New drug aims to tame dangerous blood fats in heart patients

NCT ID NCT06797401

Disease control Sponsor: Ribocure Pharmaceuticals AB Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests an experimental drug called RBD5044 in 120 adults with mixed dyslipidemia, a condition where both cholesterol and triglycerides are high. Participants receive either the drug or a placebo twice over 12 months to see if it safely lowers triglyceride levels. The goal is to better control blood fats and reduce heart disease risk.

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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

About 120 people

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

Started

Jan 2025

Expected to finish

Sep 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 80 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: * Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent. * Male or female participants, aged 18 to 80 years inclusive. * Fasting TG level of ≥ 150 mg/dL (≥ 1.69 mmol/L) and \<499 mg/dL (5.61 mmol/L). * Fasting levels at screening of non-HDL-C ≥ 100 mg/dL (2.59 mmol/L), or low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL (1.8 mmol/L) after at least 4 weeks of stable diet and stable optimal statin therapy (+ or - ezetimibe) if indicated. * Body mass index between 18 and 40 kg/m2. Exclusion Criteria: * Any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical trial and/or put the participant at significant risk (according to the investigator's judgment) if he/she participates in the clinical trial. * Uncontrolled hypertension (blood pressure \>160/100 mmHg at screening). (If untreated, participant may be re-screened once hypertension is treated and controlled). * Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression, which require current pharmacological intervention. Participants with a history of severe depression who are no longer on medication. * Any of the following laboratory values at screening: Hepatic: ALT or AST \>2× ULN at screening, eGFR \<30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease \[MDRD\] equation) at Screening, HbA1c \>9.0% (or \>75 mmol/mol International Federation of Clinical Chemistry \[IFCC\] units) at screening. * Patients with a diagnosis of HBV, HCV or HIV at screening.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

4 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New drug aims to tame dangerous blood fats in heart patients

What the study statuses mean