Could a monthly shot beat biweekly for lowering cholesterol?
NCT ID NCT07712042
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This study looks at two different dosing schedules of the drug tafolecimab—given every two weeks or every three weeks—in people with high cholesterol that isn't controlled by statins alone. Over 12 weeks, researchers will measure how much LDL (bad) cholesterol drops and how safe each schedule is. The goal is to see if a less frequent injection works just as well.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tafolecimab, an injectable PCSK9 inhibitor
- What this could lead to
- If successful, this could help identify a more convenient dosing schedule for tafolecimab, making it easier for patients to manage high cholesterol.
- What could go wrong
- This is a small, observational study without randomization, so results may be less reliable. The 12-week follow-up is short, and long-term benefits or risks are not assessed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: 1. 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; 2. 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; 3. Severe heart failure: left ventricular ejection fraction ≤ 30%; 4. Secondary dyslipidemia caused by factors such as thyroid dysfunction, nephrotic syndrome, or familial hyperlipidemia; 5. Patients with connective tissue diseases, rheumatic or autoimmune diseases, rhabdomyolysis, hematologic disorders, or malignancies, combined with other types of intracranial diseases; 6. Patients who have experienced an allergic reaction while taking oral statins or receiving Tafolecimab injections, as well as those with clear contraindications; 7. Patients with a history of major surgery or trauma, or who have developed severe acute or chronic infections during the follow-up period; 8. Pregnant women; 9. Patients with serious illnesses and a life expectancy of ≤3 months, such as those with malignant tumors; 10. 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. 11. Participants meeting any of the above criteria must be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Qianfoshan Hospital
Ji'nan, China
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