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New injection targets hidden heart risk in early trial

NCT ID NCT07551505

Disease control Sponsor: Bisirna Therapeutics (Suzhou) 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This early-stage study tests a single dose of BSA204, an experimental injection, in 40 Chinese adults with borderline high lipoprotein(a) – a fatty substance linked to heart disease. The main goal is to check safety and side effects, while also measuring changes in cholesterol levels after six months. Because it's a Phase 1 trial, success is not guaranteed, but results could guide future research.

What this could mean

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

Active substance
BSA204 injection
What this could lead to
If safe and effective, BSA204 could become a new treatment to lower high lipoprotein(a) levels, potentially reducing heart disease risk.
What could go wrong
This is a very early Phase 1 trial with only 40 people. It primarily checks safety, not effectiveness. Many drugs fail at this stage.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

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

Started

Apr 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Body mass index (BMI) 18 to 30 kg/m2 * Fasting triglycerides (TG) ≤ 4.5 mmol/L * Borderline elevated fasting lipoprotein(a) \[Lp(a)\] levels as defined in the protocol * Fasting low-density lipoprotein cholesterol (LDL-C) within the range specified for the assigned dose cohort * o clinically significant abnormalities of hepatic or renal function Exclusion Criteria: * Pregnant or lactating women. * History or presence of significant medical conditions * Abnormal ECG findings, including a prolonged QTcF interval (\> 450 msec for males or \> 470 msec for females) * Prior treatment with small interfering RNA (siRNA) or antisense oligonucleotides within 12 months, or recent use of specific lipid-lowering therapies * Known allergy to any component of the study drug

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Conditions

The condition(s) this trial relates to.

Dyslipidemias hyperlipidemia inherited lipid metabolism disorder

As listed by the trial registrant

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

Dyslipidemias

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

More trials for these conditions

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