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.
12345What 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.
678910Is 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.
1112131415Eligibility 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.
+4 more
Exclusion Criteria
I have diabetes.
Total fasting TGs ≥400 mg/dL at Screening
Uncontrolled hypertension (SBP >160 mmHg and DBP >100 mmHg)
+18 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational drugExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Matching placebo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nucleus NetworkSaint Paul, MN
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Who Is Running the Clinical Trial?
Response PharmaceuticalsLead Sponsor
References
A specific inhibitor of factor Xa, DX-9065a, exerts effective protection against experimental tumor induced disseminated intravascular coagulation in rats. [2019](+)-2S-2-[4-[[(35S)-1-acetimidoyl-3-pyrrolidinyl]oxy]phenyl]-3-[7- amidino-2-napthyl]propanoic acid hydrochloride pentahydrate (DX-9065a) is an antithrombin III-independent, selective inhibitor of activated blood coagulation factor X (FXa). We investigated the protective effects of DX-9065a against tumor-bearing experimental disseminated intravascular coagulation (DIC) induced by the inoculation of AH-109A cells into rats. DX-9065a was subcutaneously administered at doses of 0.03 and 0.1 mg/kg/hour through an osmotic pump transplanted immediately after the inoculation of the tumor cells during the observation period. Platelet count decreased 12 days after the inoculation, concomitant with an increase in the thrombin-antithrombin III complex and fibrin and fibrinogen degradation products. Doses of 0.03 and 0.1 mg/kg/hour of DX-9065a significantly inhibited the decrease in plasma fibrinogen concentration and platelet count 13 days after the inoculation, respectively. These findings suggest that direct, selective inhibition of FXa by DX-9065a improves the hypercoagulable state induced by the progress of solid tumor.
[Rivaroxaban in non valvular atrial fibrillation: subgroups analysis]. [2016]After the ROCKET AF study main paper several subgroups analysis were recently published. These studies are useful to better evaluate the rivaroxaban efficacy and safety in different clinical conditions. Here the subgroup analysis of patients with moderate renal failure, heart failure and diabetes are presented. Post hoc data on patients who underwent an electrical or pharmacological cardioversion during ROKET AF follow up were available and here we analyze also the results of the first randomized study on electrical cardioversion in patients treated with new oral anticolagulants: the X-VeRT trial. A metanalysis of all the studies with rivaroxaban (one on stroke prevention in atrial fibrillation, two on acute coronary syndromes, four on deep venous thrombosis prophylaxis and two on pulmonary embolism treatment) with respect to the risk of myocardial infarction is examined.
Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. [2022]Rivaroxaban, an oral, direct factor Xa inhibitor, has been approved for the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE as a fixed-dose, single-drug regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. This study evaluated patient-reported treatment satisfaction in EINSTEIN DVT--a large, open-label, randomised study that compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy in patients with acute symptomatic DVT without PE. As part of EINSTEIN DVT, a total of 1,472 patients in seven countries were asked to complete a new, validated measure of treatment satisfaction--the Anti-Clot Treatment Scale (ACTS)--at scheduled visits throughout 12 months of treatment. ACTS scores were compared between study groups in the intention-to-treat population. Patients reported greater satisfaction in the rivaroxaban group compared with the enoxaparin/VKA group, with higher mean ACTS scores across visits. Mean ACTS Burdens scores were 55.2 vs 52.6 (p
Safety, pharmacokinetics and exploratory exposure-response analysis of CX3002, a novel inhibitor of Xa, in Chinese healthy subjects. [2023]CX3002 is a structurally novel inhibitor of factor Xa, with promising prospects. This study aims to report the results of a first-in-human ascending-dose study of CX3002 in Chinese healthy subjects, and to establish an exploratory population pharmacokinetic/pharmacodynamic (PK/PD) model to investigate the exposure-response relationship of CX3002.
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]Direct and specific inhibition of factor Xa is an emerging therapeutic strategy for atherothrombotic disease. Parenteral factor Xa inhibitors promise efficacy comparable to standard therapies, which could be extended to ambulatory patients with oral agents. We evaluated the antithrombotic effect of the oral, direct factor Xa inhibitor DU-176b in a phase-I study. Healthy subjects (n = 12) received a single, 60 mg dose of DU-176b. Antithrombotic effects were assessed by comparing ex-vivo thrombus formation at 1.5, 5, and 12 hours post-dose versus baseline, along with factor Xa activity, thrombin generation and clotting parameters. Under venous flow after 1.5 and 5 hours, the thrombus was 28% and 21% smaller versus baseline, respectively (p
Bexarotene inhibits the viability of non-small cell lung cancer cells via slc10a2/PPARγ/PTEN/mTOR signaling pathway. [2022]Thirty to 40 % of non-small cell lung cancer (NSCLC) patients developed higher hypertriglyceridemia in the process of treatment with bexarotene. And bioinformatics studies discovered that the expression of slc10a2 was increased in high-grade hypertriglyceridemia patients. So, we will explore the mechanism which may involve in this process.
The retinoid X receptor agonist, 9-cis UAB30, inhibits cutaneous T-cell lymphoma proliferation through the SKP2-p27kip1 axis. [2020]Label="BACKGROUND" NlmCategory="BACKGROUND">Bexarotene (Targretin®) is currently the only FDA approved retinoid X receptor (RXR) -selective agonist for the treatment of cutaneous T-cell lymphomas (CTCLs). The main side effects of bexarotene are hypothyroidism and elevation of serum triglycerides (TGs). The novel RXR ligand, 9-cis UAB30 (UAB30) does not elevate serum TGs or induce hypothyroidism in normal subjects.
A Novel ω-3 Acid Ethyl Ester Formulation Incorporating Advanced Lipid TechnologiesTM (ALT®) Improves Docosahexaenoic Acid and Eicosapentaenoic Acid Bioavailability Compared with Lovaza®. [2019]Label="PURPOSE" NlmCategory="OBJECTIVE">The US Food and Drug Administration has approved several highly purified ω-3 fatty acid prescription drugs for the treatment of severe hypertriglyceridemia. These differ in the amounts and forms of docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). This study compared the bioavailability of SC401 (1530 mg EPA-ethyl esters [EEs] and DHA-EEs plus Advanced Lipid Technologies⁎ [ALT†], a proprietary lipid-delivery platform to improve absorption), with. Lovaza‡ (3600 mg ω-3, primarily EPA-EEs and DHA-EEs) under low-fat feeding conditions.
Different Omega-3 Formulations Yield to Diverse Clinical Response: A Case-Report. [2019]Treatment guidelines recommend omega-3 with Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA) content not above 85% in patients with high plasma levels of triglycerides. Since the different up to date formulation of omega-3 available in commerce must be similar to clinical efficacy and safety, herein, we report the case a 52-year-old woman who presented clinical inefficacy using Olevia(®) omega-3 treatment. Clinical evaluation excluded the presence of intestinal or systemic diseases able to reduce the drug absorption. Switching the therapy from (Olevia(®)) to an equivalent omega-3 formulation (Esapent(®)), we documented a decrease in her plasma triglycerides levels. In order to evaluate a possible difference between these formulations we performed a single blind in vitro dissolution test using three pills for each formulation of omega-3 (Olevia(®), Esapent® and another one chosen between the several formulations available in commerce: DOC Generic(®)) that revealed a significant difference (>20%) in the dissolution time of three different omega- 3 commercially available drug formulation.
Association of APOA5 and APOC3 Genetic Polymorphisms With Severity of Hypertriglyceridemia in Patients With Cutaneous T-Cell Lymphoma Treated With Bexarotene. [2020]Hypertriglyceridemia is the most frequent and limiting adverse effect of bexarotene therapy in cutaneous T-cell lymphoma (CTCL). Despite standard prophylactic measures, there is a wide variability in the severity of this complication, which could be associated with both genetic and environmental factors.
A fluorometric method for the determination of triglycerides in nanomolar quantities. [2019]A fluorometric assay for triglycerides in nanomole quantities is described. Glycerol is liberated from triglycerides with lipase from Chromobacter viscosum, then converted by glycerol kinase to glycerol-3-phosphate, which is oxidized by glycerol-3-phosphate oxidase, producing H2O2. The H2O2 ultimately forms a peroxidase-catalyzed fluorogen with p-hydroxyphenylacetic acid. The excitation and emission wavelengths of the fluorogen are 325 and 415 nm, respectively. The assay is linear in the range 0.05-35 nmol of triglycerides using triolein as standard.
A method for the quantitative analysis of molecular species of alkylacylglycerol and diacylglycerol. [2019]We describe a method for the quantitative analysis of molecular species of diacylglycerol and alkylacylglycerol as their diradylglycerobenzoate derivatives. Synthetic internal standards were used to provide quantitative determinations of the low levels of diacylglycerol and alkylacylglycerol and their individual molecular species in cultured cells. Diradylglycerols were isolated by thin-layer chromatography (TLC), converted to their benzoate derivatives and separated into subclasses by TLC. The molecular species of each subclass were analyzed by reversed-phase high performance liquid chromatography. Thirty-six species of diglyceride-type molecules were identified in Madin-Darby canine kidney cells. These cells were shown to contain 7.88 nmoles of diacylglycerol and 3.97 nmoles of alkylacylglycerol per mumole of phospholipid. Both subclasses contain predominantly monoenoic and saturated species. This technique should be valuable for studies examining the origin and metabolism of these important intracellular mediators.
Mass spectrometric elucidation of triacylglycerol content of Brevoortia tyrannus (menhaden) oil using non-aqueous reversed-phase liquid chromatography under ultra high pressure conditions. [2016]A non-aqueous reversed phase high performance liquid chromatography method was developed, and optimized for triacylglycerol analysis in a Brevoortia tyrannus (menhaden) oil sample. Four columns were serially coupled to tackle such a task, for a total length of 60 cm of shell-packed stationary phase, and operated under ultra high pressure conditions. As detection, positive-ion atmospheric pressure chemical ionization mass spectrometry was used to attain identification of the analyzed sample components. A number of 137 triacylglycerols containing up to 19 fatty acids, with 14-22 carbon atom alkyl chain length and 0-6 double bonds, were positively identified in the complex lipidic sample. This is the first work that reports an extensive characterization of the triacylglycerol fraction of menhaden oil.
Reagent for the enzymatic determination of serum total triglycerides with improved lipolytic efficiency. [2022]A fully enzymatic assay is described for the determination of triglycerides. The coupled activities of triacylglycerol acylhydrolase and glycerol kinase result in the formation of glycerol-3-phosphate. The system also contains L-alpha-glycerol-phosphate oxidase, which produces hydrogen peroxide from glycerol-3-phosphate, and a sensitive chromogenic indicator system, consisting of peroxidase, 4-chlorophenol and 4-aminophenazone. We evaluated this method with respect to kinetics, linearity, blank rates, precision, accuracy, reagent stability and interfering substances. The accuracy of the triglyceride assay demands that each enzymatic reaction step be complete and homogeneous. We therefore developed HPTLC-1) and HPLC-2) methods to monitor the course and completeness of each step.
A simple and rapid method to assay triacylglycerol in cells and tissues. [2021]We have developed a reliable, rapid, and economical assay for the quantification of triacylglycerol (TG) in cells and animal tissues. In a few hours, this assay quantifies microgram amounts of TG from tens or even hundreds of samples. The protocol includes an organic extraction to partition TG away from proteins and other hydrophilic molecules found in cells and tissues that may interfere with the colorimetric enzyme-linked TG detection method. In addition, this assay is economical, as no expensive reagents, supplies, or equipment are needed. Another benefit of this assay is that it does not require environmentally unfriendly halogenated solvents.