Could a monthly shot beat biweekly for lowering cholesterol?

NCT ID NCT07712042

Disease control Sponsor: Mei Gao Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Qianfoshan Hospital

    Ji'nan, China

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