Evaluating RBD5044 for treating mixed dyslipidemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the efficacy and safety of RBD5044, a drug administered via subcutaneous injections, in adults with mixed dyslipidemia. Participants will be randomly assigned to receive either RBD5044 or a placebo in a 3:1 ratio across three different dose levels. The trial will involve 11 clinic visits over 12 months for checkups and blood tests, with the primary evaluation occurring at week 16. The study will monitor triglyceride levels and any potential medical issues arising from the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lunds Universitetssjukhus
  Lund, Sweden Recruiting
• Ribocure Clinic/Ribocure Pharmaceuticals AB
  Mölndal, Sweden Recruiting
• AkardoMedSite
  Stockholm, Sweden Recruiting
• Akademiska Sjukhuset Uppsala
  Uppsala, Sweden Recruiting

Study contacts

• Principal investigator: Sara Svedlund, MD, PhD — Ribocure Clinic/Ribocure Pharmaceuticals AB
• Study coordinator: Rebeckha Magnusson
• Email: rebeckha.magnusson@ribocure.com
• Phone: 0046317207800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.