Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT06797401

Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia

Led by Ribocure Pharmaceuticals AB · Updated on 2026-03-12

120

Participants Needed

4

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if drug RBD5044 works to treat mixed dyslipidemia in adults. It will also learn about the safety of drug RBD5044. The main questions it aims to answer are: Does drug RBD5044 reduce the triglyceride levels? What medical problems may participants experience when taking drug RBD5044? Researchers will compare drug RBD5044 to a placebo to see if drug RBD5044 works to treat mixed dyslipidemia. Participants will: Receive RBD5044 or placebo twice during the trial (Day 1 and Day 84). Visit the clinic 11 times during 12 months (visit every 4-8 weeks) for checkups and tests.

CONDITIONS

Official Title

Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to comply with visit schedule and provide written informed consent
  • Male or female participants aged 18 to 80 years inclusive
  • Fasting triglyceride level of 150 to less than 499 mg/dL
  • Fasting non-HDL cholesterol level at least 100 mg/dL, or LDL cholesterol at least 70 mg/dL after stable diet and optimal statin therapy for at least 4 weeks if indicated
  • Body mass index between 18 and 40 kg/m2
Not Eligible

You will not qualify if you...

  • Any uncontrolled or serious disease or medical/surgical condition that may interfere with participation or pose significant risk
  • Uncontrolled hypertension with blood pressure over 160/100 mmHg at screening (may be re-screened if treated and controlled)
  • Active or history of serious mental illness requiring current medication, including schizophrenia, bipolar disorder, or severe depression
  • Liver enzyme levels ALT or AST more than twice the upper limit of normal at screening
  • Kidney function eGFR below 30 mL/min/1.73 m2 at screening
  • HbA1c above 9.0% (or above 75 mmol/mol IFCC units) at screening
  • Diagnosis of hepatitis B, hepatitis C, or HIV at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Lunds Universitetssjukhus

Lund, Sweden

Actively Recruiting

2

Ribocure Clinic/Ribocure Pharmaceuticals AB

Mölndal, Sweden

Actively Recruiting

3

AkardoMedSite

Stockholm, Sweden

Actively Recruiting

4

Akademiska Sjukhuset Uppsala

Uppsala, Sweden

Actively Recruiting

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Research Team

R

Rebeckha Magnusson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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