RBD5044 SODIUM for Mixed dyslipidemia

Inclusion criteria

• {"criterion_text":"- Willingness to comply with protocol required visit schedule and visit requirements and provide written informed consent.\n- Male or female participants, aged 18 to 80 years inclusive.\n- Fasting TG level of ≥ 150 mg/dL (≥ 1.69 mmol/L) and <499 mg/dL (5.61 mmol/L).\n- 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\n- Body mass index between 18 and 40 kg/m2.\n- Female participants of childbearing potential must also be willing to practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or be willing to use a highly effective method of contraception (i.e., with a failure rate of < 1%/year) to prevent pregnancy from at least 2 weeks prior to the first administration of IMP to 4 weeks after the last administration of IMP. The following are considered highly effective contraceptive methods: •\tCombined (oestrogen and progestogen-containing) or progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, transdermal, intravaginal, injectable, or implantable). •\tIntrauterine device (IUD) or intrauterine hormone-releasing system (IUS). Female participants of non-childbearing potential are defined as pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhoea (in questionable cases a blood sample with detection of follicle stimulating hormone [FSH] >25 IU/mL will be confirmatory). Male participants must be willing, unless they have undergone vasectomy, to practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or use condoms from the first administration of IMP and until 4 weeks after the last administration of IMP to prevent pregnancy and drug exposure of a female partner."}

Exclusion criteria

• {"criterion_text":"- 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.\n- Clinically significant illness within 7 days before the first dose of the trial drug.\n- Consume more than 10 units of alcohol per week for male and female (unit: 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer) within the 12 months before screening or positive screen for excessive alcohol consumption (defined as b-PEth >0.30 µmol/l).\n- History or clinical evidence of drug abuse within the 12 months before screening or positive screen for drug abuse. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a dose reduction will lead to withdrawal symptoms.\n- Women of childbearing potential who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.\n- Donated more than 500 mL of blood within 56 days before the first dose of the trial drug.\n- History of severe intolerance to subcutaneous (SC) injection (minor reactions are permitted, e.g. localized swelling or redness.).\n- Any conditions which would make the participant unsuitable for enrollment or could interfere with the participant’s participation in or completion of the trial in the opinion of the investigator\n- Uncontrolled hypertension (blood pressure >160/100 mmHg at screening). (If untreated, participant may be re-screened once hypertension is treated and controlled).\n- 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.\n- 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.\n- Received an investigational product within 30 days or 5 half-lives (whichever is longer) before the first dose of the trial drug or are in the follow-up of another clinical trial.\n- Patients with a diagnosis of HBV, HCV or HIV at screening."}

Primary endpoints

• {"endpoint_text":"- Percent change from baseline in TG levels at week 16.","definition_or_measurement_approach":"Measured as percent change from baseline in triglyceride (TG) levels at week 16 compared to baseline (timepoint specified as week 16)."}

Secondary endpoints

• {"endpoint_text":"- Frequency, intensity and seriousness of the AEs during the trial. Clinically significant changes in laboratory parameters, vital signs, physical examinations and 12-lead ECG at each visit from baseline to week 48 (end of trial).","definition_or_measurement_approach":"Safety assessed by frequency, intensity and seriousness of adverse events; clinically significant changes in labs, vital signs, physical exam and 12-lead ECG at each visit through week 48."}
• {"endpoint_text":"- Percent change from baseline in TG levels at week 4, 8, 12, 20, 24, 32, 40 and 48.","definition_or_measurement_approach":"Measured as percent change from baseline in triglyceride (TG) levels at listed timepoints (weeks 4, 8, 12, 20, 24, 32, 40, 48)."}
• {"endpoint_text":"- Percent change from baseline in apoC-III levels at week 4, 8, 12, 16, 20, 24, 32, 40 and 48.","definition_or_measurement_approach":"Measured as percent change from baseline in apolipoprotein-CIII (apoC-III) levels at listed timepoints."}
• {"endpoint_text":"- Plasma concentrations of RBD5044 will be summarized with descriptive statistics by sampling collection time point.","definition_or_measurement_approach":"Pharmacokinetics: plasma concentrations summarized using descriptive statistics by sampling timepoint."}
• {"endpoint_text":"- Percent change from baseline in lipid parameters TC, LDL-C, HDL-C, non-HDL-C, TRL-C, ApoB, ApoA1, Lp (a) at week 4, 8, 12, 16, 20, 24, 32, 40 and 48.","definition_or_measurement_approach":"Measured as percent change from baseline in listed lipid parameters at specified timepoints."}

Sweden

Earliest CTIS Part Ii Submission Date

26-06-2024

Latest Decision Or Authorization Date

13-01-2026

Processing Time Days

566

Number Of Sites

5

Number Of Participants

120

Primary sponsor

Full Name

Ribocure Pharmaceuticals AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden