In Vivo Pharmacology for Metabolic Disease
Obesity, dyslipidemia, Diabetes: type 1 and type 2, Liver (MASH), Diabetic complications: wound healing and retinopathy and metabolic syndrome, Validated disease models, comprehensive biomarkers, rapid IND advancement.
Executive Summary
Aragen’s In Vivo Pharmacology platform for metabolic disease delivers comprehensive preclinical efficacy testing specifically designed for obesity, Type 1, Type 2 diabetes, MASH, dyslipidemia, and related metabolic disorders. Our experienced team leverages validated disease models, rigorous study execution, and deep regulatory expertise to support IND submissions and clinical program advancement. With 150+ completed metabolic disease studies and 30+ years of experience, we understand the complex interplay of metabolic pathways and the translational biomarkers that predict clinical success.
Comprehensive Disease Model Portfolio
Diet-Induced Obesity (DIO)
60% high-fat diet-fed mice for anti-obesity efficacy assessment. Established metabolic dysfunction with chronic inflammation and insulin resistance.
Obesity-Induced Sarcopenia
Combined adiposity and progressive muscle loss assessment. Evaluates functional muscle decline in obese phenotype; grip strength measurement included.
Type 2 Diabetes & Glucose Metabolism
Insulin resistance and glycemic control models. OGTT, IPGTT, and ITT assays with AUC calculations for comprehensive glucose homeostasis evaluation.
Dyslipidemia & Lipid Disorders
Acute and chronic models of lipid metabolism dysfunction. Serum triglycerides, cholesterol, and comprehensive lipid profiling.
NASH/MASH Models
STZ-HFD, AMLN, CDAHFD, and Western Diet + CCl4 models. Advanced fibrosis assessment, steatosis quantification, and hepatic inflammation markers.
Metabolic Syndrome
Multi-parametric assessment of interconnected metabolic dysfunction. Simultaneous evaluation of obesity, glucose intolerance, dyslipidemia, and hepatic steatosis.
Renal Fibrosis
UUO (unilateral ureteral obstruction) and 5/6 nephrectomy models for chronic kidney disease (CKD). Glomerular filtration, proteinuria, and renal fibrosis biomarkers.
Flexible Study Design Capabilities
Proof-of-Concept (PoC) Studies
Acute and chronic dosing in single or multiple models. Rapid efficacy validation to support program progression decisions. Cost-effective for early-stage compounds.
Dose-Response & Optimization
ED50 determination, dose-limiting toxicity, PK/PD correlation. Optimal dose selection for clinical advancement. Statistical powering for regulatory readiness.
Mechanistic Studies
Target engagement, biomarker validation, pathway assessment. Deep understanding of mechanism of action. Supports mechanism-based clinical positioning.
Comparative Efficacy
Head-to-head comparison with reference compounds. Competitive differentiation. Benchmark against standard of care.
Combination Studies
Drug-drug interactions, synergistic efficacy evaluation. Polypharmacy approach optimization. Mechanistic understanding of combination benefits.
Special Population Studies
Sex-specific, age-matched, comorbidity models. Real-world patient heterogeneity representation. Predicts clinical population response variability.
Comprehensive Analytical Readouts
Body Composition & Metabolism:
TD-NMR (fat, lean, fluid mass %), indirect calorimetry, longitudinal body weight, food intake, grip strength.
Glucose & Insulin Metabolism
Fasting glucose/insulin, oGTT/ipGTT/ivGTT/ITT with AUC, HbA1c, C-peptide, proinsulin.
Lipid & Liver Health
Triglycerides, cholesterol, liver enzymes (AST, ALT), liver/adipose tissue weight, steatosis, triglyceride and hydroxproline content.
Specialized Biomarkers
Leptin, active GLP-1, PYY, acyl ghrelin, fecal fat, inflammatory cytokines, adipokines.
Histopathology & Tissue Analysis
H&E, Oil-Red-O, Masson’s trichrome, Picrosirius red, IHC, gene expression, hydroxyproline, digital pathology.
Advanced Imaging
TD-NMR based body composition, longitudinal monitoring, digital pathology.
Treatment Administration Routes
Oral (PO), Intraperitoneal (IP), Intravenous (IV), Subcutaneous (SC), Intramuscular (IM), Intradermal (ID), Intranasal, Sublingual, Osmotic Pumps, Nebulization. Supporting diverse modality types from small molecules to biologics and peptides.
Infrastructure & Capabilities
Global Facilities:
3 AAALAC-accredited facilities (US/India), quick space allocation, state-of-the-art vivarium, global logistics.
Scientific Excellence:
Experienced pharmacologists, DABT-certified toxicologists, advanced bioanalytical/DMPK scientists, regulatory experts.
Advanced Analytics:
TD-NMR, high-resolution imaging (MRI, Micro-CT, ultrasound), digital pathology, multiplex biomarkers (MSD, ELISA, HTRF).
