Actively Recruiting
RBD5044 in Chinese Participants With Hypertriglyceridemia
Led by Ribotek Biopharmaceuticals (Shandong) Co., Ltd · Updated on 2026-05-14
40
Participants Needed
8
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
RBD5044 in Chinese Participants With Hypertriglyceridemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants signed informed consent.
- Male or nonpregnant, nonlactating females aged 18 to 80 years.
- Diagnosed with hypertriglyceridemia with fasting triglyceride levels between 150 mg/dL and less than 500 mg/dL.
- Mean fasting triglyceride levels confirmed at two visits 7 to 17 days apart during screening.
- Fasting LDL cholesterol less than or equal to 130 mg/dL at screening.
- On stable standard of care lipid-lowering medications or documented intolerance to them for at least 6 weeks before screening.
- Stable regimen for other treatments like anti-diabetes or anti-hypertension medications before and during the study.
- Female participants of childbearing potential must agree to abstinence or use highly effective contraception from 2 weeks before first dose to 90 days after study completion.
You will not qualify if you...
- Any uncontrolled or serious disease that may interfere with participation or pose significant risk.
- Body mass index over 40 kg/m2.
- Uncontrolled hypertension with blood pressure over 160/100 mmHg at screening.
- Active or history of serious mental illness requiring current medication.
- Elevated liver enzymes or bilirubin beyond specified limits.
- Estimated glomerular filtration rate below 30 mL/min/1.73 m2.
- HbA1c over 9.0% or unstable diabetes control.
- Recent use of siRNA or investigational drugs within specified timeframes.
- Positive tests for hepatitis B, hepatitis C, or HIV antibodies.
- Clinically significant illness within 7 days before first dose.
- Acute pancreatitis within 3 months prior to dosing.
- History of symptomatic gallbladder disease unless treated by surgery at least 6 months prior.
- History of malignancy within 5 years except certain skin or cervical cancers.
- Planned bariatric or major surgery during the study period.
- Recent or planned coronary interventions or major cardiovascular events within specified timeframes.
- Alcohol or drug abuse within recent months.
- Recent blood donation over 500 mL within 56 days before first dose.
- Severe allergies or intolerance to study drug components or subcutaneous injections.
- Any condition deemed unsuitable by the investigator.
- Unwillingness to comply with lifestyle and diet management.
- Pregnant, breastfeeding, or planning pregnancy during study and 90 days after.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
Daqing People's Hospital
Daqing, Heilongjiang, China
Actively Recruiting
2
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Actively Recruiting
3
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Actively Recruiting
4
Jingzhou Central Hospital
Jingzhou, Hubei, China
Actively Recruiting
5
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Nanyang, China
Actively Recruiting
6
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Actively Recruiting
7
Lishui Central Hospital
Lishui, Zhejiang, China
Actively Recruiting
8
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
F
Fei Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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