RDX-002 for Triglycerides

Overseen By Trisha Stamp, PhD, PA-C

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Response Pharmaceuticals

Must not be taking: Diabetes drugs, Weight loss drugs

Disqualifiers: Diabetes, Cardiovascular events, Hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if drug RDX-002 works to treat high levels of fat (known as triglycerides, or TGs) in the blood in adults. It will also learn about the safety of drug RDX-002. The main question it aims to answer is if treatment with RDX-002 will lower triglycerides after a high-fat meal in patients who have recently stopped treatment with semaglutide or tirzepatide for obesity. The trial will also examine the effect of RDX-002 on body weight and fasting levels of cholesterol. Researchers will compare RDX-002 to a placebo (a look-alike substance that contains no drug) to see if RDX-002 works to reduce triglycerides. Participants will: Take drug RDX-002 or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking semaglutide or tirzepatide before starting. You can continue other medications, but recent changes in lipid-lowering drugs are not allowed. The protocol does not specify a washout period for other medications.

What data supports the idea that RDX-002 for Triglycerides is an effective drug?

The available research does not provide any data supporting the effectiveness of RDX-002 for Triglycerides. The studies mentioned focus on other drugs and conditions, such as blood clotting disorders and heart-related issues, but do not mention RDX-002 or its impact on triglycerides. ^{1 2 3 4 5}

What safety data exists for RDX-002 treatment?

The provided research does not mention RDX-002 specifically. However, it discusses bexarotene, a retinoid X receptor agonist, which is associated with side effects like hypertriglyceridemia and hypothyroidism. These side effects are relevant if RDX-002 is similar to bexarotene. The research highlights that hypertriglyceridemia is a common adverse effect in patients treated with bexarotene, and its severity can vary due to genetic and environmental factors. ^{6 7 8 9 10}

Is the drug RDX-002 a promising treatment for high triglycerides?

The information provided does not directly address the effectiveness of RDX-002 for treating high triglycerides. The articles focus on methods for measuring triglycerides, not on the drug's impact. Therefore, we cannot determine if RDX-002 is promising based on this data. ^{11 12 13 14 15}

Research Team

Trisha Stamp, PhD, PA-C

Principal Investigator

Nucleus Network

Eligibility Criteria

This trial is for adults with high blood fat levels who recently stopped taking semaglutide or tirzepatide for obesity. Participants will take RDX-002 or a placebo daily for 12 weeks and visit the clinic every 4 weeks.

Inclusion Criteria

12-lead ECG at Screening with no abnormalities that compromise safety

Willing and able to provide written informed consent prior to the conduct of any study specific procedures

I have lost 10% or more of my original weight with semaglutide or tirzepatide.

Exclusion Criteria

I have diabetes.

Total fasting TGs ≥400 mg/dL at Screening

Uncontrolled hypertension (SBP >160 mmHg and DBP >100 mmHg)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RDX-002 or placebo daily for 12 weeks to assess its effect on postprandial triglycerides, body weight, and fasting cholesterol levels

12 weeks

3 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RDX-002

Trial Overview The study tests if RDX-002 can lower triglycerides after a high-fat meal in patients no longer on GLP-1 agonists. It compares RDX-002's effects on post-meal triglycerides, body weight, and fasting cholesterol to a placebo.

Participant Groups

Group I: Investigational drug Experimental Treatment 1 Intervention

The effect of 12 weeks of treatment with RDX-002 on postprandial TGs, fasting levels of cholesterol, and body weight among patients who have recently discontinued treatment with the GLP-1 agonists, semaglutide or tirzepatide, for obesity.

Group II: Placebo Placebo Group 1 Intervention

Matching placebo

Who Is Running the Clinical Trial?

Response Pharmaceuticals

Lead Sponsor

Trials

9

Recruited

530+

Findings from Research

DX-9065a is a selective inhibitor of activated factor X (FXa) that shows protective effects against tumor-induced disseminated intravascular coagulation (DIC) in a rat model, indicating its potential as a therapeutic agent in cancer-related coagulopathy.

In doses of 0.03 and 0.1 mg/kg/hour, DX-9065a significantly prevented the decrease in plasma fibrinogen and platelet counts, suggesting it effectively counteracts the hypercoagulable state associated with solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A specific inhibitor of factor Xa, DX-9065a, exerts effective protection against experimental tumor induced disseminated intravascular coagulation in rats. Tanabe, K., Terada, Y., Shibutani, T., et al.[2019]

Subgroup analyses from the ROCKET AF study indicate that rivaroxaban is effective and safe for patients with moderate renal failure, heart failure, and diabetes, providing insights into its use in these specific clinical conditions.

The X-VeRT trial, which focused on patients undergoing electrical cardioversion while on new oral anticoagulants, adds valuable data to the understanding of rivaroxaban's efficacy and safety in managing atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rivaroxaban in non valvular atrial fibrillation: subgroups analysis]. Greco, C.[2016]

In a study involving 1,472 patients with deep-vein thrombosis (DVT), those treated with rivaroxaban reported significantly higher treatment satisfaction compared to those receiving enoxaparin/vitamin K antagonist therapy, as measured by the Anti-Clot Treatment Scale (ACTS).

Rivaroxaban not only reduced the perceived burden of anticoagulation treatment (mean ACTS Burdens score of 55.2 vs 52.6) but also showed a consistent improvement in patient-reported benefits over 12 months, indicating it may enhance overall patient experience in managing DVT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Bamber, L., Wang, MY., Prins, MH., et al.[2022]

CX3002, a new factor Xa inhibitor, was found to be safe and well-tolerated in a study involving 84 healthy participants, with no serious adverse effects reported.

The study demonstrated that CX3002 produced dose-related increases in anti-Xa activity, indicating its potential efficacy, and the pharmacokinetics were predictable, supporting further clinical investigations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics and exploratory exposure-response analysis of CX3002, a novel inhibitor of Xa, in Chinese healthy subjects. Chen, W., Ruan, Z., Lou, H., et al.[2023]

In a phase-I study involving 12 healthy subjects, the oral factor Xa inhibitor DU-176b significantly reduced thrombus formation by 28% and 21% at 1.5 and 5 hours post-dose, respectively, indicating its potential efficacy in preventing blood clots.

The study also found that DU-176b decreased thrombin generation by 28% at 1.5 hours, suggesting that its mechanism of action effectively inhibits clotting processes, which could be useful for monitoring in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antithrombotic effects of factor Xa inhibition with DU-176b: Phase-I study of an oral, direct factor Xa inhibitor using an ex-vivo flow chamber. Zafar, MU., Vorchheimer, DA., Gaztanaga, J., et al.[2019]

Bexarotene treatment inhibits the growth and migration of non-small cell lung cancer (NSCLC) cells while promoting their apoptosis, with a significant role played by the slc10a2 gene.

Overexpression of slc10a2 enhances the anti-cancer effects of bexarotene by activating the PPARγ signaling pathway, which leads to increased PTEN expression and decreased mTOR activity, further supporting its potential as a therapeutic target in NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bexarotene inhibits the viability of non-small cell lung cancer cells via slc10a2/PPARγ/PTEN/mTOR signaling pathway. Ai, X., Mao, F., Shen, S., et al.[2022]

UAB30, a novel RXR ligand, shows greater efficacy than bexarotene in inhibiting the growth of cutaneous T-cell lymphomas (CTCLs) by effectively targeting the G1 cell cycle checkpoint and increasing the stability of the cell cycle inhibitor p27kip1.

Unlike bexarotene, UAB30 does not elevate serum triglycerides or induce hypothyroidism, making it a potentially safer alternative for CTCL treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The retinoid X receptor agonist, 9-cis UAB30, inhibits cutaneous T-cell lymphoma proliferation through the SKP2-p27kip1 axis. Chou, CF., Hsieh, YH., Grubbs, CJ., et al.[2020]

SC401, a new ω-3 fatty acid formulation, demonstrated significantly higher bioavailability of EPA and DHA compared to Lovaza, achieving this with a lower dose of 1530 mg versus Lovaza's 3600 mg.

The study found that SC401 had a faster absorption rate, with a shorter time to peak concentration (Tmax) compared to Lovaza, indicating it may be more effective in delivering these essential fatty acids under low-fat feeding conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel ω-3 Acid Ethyl Ester Formulation Incorporating Advanced Lipid TechnologiesTM (ALT®) Improves Docosahexaenoic Acid and Eicosapentaenoic Acid Bioavailability Compared with Lovaza®. Lopez-Toledano, MA., Thorsteinsson, T., Daak, A., et al.[2019]

A 52-year-old woman experienced clinical inefficacy with Olevia(®) omega-3 treatment for high triglycerides, but showed improvement after switching to Esapent(®), indicating that not all omega-3 formulations are equally effective.

In vitro tests revealed significant differences in dissolution times among various omega-3 formulations, suggesting that formulation characteristics may impact their clinical efficacy and absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Omega-3 Formulations Yield to Diverse Clinical Response: A Case-Report. Gallelli, L., Michniewicz, A., Stefanelli, R., et al.[2019]

In a study of 116 patients with cutaneous T-cell lymphoma (CTCL) undergoing bexarotene therapy, 82.7% experienced hypertriglyceridemia, highlighting this as a common side effect of the treatment.

Genetic screening for polymorphisms in the APOA5 and APOC3 genes may help predict triglyceride levels during treatment, allowing for better patient selection and management of bexarotene therapy based on individual risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of APOA5 and APOC3 Genetic Polymorphisms With Severity of Hypertriglyceridemia in Patients With Cutaneous T-Cell Lymphoma Treated With Bexarotene. Cabello, I., Alia, P., Pintó, X., et al.[2020]

A new fluorometric assay can accurately measure triglycerides in very small amounts (nanomoles) by using a series of enzymatic reactions to produce a detectable fluorescent signal.

The assay is effective over a linear range of 0.05 to 35 nanomoles of triglycerides, making it a precise tool for triglyceride quantification in research and clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A fluorometric method for the determination of triglycerides in nanomolar quantities. Mendez, AJ., Cabeza, C., Hsia, SL.[2019]

A new method was developed to quantitatively analyze diacylglycerol and alkylacylglycerol in cultured cells, identifying 36 different molecular species in Madin-Darby canine kidney cells.

The analysis revealed that these cells contain specific amounts of diacylglycerol and alkylacylglycerol, predominantly consisting of monoenoic and saturated species, which could enhance our understanding of their roles as intracellular mediators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A method for the quantitative analysis of molecular species of alkylacylglycerol and diacylglycerol. Warne, TR., Robinson, M.[2019]

A new high-performance liquid chromatography method was developed to analyze triacylglycerols in menhaden oil, successfully identifying 137 different triacylglycerols with varying fatty acid compositions.

This study is the first to provide a detailed characterization of the triacylglycerol fraction in menhaden oil, which could have implications for understanding its nutritional and health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mass spectrometric elucidation of triacylglycerol content of Brevoortia tyrannus (menhaden) oil using non-aqueous reversed-phase liquid chromatography under ultra high pressure conditions. Dugo, P., Beccaria, M., Fawzy, N., et al.[2016]

A new fully enzymatic assay for measuring triglycerides was developed, utilizing triacylglycerol acylhydrolase and glycerol kinase to produce glycerol-3-phosphate, which is then converted to hydrogen peroxide for detection.

The method was rigorously evaluated for accuracy and precision, ensuring that each enzymatic reaction step is complete, and additional HPTLC and HPLC techniques were created to monitor the assay's performance effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reagent for the enzymatic determination of serum total triglycerides with improved lipolytic efficiency. Nägele, U., Hägele, EO., Sauer, G., et al.[2022]

A new assay for measuring triacylglycerol (TG) in cells and animal tissues allows for rapid and economical quantification of TG from multiple samples, making it efficient for research purposes.

The assay uses an organic extraction method that avoids expensive reagents and harmful solvents, ensuring a cost-effective and environmentally friendly approach to TG detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple and rapid method to assay triacylglycerol in cells and tissues. Schwartz, DM., Wolins, NE.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A specific inhibitor of factor Xa, DX-9065a, exerts effective protection against experimental tumor induced disseminated intravascular coagulation in rats. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

[Rivaroxaban in non valvular atrial fibrillation: subgroups analysis]. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics and exploratory exposure-response analysis of CX3002, a novel inhibitor of Xa, in Chinese healthy subjects. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Antithrombotic effects of factor Xa inhibition with DU-176b: Phase-I study of an oral, direct factor Xa inhibitor using an ex-vivo flow chamber. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Bexarotene inhibits the viability of non-small cell lung cancer cells via slc10a2/PPARγ/PTEN/mTOR signaling pathway. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The retinoid X receptor agonist, 9-cis UAB30, inhibits cutaneous T-cell lymphoma proliferation through the SKP2-p27kip1 axis. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

A Novel ω-3 Acid Ethyl Ester Formulation Incorporating Advanced Lipid TechnologiesTM (ALT®) Improves Docosahexaenoic Acid and Eicosapentaenoic Acid Bioavailability Compared with Lovaza®. [2019]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Different Omega-3 Formulations Yield to Diverse Clinical Response: A Case-Report. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Association of APOA5 and APOC3 Genetic Polymorphisms With Severity of Hypertriglyceridemia in Patients With Cutaneous T-Cell Lymphoma Treated With Bexarotene. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

A fluorometric method for the determination of triglycerides in nanomolar quantities. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A method for the quantitative analysis of molecular species of alkylacylglycerol and diacylglycerol. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Mass spectrometric elucidation of triacylglycerol content of Brevoortia tyrannus (menhaden) oil using non-aqueous reversed-phase liquid chromatography under ultra high pressure conditions. [2016]

14. Germany pubmed.ncbi.nlm.nih.gov

Reagent for the enzymatic determination of serum total triglycerides with improved lipolytic efficiency. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

A simple and rapid method to assay triacylglycerol in cells and tissues. [2021]