: serum creatinine levels above the upper limit of the normal reference range and/or endogenous creatinine clearance below the lower limit of the normal reference range;
- Severe heart failure: left ventricular ejection fraction ≤ 30%;
- Secondary dyslipidemia caused by factors such as thyroid dysfunction, nephrotic syndrome, or familial hyperlipidemia;
- Patients with connective tissue diseases, rheumatic or autoimmune diseases, rhabdomyolysis, hematologic disorders, or malignancies, combined with other types of intracranial diseases;
- Patients who have experienced an allergic reaction while taking oral statins or receiving Tafolecimab injections, as well as those with clear contraindications;
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- Patients with a history of major surgery or trauma, or who have developed severe acute or chronic infections during the follow-up period;
- Pregnant women;
- Patients with serious illnesses and a life expectancy of ≤3 months, such as those with malignant tumors;
- Other circumstances deemed unsuitable for participation by the investigators, including any medical or non-medical conditions that may increase the subject's risk, interfere with study assessments, or affect the subject's ability to complete the study.
- Participants meeting any of the above criteria must be excluded.
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
Qianfoshan Hospital
Ji'nan
Mei Gao, 0531-89269317, lixinyan0514@163.com
About this study
Official title: Efficacy and Safety of Tafolecimab With Different Dosing Intervals in Patients With Hyperlipidemia
This is a prospective, observational cohort study. Patients will be assigned to either the Q2W or Q3W group based on the treating physician's clinical decision, not by randomization. The aim is to evaluate the real-world effectiveness and safety of the two dosing regimens.This study aims to systematically evaluate the lipid-lowering efficacy and safety of two dosing regimens of Tafolecimab 150 mg-administered every two weeks (Q2W) versus every three weeks (Q3W)-over a 12-week period in patients with hyperlipidemia whose LDL-C remains above the target after 4 weeks of treatment with moderate-intensity statins with or without cholesterol absorption inhibitors. The primary efficacy endpoint is the percent change in LDL-C from baseline at week 12 of the initial treatment.
Read the detailed description
This is a prospective, observational cohort study conducted at the Department of Cardiology, Shandong First Medical University Affiliated First Hospital (Qianfoshan Hospital). The study aims to compare the efficacy and safety of Tafolecimab 150 mg administered every two weeks (Q2W) versus every three weeks (Q3W) in patients with hyperlipidemia who have not achieved their LDL-C targets after at least 4 weeks of moderate-intensity statin therapy, with or without cholesterol absorption inhibitors.
A total of 60 patients will be enrolled, with 30 patients allocated to each group based on clinical decision-making. Group A will receive Tafolecimab 150 mg subcutaneously every 2 weeks (Q2W), and Group B will receive Tafolecimab 150 mg subcutaneously every 3 weeks (Q3W). The treatment period is 12 weeks for both groups.
The primary efficacy outcome is the percent change in LDL-C from baseline at week 12. Secondary efficacy outcomes include the percent change in Lp(a) from baseline at week 12, LDL-C target achievement rates at each follow-up visit, and changes in TC, TG, HDL-C,, ApoB, and ApoA1 levels. Safety outcomes include the incidence of injection site reactions, liver transaminase elevation (ALT/AST ≥ 3×ULN), creatine kinase elevation (CK ≥ 5×ULN).
Follow-up visits are scheduled at week 2, 6, and 12 for Group A, and at week 3, 9, and 12 for Group B.
- Conditions
- Hyperlipidemia
- Being tested
- Tafolecimab
- Keywords
- Tafolecimab, PCSK9 inhibitor
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafolecimabDrug
Also called 托莱西单抗
150 mgSubcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Tafolecimab 150 mg Q2W | Participants receive Tafolecimab 150 mg subcutaneously every 2 weeks (Q2W) for 12 weeks. This group includes 30 patients with hyperlipidemia who have not achieved LDL-C targets after at least 4 weeks of moderate-intensity statin therapy with or without cholesterol absorption inhibitors. Receives: Drug: Tafolecimab | |
| Tafolecimab 150 mg Q3W | Participants receive Tafolecimab 150 mg subcutaneously every 3 weeks (Q3W) for 12 weeks. This group includes 30 patients with hyperlipidemia who have not achieved LDL-C targets after at least 4 weeks of moderate-intensity statin therapy with or without cholesterol absorption inhibitors. Receives: Drug: Tafolecimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in LDL-C at Week 12
Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 12. Calculated as: (Week 12 value - Baseline value) / Baseline value × 100%.
Measured: Baseline and Week 12
Secondary outcomes (4)
Percent Change in Lipoprotein(a) from Baseline at Week 12
Percent change in lipoprotein(a) [Lp(a)] from baseline to Week 12. Calculated as: (Week 12 value - Baseline value) / Baseline value × 100%.
Measured: Baseline and Week 12
LDL-C Target Achievement Rate
Proportion of participants achieving guideline-recommended LDL-C targets based on their ASCVD risk stratification at each designated visit (Week 2, 6, 12 for Q2W group; Week 3, 9, 12 for Q3W group).
Measured: At Week 2, 6, 12 (Q2W group) and Week 3, 9, 12 (Q3W group)
Changes in Other Lipid Parameters
Changes from baseline in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) at each designated visit.
Measured: Baseline and each designated visit (through Week 12)
Safety and Tolerability Profile
Incidence and severity of adverse events (AEs), including injection site reactions (erythema, swelling, induration, pain, pruritus), systemic reactions (flu-like symptoms, headache, fatigue), transaminase elevation ≥3× ULN, creatine kinase elevation ≥5× ULN, and cases of very low LDL-C (<0.5 mmol/L) with duration.
Measured: From first dose through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Gao, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712042
- Sponsor's protocol ID
- YXLL-KY-2026(001)
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 17 Jul 2026
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tafolecimab With Different Dosing Intervals in Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT07712042
- Acronym / sponsor ID
- YXLL-KY-2026(001)
- Conditions
- Hyperlipidemia
- Keywords
- Tafolecimab, PCSK9 inhibitor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mei GaoUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jul 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.
This is a prospective, observational cohort study. Patients will be assigned to either the Q2W or Q3W group based on the treating physician's clinical decision, not by randomization. The aim is to evaluate the real-world effectiveness and safety of the two dosing regimens.This study aims to systematically evaluate the lipid-lowering efficacy and safety of two dosing regimens of Tafolecimab 150 mg-administered every two weeks (Q2W) versus every three weeks (Q3W)-over a 12-week period in patients with hyperlipidemia whose LDL-C remains above the target after 4 weeks of treatment with moderate-intensity statins with or without cholesterol absorption inhibitors. The primary efficacy endpoint is the percent change in LDL-C from baseline at week 12 of the initial treatment.
Detailed description
This is a prospective, observational cohort study conducted at the Department of Cardiology, Shandong First Medical University Affiliated First Hospital (Qianfoshan Hospital). The study aims to compare the efficacy and safety of Tafolecimab 150 mg administered every two weeks (Q2W) versus every three weeks (Q3W) in patients with hyperlipidemia who have not achieved their LDL-C targets after at least 4 weeks of moderate-intensity statin therapy, with or without cholesterol absorption inhibitors.
A total of 60 patients will be enrolled, with 30 patients allocated to each group based on clinical decision-making. Group A will receive Tafolecimab 150 mg subcutaneously every 2 weeks (Q2W), and Group B will receive Tafolecimab 150 mg subcutaneously every 3 weeks (Q3W). The treatment period is 12 weeks for both groups.
The primary efficacy outcome is the percent change in LDL-C from baseline at week 12. Secondary efficacy outcomes include the percent change in Lp(a) from baseline at week 12, LDL-C target achievement rates at each follow-up visit, and changes in TC, TG, HDL-C,, ApoB, and ApoA1 levels. Safety outcomes include the incidence of injection site reactions, liver transaminase elevation (ALT/AST ≥ 3×ULN), creatine kinase elevation (CK ≥ 5×ULN).
Follow-up visits are scheduled at week 2, 6, and 12 for Group A, and at week 3, 9, and 12 for Group B.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tafolecimab 150 mg Q2W | – | Drug: TafolecimabParticipants receive Tafolecimab 150 mg subcutaneously every 2 weeks (Q2W) for 12 weeks. This group includes 30 patients with hyperlipidemia who have not achieved LDL-C targets after at least 4 weeks of moderate-intensity statin therapy with or without cholesterol absorption inhibitors. |
| Tafolecimab 150 mg Q3W | – | Drug: TafolecimabParticipants receive Tafolecimab 150 mg subcutaneously every 3 weeks (Q3W) for 12 weeks. This group includes 30 patients with hyperlipidemia who have not achieved LDL-C targets after at least 4 weeks of moderate-intensity statin therapy with or without cholesterol absorption inhibitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with hyperlipidemia who have received moderate-intensity statin therapy for at least 4 weeks prior to enrollment, with or without cholesterol absorption inhibitors, and who have not achieved LDL-C targets according to the 2023 Chinese Lipid Management Guidelines based on their ASCVD risk stratification , or patients for whom clinicians anticipate that LDL-C targets will not be achieved with continued moderate-intensity statin therapy and who are planned to receive PCSK9 inhibitor treatment.
Key inclusion criteria (4 listed)
- 1) Age ≥18 years. 2) Diagnosed with hyperlipidemia and on a stable, regular dose of moderate-intensity statins for at least 4 weeks (specifically: Atorvastatin 10 mg/d, Rosuvastatin 5 mg/d, Fluvastatin 80 mg/d, Pitavastatin 2-4 mg/d, Pravastatin 40 mg/d, Simvastatin 20-40 mg/d, or Xuezhikang 1.2 g/d), with or without concurrent cholesterol absorption inhibitors.
- 3) Baseline LDL-C levels failing to reach the therapeutic target corresponding to the patient's ASCVD risk categorization (defined as follows):ASCVD Primary Prevention (Low Risk): LDL-C ≥ 3.4 mmol/L；ASCVD Primary Prevention (Moderate/High Risk): LDL-C ≥ 2.6 mmol/L；ASCVD Secondary Prevention (Very High Risk): LDL-C ≥ 1.8 mmol/L OR reduction from baseline ≥ 50%；ASCVD Secondary Prevention (Ultra-High Risk): LDL-C ≥ 1.4 mmol/L OR reduction from baseline ≥ 50% 4) Meets the standard clinical criteria for PCSK9 inhibitor initiation, OR the treating physician estimates that continuing current moderate-intensity statins cholesterol absorption inhibitor therapy will not achieve the target LDL-C levels, thereby requiring combination therapy with a PCSK9 inhibitor.
- 5) First-time user of tafolecimab (PCSK9 inhibitor-naïve). 6) Voluntarily participates in the study, provides written informed consent, and meets all follow-up compliance requirements.
- 7) Candidates must meet ALL of the above criteria to be eligible for enrollment in the study.
Key exclusion criteria (11 listed)
- Marked liver function abnormalities at enrollment: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels 3 times or more above the upper limit of the normal reference range;
- Renal insufficiency at enrollment: serum creatinine levels above the upper limit of the normal reference range and/or endogenous creatinine clearance below the lower limit of the normal reference range;
- Severe heart failure: left ventricular ejection fraction ≤ 30%;
- Secondary dyslipidemia caused by factors such as thyroid dysfunction, nephrotic syndrome, or familial hyperlipidemia;
- Patients with connective tissue diseases, rheumatic or autoimmune diseases, rhabdomyolysis, hematologic disorders, or malignancies, combined with other types of intracranial diseases;
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 |
|---|---|---|
| TafolecimabAlso: 托莱西单抗150 mgSubcutaneous injection | Drug | Tafolecimab 150 mg Q2W, Tafolecimab 150 mg Q3W |
Primary outcome
Percent Change from Baseline in LDL-C at Week 12
Time frame: Baseline and Week 12
Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 12. Calculated as: (Week 12 value - Baseline value) / Baseline value × 100%.
4 secondary outcomes
Percent Change in Lipoprotein(a) from Baseline at Week 12
Time frame: Baseline and Week 12
LDL-C Target Achievement Rate
Time frame: At Week 2, 6, 12 (Q2W group) and Week 3, 9, 12 (Q3W group)
Changes in Other Lipid Parameters
Time frame: Baseline and each designated visit (through Week 12)
Safety and Tolerability Profile
Time frame: From first dose through Week 12
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 17 Jul 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Hyperlipidemia, run by Mei Gao 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 4 inclusion and 11 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 17 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Mei Gao (0531-89269317, lixinyan0514@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change from Baseline in LDL-C at Week 12 (time frame: 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 17 Jul 2026.