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New drug SHR-1918 targets stubborn high cholesterol in rare disease

NCT ID NCT06723652

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tested the drug SHR-1918 in 55 people with homozygous familial hypercholesterolemia (HoFH), a rare genetic condition causing extremely high cholesterol. Participants received either the drug or a placebo, and researchers measured how much their LDL (bad) cholesterol dropped after 12 weeks. The goal is to see if SHR-1918 can safely lower cholesterol in patients who already take other lipid-lowering medications.

What this could mean

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

Active substance
SHR-1918 (a drug that lowers LDL cholesterol)
What this could lead to
If it works, this could provide a new treatment option for people with homozygous familial hypercholesterolemia, helping to lower their dangerously high cholesterol levels.
What could go wrong
This is a completed Phase 3 trial with only 55 participants, so results may not apply to everyone. The drug may cause side effects or fail to show meaningful benefit over existing treatments.

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

55 people

The number who actually took part.

Started

Feb 2025

Finished

Nov 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

12 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. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol 2. LDL-C ≥2.6mmol/L at the screening visit 3. Body weight ≥40 kg 4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment. Exclusion Criteria: 1. Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening 2. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%) 3. eGFR \<30ml/min/1.73m2 at the screening visit 4. CK \>5times ULN at the screening visit

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Conditions

The condition(s) this trial relates to.

homozygous familial hypercholesterolemia

As listed by the trial registrant

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

Homozygous familial hypercholesterolemia

Contacts and locations

Locations

  • The Second Xiangya Hospital of Central South University Hospital

    Changsha, Hunan, 410000, China

More trials for these conditions

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