Evaluating RBD5044 for treating mixed dyslipidemia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial Evaluating the Efficacy and Safety of RBD5044 in Patients With Mixed Dyslipidemia

This study is testing a new drug called RBD5044 to see if it can help adults with mixed dyslipidemia lower their triglyceride levels and improve their overall health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ribocure Pharmaceuticals AB (Industry-sponsored)
• Locations: 4 sites (Lund and 3 other locations)
• Trial ID: NCT06797401 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with specific triglyceride and cholesterol levels who are willing to comply with the study protocol.

Not a fit: Patients with uncontrolled hypertension or serious medical conditions that could interfere with the trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lipid profiles in patients with mixed dyslipidemia, potentially reducing cardiovascular risks.

How similar studies have performed: While there have been studies on dyslipidemia treatments, the specific approach with RBD5044 is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Lund and 3 other locations

• 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

Conditions Dyslipidemias; Mixed dyslipidemia