A Multi-center, Randomized, Double-Blind, Placebo-Controlled Phase II Trial Evaluating the Efficacy and Safety of RBD5044 in Chinese Participants With Hypertriglyceridemia
The goal of this clinical trial is to learn if drug RBD5044 works to treat hypertriglyceridemia in adults. It will also learn about the safety of drug RBD5044. The main questions it aims to answer are: Does drug RBD5044 reduce the triglyceride levels? What medical problems may participants experience when taking drug RBD5044? Researchers will compare drug RBD5044 to a placebo to see if drug RBD5044 works to treat hypertriglyceridemia. Participants will: Receive RBD5044 or placebo twice during the trial (Day 1 and Day 84).
• The participants consented to participate in the clinical study and signed the informed consent form.
• Male or nonpregnant (who do not plan to become pregnant) nonlactating female participants aged 18 to 80 years inclusive.
• Established diagnosis of HTG and prior documented evidence (medical history) of fasting TG level ≥150 mg/dL (≥1.7 mmol/L) and \<500 mg/dL (\<5.7 mmol/L)
• Mean fasting TG level ≥150 mg/dL (≥1.7 mmol/L) and \<500 mg/dL (\<5.7 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period.
• Fasting LDL-C ≤130mg/dL (≤3.4 mmol/L) at screening
• Participants should be on standard of care lipid lowering medications per local guidelines (unless documented as intolerant or inappropriate as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels. If TG-lowering medication is used (including fibrates and prescription omega-3 fatty acids) then use and dosage must be stable since≥6 weeks prior to screening.
• Participants using any of SOC treatment (such as anti-diabetes, anti-hypertension, Thyroid hormone replacement therapy, TG-lowering therapies, PCSK9 inhibitors treatment, retinoids etc.) must be on a stable regimen for the specified duration prior and for the duration of study participation.
• Female participants of childbearing potential must also be willing to practice abstinence from heterosexual intercourse (only if this reflects their preferred and consistent lifestyle) 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 investigational medicinal product (IMP) to 90 days after study completion.