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Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals

ConditionHyperlipidemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMei Gao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tafolecimab

    Drug

    150 mgSubcutaneous injection

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Tafolecimab 150 mg Q2W1 intervention
Group B: Tafolecimab 150 mg Q3W1 intervention

Trial outcomes

Primary outcomes

1

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%.

Time frame
Baseline and Week 12

Secondary outcomes

1

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%.

Time frame
Baseline and Week 12
2

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).

Time frame
At Week 2, 6, 12 (Q2W group) and Week 3, 9, 12 (Q3W group)
3

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.

Time frame
Baseline and each designated visit (through Week 12)
4

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.

Time frame
From first dose through Week 12

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Qianfoshan Hospital Status unavailable Ji'nanChinaChina

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mei Gao

Lead sponsor

Qianfoshan Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: