RBD5044 in Chinese Participants With Hypertriglyceridemia
ConditionHypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRibotek Biopharmaceuticals (Shandong) Co., Ltd
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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). This may include, but is not limited to, for example, known diagnosis of Familial Chylomicronemia Syndrome (FCS), nephrotic syndrome, thyroid disease, uncontrolled hypertension, psychiatric disorder or unstable angina.
Body mass index >40 kg/m2
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.
Trial design
Treatments tested in this trial
- RBD5044
- Placebo
Treatment groups
40 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov