RBD5044 in Chinese Participants With Hypertriglyceridemia

NCT07587788 | Recruiting Phase 2 DMC

• 1 other identifier: RB02T002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief 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 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

Hypertriglyceridemia

Outcome Measures

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

  From baseline to week 16

Secondary Outcomes (6)

• Change from baseline in fasting serum TG levels at different timepoints

  Week 4, 8, 12, 20, 24, 30, and 36

• Change from baseline in lipid parameters levels at different timepoints

  Week 4, 8, 12, 16, 24, 30, and 36

• Change from baseline in apoC-III levels at different timepoints

  Week 4, 8, 12, 16, 20, 24, 30, and 36

• Plasma concentrations of RBD5044

  Within 24 hours before and after last IMP administration

• Frequency, intensity and seriousness of the AEs during the trial

  Each visit from baseline to week 36 (end of trial)

Study Arms (3)

Low dose group

EXPERIMENTAL

Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84

Drug: RBD5044; Drug: Placebo

Medium dose group

EXPERIMENTAL

Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84

Drug: RBD5044; Drug: Placebo

High dose group

EXPERIMENTAL

Participants will receive RBD5044 or placebo as subcutaneous injections at Day 1 and Day 84

Drug: RBD5044; Drug: Placebo

Interventions

RBD5044 DRUG

Active drug

High dose group; Low dose group; Medium dose group

Placebo DRUG

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

High dose group; Low dose group; Medium dose group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Ribotek Biopharmaceuticals (Shandong) Co., Ltd: lead

Study Sites (8)

Daqing People's Hospital

Daqing, Heilongjiang, China

RECRUITING

The Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

RECRUITING

Jingzhou Central Hospital

Jingzhou, Hubei, China

RECRUITING

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Nanyang, China

RECRUITING

Yuncheng Central Hospital

Yuncheng, Shanxi, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, China

RECRUITING

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Fei Xu

CONTACT

+86 10 62975531; xuf@ribolia.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 14, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)