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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
RBD5044
DrugActive drug
Placebo
DrugPlacebo that is identical in appearance and volume to the dose of active IMP
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Low dose groupExperimental treatment 2 interventions
Group B: Medium dose groupExperimental treatment 2 interventions
Group C: High dose groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change from baseline in fasting serum triglyceride (TG) levels at week 16
Percent change from baseline in fasting serum TG levels at week 16
Time frame
From baseline to week 16Secondary outcomes
1
Change from baseline in fasting serum TG levels at different timepoints
Percent change from baseline in fasting serum TG levels at week 4, 8, 12, 20, 24, 30, and 36
Time frame
Week 4, 8, 12, 20, 24, 30, and 362
Change from baseline in lipid parameters levels at different timepoints
Percent change from baseline in LDL-C, TC, HDL-C, VLDL, non-HDL-C, TRL-C, ApoB, ApoA1, Lp(a) levels at week 4, 8, 12, 16, 24, 30, and 36
Time frame
Week 4, 8, 12, 16, 24, 30, and 363
Change from baseline in apoC-III levels at different timepoints
Percent change from baseline in apoC-III levels at week 4, 8, 12, 16, 20, 24, 30, and 36.
Time frame
Week 4, 8, 12, 16, 20, 24, 30, and 364
Plasma concentrations of RBD5044
Time frame
Within 24 hours before and after last IMP administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov