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New shot helps lower cholesterol when statins aren't enough

NCT ID NCT06109831

Disease control Sponsor: Beijing Suncadia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new injectable drug called SHR-1918 in 335 people with high cholesterol that was not well controlled by their current statin therapy. Participants received either SHR-1918 or a placebo alongside their usual cholesterol medications. The main goal was to see how much their LDL (bad) cholesterol dropped after 16 weeks.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

335 people

The number who actually took part.

Started

Nov 2023

Finished

Jul 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: 1. Regularly taking any moderate-intensity or higher dose\* of statin stabilization therapy for ≥4 weeks at screening: 1. ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L; 2. ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L; 3. ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L. 2. Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose\* statin stabilization therapy for ≥4 weeks; a) Fasting LDL-C ≥ 2.6 mmol/L. 3. Fasting triglycerides ≤ 5.6 mmol/L. Exclusion Criteria: 1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%). 2. eGFR \<30ml/min/1.73m2 at the screening visit. 3. CK \>5times ULN at the screening visit.

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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.

Hyperlipidemic

Contacts and locations

Locations

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China