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New shot shows promise in lowering 'Bad' cholesterol in large trial

NCT ID NCT07295418

Disease control Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tested a new injectable drug called SAL003 in 618 adults with high cholesterol or mixed dyslipidemia. Participants received either SAL003 or a placebo every 4 weeks for 12 weeks, then all received SAL003 for another 40 weeks. The main goal was to see if SAL003 lowers LDL ('bad') cholesterol more than placebo. The trial is complete, but results are not yet available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAL003 (a PCSK9 inhibitor injection)
What this could lead to
If successful, SAL003 could offer a new injectable option to help lower 'bad' LDL cholesterol in people with high cholesterol, potentially reducing heart disease risk.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not prove superior to placebo or may have side effects. It is tested only in Chinese adults, so results may not apply to other populations.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

618 people

The number who actually took part.

Started

Oct 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

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: * Male or female, aged 18 to 75 years (inclusive). * Fasting LDL-C ≥2.6 mmol/L and \<4.9 mmol/L at screening/randomization. * Meets criteria based on the 2023 Chinese Lipid Management Guidelines (e.g., specific LDL-C levels with certain risk factors, or presence of diabetes). * Fasting triglycerides (TG) ≤5.6 mmol/L at screening/randomization. * Provides written informed consent. Exclusion Criteria: * Diagnosis of familial hypercholesterolemia (HoFH or HeFH). * History of atherosclerotic cardiovascular disease (ASCVD). * Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg). * Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c \>8.0%). * Significant hepatic or renal impairment. * Active liver disease or positive for HIV or Syphilis. * History of malignancy within 5 years prior to screening. * Use of any lipid-lowering drugs (statins, ezetimibe, etc.) or traditional Chinese medicines known to affect lipid metabolism within 3 months prior to screening. * Prior treatment with any PCSK9 inhibitor. * Known hypersensitivity to any component of the investigational product or history of severe allergy to antibody therapies. * Any other condition deemed by the investigator to be unsuitable for participation.

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Conditions

The condition(s) this trial relates to.

hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperlipidemias

Contacts and locations

Locations

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100083, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.