HypertriglyceridemiaPhase 2NCT07587788
RBD5044 in Chinese Participants With Hypertriglyceridemia
A Phase 2 study testing RBD5044 in people with Hypertriglyceridemia, run by Ribotek Biopharmaceuticals (Shandong) Co., Ltd at 7 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- RBD5044
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 7 sitesChina
- Study dates
- 28 Feb 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Any of the following laboratory values at screening:
- Hepatic: ALT or AST >2× ULN at screening,
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- 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,
- -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.
- 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.
- 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.
- 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.
- 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.
- Acute pancreatitis within 3 months prior to first investigational product administration.
- 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).
- 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.
- Any planned bariatric surgery or similar procedures to induce weight loss during the period starting at consent through EOS.
- History of major surgery within 12 weeks or planned major surgery during the study
- Planned coronary intervention (such as stent placement or heart bypass) during the study.
- 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.
- . Recent unstable or symptomatic cardiac arrhythmia requiring hospitalization (including any associated medication changes) within 90 days of the beginning of screening.
- 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.
- 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.
- Donated more than 500 mL of blood within 56 days before the first dose of the trial drug.
- 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.
- History of severe intolerance to subcutaneous (SC) injection (minor reactions are permitted, e.g. localized swelling or redness.).
- 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.
- Unwillingness to comply with lifestyle and diet management requirements.
- Pregnant or breastfeeding participants or participants intending to become pregnant during the trial and within 90 days after study completion.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University First Hospital
Beijing
Daqing People's Hospital
Daqing, Heilongjiang
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang
Jingzhou Central Hospital
Jingzhou, Hubei
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Nanyang
Yuncheng Central Hospital
Yuncheng, Shanxi
About this study
Official title: 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).
Read the detailed description
This is a multicentre, randomised, double-blinded, placebo-controlled, parallel-group phase 2 clinical trial to evaluate the efficacy and safety of RBD5044 subcutaneous injections in participants with hypertriglyceridemia.
All participants will be dosed at their trial site and undergo blood sampling and examinations at pre-defined timepoints.
Participants will be followed-up for 36 weeks from the first day of IMP/placebo administration. Primary endpoint evaluation will take place in week 16. End of trial is in week 36.
- Conditions
- Hypertriglyceridemia
- Being tested
- RBD5044, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBD5044Drug
Active drug
PlaceboDrug
Placebo that is identical in appearance and volume to the dose of active IMP
| Study group | Role | What they receive |
|---|---|---|
| Low dose group | Experimental | Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84 Receives: Drug: RBD5044; Drug: Placebo |
| Medium dose group | Experimental | Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84 Receives: Drug: RBD5044; Drug: Placebo |
| High dose group | Experimental | Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84 Receives: Drug: RBD5044; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in fasting serum triglyceride (TG) levels at week 16
Percent change from baseline in fasting serum TG levels at week 16
Measured: From baseline to week 16
Secondary outcomes (6)
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
Measured: Week 4, 8, 12, 20, 24, 30, and 36
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
Measured: Week 4, 8, 12, 16, 24, 30, and 36
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.
Measured: Week 4, 8, 12, 16, 20, 24, 30, and 36
Plasma concentrations of RBD5044
Measured: Within 24 hours before and after last IMP administration
Frequency, intensity and seriousness of the AEs during the trial
Number and percentage of participants with AEs. All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA)
Measured: Each visit from baseline to week 36 (end of trial)
Proportion of participants with positive immunogenicity response and descriptive statistics of anti-drug antibody (ADA) titer results
Measured: Week 4, 12, 16, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start28 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ribotek Biopharmaceuticals (Shandong) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587788
- Sponsor's protocol ID
- RB02T002
- Status last verified
- Aug 2026
- First submitted
- 4 May 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Placebo-Controlled Phase II Trial Evaluating the Efficacy and Safety of RBD5044 in Chinese Participants With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT07587788
- Acronym / sponsor ID
- RB02T002
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ribotek Biopharmaceuticals (Shandong) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a multicentre, randomised, double-blinded, placebo-controlled, parallel-group phase 2 clinical trial to evaluate the efficacy and safety of RBD5044 subcutaneous injections in participants with hypertriglyceridemia.
All participants will be dosed at their trial site and undergo blood sampling and examinations at pre-defined timepoints.
Participants will be followed-up for 36 weeks from the first day of IMP/placebo administration. Primary endpoint evaluation will take place in week 16. End of trial is in week 36.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose group | Experimental | Drug: RBD5044, Drug: PlaceboParticipants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84 |
| Medium dose group | Experimental | Drug: RBD5044, Drug: PlaceboParticipants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84 |
| High dose group | Experimental | Drug: RBD5044, Drug: PlaceboParticipants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (32 listed)
- 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.
- Any of the following laboratory values at screening:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBD5044Active drug | Drug | High dose group, Low dose group, Medium dose group |
| PlaceboPlacebo that is identical in appearance and volume to the dose of active IMP | Drug | High dose group, Low dose group, Medium dose group |
Primary outcome
Change from baseline in fasting serum triglyceride (TG) levels at week 16
Time frame: From baseline to week 16
Percent change from baseline in fasting serum TG levels at week 16
6 secondary outcomes
Change from baseline in fasting serum TG levels at different timepoints
Time frame: Week 4, 8, 12, 20, 24, 30, and 36
Change from baseline in lipid parameters levels at different timepoints
Time frame: Week 4, 8, 12, 16, 24, 30, and 36
Change from baseline in apoC-III levels at different timepoints
Time frame: Week 4, 8, 12, 16, 20, 24, 30, and 36
Plasma concentrations of RBD5044
Time frame: Within 24 hours before and after last IMP administration
Frequency, intensity and seriousness of the AEs during the trial
Time frame: Each visit from baseline to week 36 (end of trial)
Proportion of participants with positive immunogenicity response and descriptive statistics of anti-drug antibody (ADA) titer results
Time frame: Week 4, 12, 16, 24, and 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
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A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
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Pemafibrate for Symptomatic ICAS RCT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RBD5044 in people with Hypertriglyceridemia, run by Ribotek Biopharmaceuticals (Shandong) Co., Ltd at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in fasting serum triglyceride (TG) levels at week 16 (time frame: From baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.