Study of RBD5044 in Adults with Mixed Dyslipidemia to Evaluate its Safety and Effectiveness

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What is this study about?

This clinical study focuses on people with Mixed Dyslipidemia, a condition where blood contains abnormal levels of different types of fats (lipids). The study will test a new medication called RBD5044, which is given as an injection under the skin. The purpose is to evaluate how well RBD5044 works and how safe it is for patients with mixed dyslipidemia.

During the study, participants will receive either RBD5044 or placebo injections for 48 weeks. The study will monitor various types of fats in the blood, including triglycerides, cholesterol, and other fat-related substances. Regular blood tests will be performed to measure these levels throughout the study period.

The medication being tested, RBD5044, belongs to a group of drugs called small interfering RNA. It is designed to help reduce the levels of certain fats in the blood that can be harmful when present in high amounts. Throughout the study, doctors will closely monitor participants’ health and any changes in their blood fat levels to determine if the treatment is working.

1 Initial assessment

Your participation begins with confirming that your fasting triglyceride level is between 150 and 499 mg/dL

Additional blood tests will check your cholesterol levels

Your body mass index must be between 18 and 40

2 Treatment assignment

You will be randomly assigned to receive either RBD5044 or a placebo

Neither you nor your doctor will know which treatment you are receiving

The medication will be given as a subcutaneous injection (under the skin)

3 Treatment period

The treatment period lasts for 48 weeks (approximately 11 months)

Your blood will be tested at weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48

Regular health checks will include physical examinations, vital signs, and heart monitoring (ECG)

The main assessment of the treatment’s effectiveness occurs at week 16

4 Safety monitoring

Throughout the study, your health will be monitored for any changes

Blood samples will be collected to measure medication levels in your body

Various blood fats (lipids) will be measured during each visit

5 Study completion

The study ends after the week 48 visit

A final health assessment will be performed

The study is expected to conclude by June 2026

Who Can Join the Study?

Must be willing to follow study schedule and requirements and provide written consent
Age must be between 18 and 80 years
Must have fasting triglyceride (TG) levels between 150 and 499 mg/dL (blood fats measured after not eating)
Must have specific levels of blood cholesterol after at least 4 weeks of stable diet and statin therapy:
- non-HDL cholesterol ≥ 100 mg/dL, or
- LDL cholesterol (bad cholesterol) ≥ 70 mg/dL
Body Mass Index (BMI) must be between 18 and 40 (measurement based on height and weight)
For women who can become pregnant:
- Must use highly effective birth control methods (less than 1% failure rate)
- Must use birth control from 2 weeks before starting study until 4 weeks after last dose
Women who cannot become pregnant must have either:
- Had specific surgical procedures (hysterectomy or removal of ovaries/tubes), or
- Been in menopause (no menstrual periods for 12 months)
For men:
- Must use condoms or practice abstinence during the study and for 4 weeks after last dose
- This requirement does not apply to men who have had a vasectomy

Who Cannot Join the Study?

Age below 18 years or above 65 years
History of severe allergic reactions to medications
Pregnancy or breastfeeding
Participation in another clinical trial within the last 30 days
Severe liver disease (conditions affecting proper liver function)
Severe kidney disease (conditions affecting proper kidney function)
Uncontrolled diabetes (blood sugar levels that are not well managed)
History of heart attack or stroke in the past 6 months
Active cancer or ongoing cancer treatment
Use of medications that could interact with the study drug
Uncontrolled high blood pressure (consistently high readings despite treatment)
History of substance abuse within the past year
Significant mental health conditions that could affect study participation
Any condition that, in the investigator’s opinion, could compromise patient safety during the study

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Akardo AB	Stockholm	Sweden
American Heart Of Poland S.A.	Kedzierzyn-Kozle	Poland
Lukmed 2 Sp. z o.o.	Siedlce	Poland
Linden Sp. z o.o. sp.k.	Cracow	Poland
Balsammedica Sp. z o.o.	Warsaw	Poland
Rjnqdgkr Psezmphqvdcmemw Ac	Molndal	Sweden
Uevwosm Umhgguojxt Herscsiv	Uppsala	Sweden
Ciiygcx Madchrdm Jiqvrrl Sno z oiyz	Warsaw	Poland
Ezf Zbljnk	Zamosc	Poland
Szwfuax Slgt	Kluczbork	Poland
Ees Ldoodw	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	13.01.2025
Sweden	Recruiting	13.01.2025

Trial locations

Investigated drugs:

Rbd5044 Sodium

RBD5044 is an investigational medication being studied for the treatment of mixed dyslipidemia, a condition where patients have abnormal levels of different types of fats (lipids) in their blood. This medication is being tested to see how well it can help manage various blood fat levels, including cholesterol and triglycerides. It’s currently in Phase 2 of clinical testing, which means researchers are working to determine if it’s both effective and safe for patients with this condition.

Investigated diseases:

Dyslipidaemia

Mixed Dyslipidemia – A condition characterized by abnormal levels of multiple lipids (fats) in the blood simultaneously. It involves elevated levels of triglycerides and LDL (bad) cholesterol, along with decreased levels of HDL (good) cholesterol. The condition develops gradually and can be influenced by both genetic factors and lifestyle choices. Mixed dyslipidemia affects the body’s ability to process and transport various types of fats properly through the bloodstream. The condition often occurs alongside other metabolic disorders and can persist for long periods if underlying causes are not addressed.

Trial ID:

2023-510369-92-00

Protocol code:

RC02T001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of RBD5044 in Adults with Mixed Dyslipidemia to Evaluate its Safety and Effectiveness

What is this study about?

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