NASH/NAFLD
Medpace specializes in the design and conduct of global trials in gastroenterology and hepatology, including nonalcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Central Lab Services
| A2 Macroglobulin | C Peptide | Free Glycerol | NAS Calculation |
| Adiponectin Total | Chylomicrons | Fructosamine | NMR |
| Aldolase | CK18 M30 | G6PD | P1NP |
| ANGPTL3 | CK18 M65 | Ghrelin | PIIINP |
| ANGPTL4 | Cortisol Salivary | Glucose | Phosphatidylethanol |
| Anti TPO | CRP, hs | GLP-1 Active | Pro BNP |
| Apo A1 | CTX Beta Crosslaps | GLP-1 Total | Pro C3 |
| Apo B | Cystatin C | Hyaluronic Acid | Proinsulin |
| Apo B 48 | D Dimer | Haptoglobin | Pyruvic Acid |
| Apo B 100 | ELF Panel | IL1 beta | Resistin |
| Apo CII | Ferritin | IL6 | sLDL |
| Apo CIII | FIB4 Calculation | Insulin | TGF Beta 1 |
| APR Calculation | Fibrinogen | Lactate | TIMP-1 |
| Autotaxin | Fibronectin | Leptin | TNF alpha |
| Beta Hydroxybutyrate | Fibrotest | Lp(a) | Troponin I |
| Bile Acids Fraction | FGF-19 | Lipid Panel | Vitamin D 25 OH |
| Bile Acids Total | FGF-21 | MCP-1 | YKL-40 |
| C4 (7-alpha) | Free Fatty Acids | NAFLD Calculation |
Lipid Disorders, Cardiovascular, and Metabolic Diseases
Medpace’s central laboratories have unparalleled experience and expertise in the development of lipid and cardiovascular modifying therapies. Key staff involves doctors, managers, and technologists with considerable expertise in the area of central laboratory operations for the pharmaceutical industry and federally funded programs, from discovery and proof of concept through large, long term global lipid and cardiovascular trials.
- Since 1985, this core group has been part of central laboratory operations for virtually every successful New Drug Application (NDA) involving lipid modifying therapies including, but not limited to, all “statins”, apo B antisense, and omega-3 agents.
- Recently Medpace has provided efficacy analysis for two Proprotein convertase subtilisin/kexin type 9 (PCSK9) mAb inhibitors that supported acceptance of the FDA biologics license application (BLA), European & Global filing, and subsequent approvals by the FDA and EMEA.
- Medpace has been the global central laboratory for Phase I – IV trials involving numerous lipid altering mechanisms including Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition involving monoclonal antibodies, RNA interference, and fusion proteins, cholesterylester transfer protein (CETP) inhibition, Diacylglycerol Transferase (DGAT-1) inhibition, peroxisome proliferator-activated receptor (PPAR) agonism, omega-3 fatty acids, niacin analogs, and modifications of other biomarkers known to affect lipid metabolism such as Apo CIII and ANGPTL3 (angiopoietin-like 3).
Central Lab Services
| Apolipoprotein Analysis: AI, AII, AV, B (Total), B-48, B100, CII,
CIII, E |
LDL Cholesterol – (Friedewald, DeLong, Hopkins), “direct” or homogenous enzymatic method, PUC | PCSK9, total and free |
| Cholesteryl Ester Transfer Protein (CETP) Activity, Mass | Lipid Profile (Total Cholesterol, Triglyceride, HDL-C, LDL-C) | Phospholipids |
| Free Fatty Acids | Lipoprotein (a) | Prebeta-1 HDL |
| Free Glycerol | Lipoprotein-associated Phospholipase A2 (LpPLA2) Activity and Mass | Preparative Ultracentrifugation (PUC) for lipoprotein fractionation |
| HDL Cholesterol – Precipitation with dextran sulfate (reference method), “direct” or homogenous enzymatic method, Preparative Ultracentrifugation (PUC) | Oxidized LDL | Retinyl Palmitate |
Key Instrumentation
| Beckman Coulter AU Clinical Chemistry Analyzers |
| Beckman Optima Ultracentrifuges |
| Siemens BNII Nephelometers |
| Randox Daytona |
| Waters AcQuity UPLC H Class System |
All four central lab locations globally participate in and are certified in the CDC (Center for Disease Control and Prevention) Lipid Standardization Part III Program for total cholesterol, triglyceride, High-Density Lipoprotein Cholesterol (HDL-C), and Low-Density Lipoprotein Cholesterol (LDL-C). Many lipid trials require LDL-C by the gold standard reference method, preparative ultracentrifugation (PUC), which is performed in high volume at Medpace with over 2,000 analyses monthly. Determination of efficacy, and safety, necessitates an accurate evaluation of drug effect, without the confounder of inaccurate data due to a less than optimal laboratory methodology. Medpace labs will get involved early in a drug development program, to aid in the determination of the best method for a clinical trial.
Autoimmune and Inflammatory
Medpace’s central laboratories have an extensive selection of tests relevant to autoimmune and inflammatory diseases. There over 50 inflammatory biomarkers on a validated test menu. Assays are validated on specialized instrumentation as well as a large menu (>100) of validated ELISA assays and multiplexed assays.
Central Lab Services
| Alpha 1 Antitrypsin | APS (antiphospholipid syndrome) markers | Free Light Chains |
| Alpha 2 Macroglobulin | Calprotectin | Immunoglobulins |
| Amyloid A | Complement Testing (C3, C4, C4a, C5a, Bb) | Interleukins |
| Anti-Cardiolipins antibodies (IgA, IgG, IgM) | C-Reactive Protein (high and ultra-sensitivity) | Prealbumin |
| Anti-Double Stranded DNA (DsDNA) antibodies | Direct Antiglobulin (DAT) | Various cytokines, chemokines, and growth factors (see Medpace test menu) |
| Antinuclear Antibodies (ANA) | Enhanced Liver Fibrosis |
Key Instrumentation
| Advia Centaur XPT | Randox Daytona | Tecan Evolyzer |
| Mesoscale Discovery Quickplex SQ | Roche Immunoassay Analyzers | Tecan INFINITE |
| MSD Secto 6000 | Sebia Hydrasys | Tecan Sunrise |
| Phadia Immunoassay Analyzers | Siemens BNII Nephelometers | |
| Protein Simple Ella | Stago Compact |
Resources
At-A-Glance: Central Laboratories
Fact Sheet: Central Laboratories
Fact Sheet: Medpace Labs & IHMA
Video: Expect More from Your Central Lab
Webinar: Challenges and Considerations in Designing and Conducting Immuno-Oncology Clinical Research
Article: Non-statin Treatments for Managing LDL Cholesterol and Their Outcomes
Whitepaper: The Current Biomarker Landscape in Immuno-Oncology
Whitepaper: Non Invasive Biomarkers Of Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Whitepaper: A Central Laboratory – Harmonization of Data
Whitepaper: Effect of Hemolysis, Icterus and Lipemia on Chemistry Tests and Association between the Amount of Interfering Substances and LIH Indices
