Metabolic & Obesity CRO
Clinical Development Support for Metabolic and Endocrine Diseases
Guided by a science-first approach, Lotus brings efficiency and experience to your clinical development programs. As a specialized CRO with a focus on metabolic and endocrine clinical research—including Obesity—our experts across the medical, operational, site, and support functions ensure your studies—from early through later phases—are prioritized and streamlined.
Studies Conducted
Metabolic Studies Conducted
Obesity Studies Conducted
Note: Statistics combine experience from both Lotus Clinical Research and Evolution Research Group’s network of clinical research sites
Let us put our experience in metabolic and endocrine clinical development to work for you.
The Lotus Difference in Metabolic and Endocrine Clinical Development
Faster Site Activation
With priority access to Evolution Research Group’s (ERG) highly sought-after, US-based sites, we can accelerate study startup with unparalleled operational efficiencies.
130,000+ participant profiles
Our in-house team actively refreshes and recruits from our expanding database of overweight and obese individuals. Our “Every Body Research” initiative provides a rich database of volunteers and patients to jump-start your trial.
Industry-leading Experts
Known for our scientific rigor, our Scientific Leadership Team (SLT) includes some of the industry’s leading experts in obesity and metabolic research.
Early Phase
Derisking an early phase product is a critical first step. Our experts can support proof of concept, proof of mechanism, and specialized testing in our Phase 1 Clinical Pharmacology Units.
FNIH Biomarkers Consortium
With membership in the FNIH Biomarkers Consortium and representation on the Metabolic Diseases Steering Committee, our subject matter experts are at the forefront of supporting these crucial development programs.
Obesity Task Force
Multi-Site Case Study: The FNIH NIMBLE Stage 2 Project
Lotus was selected to execute the FNIH NIMBLE Stage 2 project—a high-impact study designed to advance noninvasive biomarkers for assessing liver disease progression and therapeutic response in complex metabolic trials. This multi-site effort, conducted solely within ERG’s clinical research network, showcases our ability to deliver integrated, multi-site clinical research initiatives with rigorous data quality and operational excellence, and underscores our capacity to execute specialized, large-scale metabolic studies.
With science always at the forefront, our metabolic experts remain part of the project team throughout the study’s duration.
A Deeper Dive into Early Phase Clinical Development for Metabolic Research
Our dedicated Phase I Units offer over 400 beds and 20+ years of experience involving healthy volunteers and special populations. Our experience spans a broad range of clinical pharmacology studies including:
- First-in-human (FIH)
- Pharmacokinetics/pharmacodynamics (PK/PD)
- Single and multiple ascending doses (SAD/MAD)
- Drug-drug interactions (DDI)
- Bioequivalence/bioavailability (BE/BA)
- Human Abuse Potential (HAP)
- Food Effect
- QTc/TQT interval
- First to File studies
Advanced Testing Methods
- Glucose Clamps
- Oral Glucose and Mixed Meal Tolerance Testing
- Intravenous Glucose Tolerance Testing
- Insulin Tolerance Testing
- Maximum Pancreatic Stimulation Tests
- Graded Glucose Infusions
- Stable Isotope Dilution Methods
- De Novo Lipogenesis Testing
- Gastric Emptying by multiple modalities
- Universal Eating Monitor (UEM)
- Flow Mediated Dilation (FMD)
- Indirect Calorimetry
- Dual-energy X-ray absorptiometry (DEXA or DXA)
- Magnetic resonance imaging (MRI)
- Ultrasonography
- FibroScan®
- Biopsy (Liver, Adipose, Muscle, etc)
- Peripheral blood mononuclear cell (PBMC) collections
- Electroencephalography (EEG)
- Spot and serial cerebrospinal fluid (CSF) collections
A Deeper Dive into Obesity Drug Development
“The Obesity Task Force is like compiling an all-star team of experts in Obesity drug development. It gives Sponsors a huge advantage as we look cross-functionally at each study to ensure the protocol design, recruitment strategy, and regulatory landscape align to drive success. And it’s not a one-and-done. We’re reviewing each study every week—our approach is hands-on and collaborative.”
Composed of experts across therapeutic and operational domains, the task force integrates cutting-edge science, specialized medical oversight, and operational excellence to ensure the comprehensive success of obesity research projects. By fostering collaboration with thought leaders and industry stakeholders, we aim to shape the future of obesity drug development. By integrating clinical expertise with operational innovation, we remain agile and responsive to the rapidly evolving anti-obesity drug landscape.