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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

RBD5044 in Chinese Participants With Hypertriglyceridemia

A Multi-center, Randomized, Double-Blind, Placebo-Controlled Phase II Trial Evaluating the Efficacy and Safety of RBD5044 in Chinese Participants With Hypertriglyceridemia

RBD5044 in Chinese Participants With Hypertriglyceridemia (NCT07587788) is a Phase 2 interventional studying Hypertriglyceridemia, sponsored by Ribotek Biopharmaceuticals (Shandong) Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hypertriglyceridemia and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The participants consented to participate in the clinical study and signed the willing to sign a consent form form. 2. Male or nonpregnant (who do not plan to become pregnant) nonlactating female participants aged 18 to 80 years inclusive. 3. 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) 4. 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. 5. Fasting LDL-C ≤130mg/dL (≤3.4 mmol/L) at screening 6. 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. 7. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. The participants consented to participate in the clinical study and signed the informed consent form. 2. Male or nonpregnant (who do not plan to become pregnant) nonlactating female participants aged 18 to 80 years inclusive. 3. 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) 4. 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. 5. Fasting LDL-C ≤130mg/dL (≤3.4 mmol/L) at screening 6. 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. 7. 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. 8. 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. Exclusion Criteria: 1. 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. 2. Body mass index \>40 kg/m2 3. Uncontrolled hypertension (blood pressure \>160/100 mmHg at screening). If untreated, participant may be re-screened once hypertension is treated and controlled. 4. 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. 5. Any of the following laboratory values at screening: * Hepatic: ALT or AST \>2× ULN at screening, * Biliary obstruction or hyperbilirubinemia (ie, total bilirubin \>2 × ULN, except with a documented diagnosis of Gilbert's disease) at screening, * eGFR \<30 mL/min/1.73 m2 (using the Modification of Diet in Renal Disease \[MDRD\] equation) at Screening, 6. -HbA1c \>9.0% (or \>75 mmol/mol International Federation of Clinical Chemistry \[IFCC\] units) at screening. The participant will be excluded if they have diabetes and meet any of the following criteria: * Two HbA1c readings (≥4 weeks apart) during the screening period, with at least one reading \>9.0%. (If a participant is screen-failed based on HbA1c criteria, the investigator may optimize the anti-diabetic regimen and re-screen the participant.) * Any history of the following within 12 weeks prior to the screening period: diabetic ketoacidosis, diabetic decompensation/hyperosmolar hyperglycemic state, diabetes complications, recurrent infections, or hospitalization due to poor glycemic control. * For participants with insulin-dependent diabetes: Any change in basal insulin of more than ±10 units during the 12 weeks prior to Day 1, indicating an unstable insulin regimen. 7. Received any siRNA for lipids/TGs (other than inclisiran) within 365 days before Day 1. Administration of investigational drug and inclisiran must be separated by at least 4 weeks. 8. Any other siRNA or antisense oligonucleotide within 60 days or 5 target engagement half-lives (whichever is longer), or any other investigational product within 30 days or 5 target engagement half-lives (whichever is longer) before the first dose, with the exception that inclisiran is permitted if administered at least 4 weeks apart from the trial drug. 9. Participants who were positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCVAb), or human immunodeficiency virus antibody (HIVAb) at screening. 10. Clinically significant illness within 7 days before the first dose of the trial drug. A clinically significant illness is defined as one that is new or acutely worsened, requires intervention, may interfere with study assessments, or significantly increases the participant's risk. 11. Acute pancreatitis within 3 months prior to first investigational product administration. 12. Participants with a history of symptomatic gallbladder disease prior to the first dose (e.g., cholecystitis, choledocholithiasis, multiple gallstones, etc, unless cholecystectomy was performed at least 6 months prior). 13. History of malignancy within the past 5 years (with the exception of cured basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix), or currently under evaluation for a potential malignancy. 14. Any planned bariatric surgery or similar procedures to induce weight loss during the period starting at consent through EOS. 15. History of major surgery within 12 weeks or planned major surgery during the study 16. Planned coronary intervention (such as stent placement or heart bypass) during the study. 17. Acute or unstable myocardial ischemia (myocardial infarction, acute coronary syndrome, new angina pectoris, stroke, transient ischemic attack, or unstable congestive heart failure) within 6 months prior to screening or major cardiovascular surgery planned within 3 months after screening. 18. . Recent unstable or symptomatic cardiac arrhythmia requiring hospitalization (including any associated medication changes) within 90 days of the beginning of screening. 19. Alcohol abuse (men drinking more than 14 standard units per week, women drinking more than 9 standard units per week) within 3 months prior to screening. 1 standard unit containing 14g of alcohol, such as 360mL of beer or 45mL of spirits with 40% alcohol or 150mL of wine), or a positive alcohol B-PEth test, at the discretion of the investigator, is not suitable for participation in the study. 20. History or clinical evidence of drug abuse within the 12 months before screening. 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. 21. Donated more than 500 mL of blood within 56 days before the first dose of the trial drug. 22. Participants with severe allergies (multiple drug and food allergies), or allergies to GalNAc and antisense oligonucleotides (ASO) components are determined by the investigator to be unsuitable for participation in this study. 23. History of severe intolerance to subcutaneous (SC) injection (minor reactions are permitted, e.g. localized swelling or redness.). 24. 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. 25. Unwillingness to comply with lifestyle and diet management requirements. 26. Pregnant or breastfeeding participants or participants intending to become pregnant during the trial and within 90 days after study completion.

Treatments Being Tested

DRUG

RBD5044

Active drug

DRUG

Placebo

Placebo that is identical in appearance and volume to the dose of active IMP

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Daqing People's Hospital
Daqing, Heilongjiang, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Nanyang, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
Lishui Central Hospital
Lishui, Zhejiang, China
Peking University First Hospital
Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07587788), the sponsor (Ribotek Biopharmaceuticals (Shandong) Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07587788 clinical trial studying?

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 full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07587788?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07587788?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07587788. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07587788. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.