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

Launched by RIBOCURE PHARMACEUTICALS AB · Jan 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RBD5044 to see if it can help treat mixed dyslipidemia, a condition where there are unhealthy levels of fats (like triglycerides and cholesterol) in the blood. The main goals are to find out if RBD5044 can lower triglyceride levels and to check for any side effects that participants might experience while taking the drug. Participants in the trial will receive either RBD5044 or a placebo (a pill that looks like the medication but has no active ingredients) on two occasions over 84 days and will have 11 clinic visits over 12 months for check-ups and tests.

To join the trial, participants need to be between 18 and 80 years old and have specific levels of triglycerides and cholesterol in their blood. They should be in generally good health and not have serious medical conditions that could interfere with the study. This trial is currently recruiting participants, and those who join can play an important role in helping researchers understand how effective and safe RBD5044 may be for treating mixed dyslipidemia.

Gender

ALL

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.