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New drug shows promise for rare High-Cholesterol disease

NCT ID NCT06009393

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tested an investigational drug called SHR-1918 in 26 people with homozygous familial hypercholesterolemia (HoFH), a rare genetic condition causing extremely high cholesterol. The study measured how much the drug lowered LDL (bad) cholesterol after 12 weeks. All participants continued their usual cholesterol medications during the trial.

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 (an investigational drug to lower cholesterol)
What this could lead to
If successful, SHR-1918 could offer a new treatment option to help control dangerously high cholesterol in people with this rare genetic condition.
What could go wrong
This is a small, early-phase trial with only 26 participants and no placebo group. Results may not apply to all patients, and the drug's long-term safety and effectiveness are not yet known.

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

26 people

The number who actually took part.

Started

Dec 2023

Finished

Aug 2024

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 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. 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.

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, 410007, China

More trials for these conditions

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