Full Service Clinical Development for Metabolic Diseases and Obesity
Start Fast. Scale Seamlessly.
The obesity and metabolic pipeline is moving faster than any therapeutic area in history — 600+ compounds in development, new mechanisms entering the clinic every quarter, and sponsors who need clean data on timelines that don’t slip.
We’re built for that pace.
Learn about our Metabolic & Obesity clinical development services
Our dedicated metabolic and obesity teams deliver:
- Early phase through Phase III continuity with the same senior team
- A 200-bed clinical pharmacology unit purpose-built for FIH through dose-finding
- Proven agility to pivot protocols, manage interim analyses, and accelerate end-of-study delivery
- Deep GLP-1, incretin, and next-generation anti-obesity drug expertise
From FIH to global registrational trials, we deliver metabolic and obesity programs with the scientific depth and operational speed your investors and your patients require.
Metabolic & Obesity Challenges We Solve Every Day
Results that matter to your timeline, pipeline, and investors.
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Seamless Early to Late Phase Continuity
We are the only CRO in the metabolic space offering integrated continuity from first-in-human through global Phase II/III, powered by our 200-bed San Antonio CPU, global site network, and dedicated metabolic teams that stay on your program from kickoff through database lock.
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Deep GLP-1 and Next-Generation Anti-Obesity Drug Expertise
From GLP-1 receptor agonists and GLP-1/GIP dual agonists to triple agonists, amylin combinations, and oral formulations, our teams have direct experience supporting clinical programs across incretin therapies. We understand the protocol design, endpoint selection, and regulatory needs these mechanisms require.
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Consistently Accelerated End-of-Study Delivery
We have a proven track record of completing end-of-study data packages ahead of contracted timelines across multiple metabolic and obesity programs. When your funding round or acquisition timeline depends on clean data, we deliver.
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Site Intelligence Built for Modern Obesity Populations
Our site networks track patients’ medical histories and longitudinal weight-management journeys, which are critical for recruiting post-GLP-1 plateau populations, healthy obese volunteers (BMI ≥30), and overweight cohorts. Strategic site selection informed by real patient pathways, not transactional clinic databases.
The Numbers Behind Our Metabolic Study Experience
Studies
Global Sites
Patients
Countries Across All Regions
Start Fast. Scale Seamlessly. Full Metabolic & Obesity Development Support.
Early Development
Phase I & Clinical Pharmacology
- FIH studies
- SAD/MAD
- PK/PD characterization
- Food effect and drug-drug interaction studies
- Bioequivalence studies
- Thorough QT (QTc) studies
- Normal healthy volunteer and healthy obese (BMI ≥30) recruitment
- Integrated bioanalytical laboratory (2,000+ validated methods)
Late Stage
Phase II–IV & Global Programs
- Global registrational trials
- Cardiovascular outcome trials (CVOTs) for obesity drugs
- Adaptive and complex trial designs
- Endpoint adjudication for MACE and composite endpoints
- Multi-country regulatory submissions (FDA, EMA, and PMDA)
- Real-world evidence and post-marketing studies
- Pediatric obesity and adolescent trial expertise
Metabolic-Specific Capabilities
Therapeutic Area Depth
- GLP-1, GLP-1/GIP, and triple agonist program support
- Oral anti-obesity medication development
- MASH/MASLD clinical trial design with non-invasive prescreening
- Type 1 and 2 diabetes programs
- Lipid disorders and metabolic syndrome
- CKM (cardiovascular-kidney-metabolic) syndrome trials
- Body composition endpoints (DXA/MRI)
- Digital biomarker integration
- Obesity-specific patient engagement and retention strategies
We Know What Metabolic & Obesity Sponsors Are Thinking
And we’ve built our model to address it head-on.
We hear this from every obesity biotech. Our governance model eliminates the weeks-long approval chains you’ve experienced at large CROs. We’ve pivoted entire trial plans in under a week — including interim analyses, protocol amendments, and ad hoc investor-driven data requests — without introducing delays. Your milestones become our milestones.
We run multi-country Phase III programs across our global site network. But unlike the large CROs, we do it without the operational drag, staff turnover, and handoffs that cost you months. We deliver leaner, smarter Phase III execution, the team at your bid defense is the team that runs your trial.
Our teams have supported clinical programs across the incretin landscape — GLP-1 receptor agonists, dual agonists, triple agonists, amylin combinations, and oral formulations. We understand the endpoint selection, weight regain dynamics, post-GLP-1 plateau populations, and cardiovascular outcome requirements that define this drug class.
We’re the only CRO in the metabolic space offering seamless continuity from FIH through global Phase III. Our 200-bed CPU handles your early phase work, and the same scientific and operational team transitions you to late-stage execution. No handoffs, no knowledge loss, no starting over.
What Metabolic Sponsors Say
Your experience is important to us.
Who We Partner With in Metabolic & Obesity
We understand that different sponsors have different pressures — and we’ve built our model around them.
Emerging Obesity Biotech
You’re developing a next-generation anti-obesity compound and every milestone matters to your investors. You need a CRO that compensates for a lean internal team, moves at the speed your funding demands, and delivers data that’s acquisition-ready. Senior attention from day one.
Large Pharma / Biosimilar Developers
Comparator arms | Biosimilar development | Line extensions
You need a specialized CRO for metabolic comparator arms, GLP-1 biosimilar programs, or indication-expansion studies that don’t justify your preferred vendor’s full machinery. We offer the therapeutic depth of a specialist with the infrastructure to deliver global programs.
Mid-Stage Biotech / Biopharma
Phase II-III | Multi-Asset Portfolio | Global Ambitions
You’re scaling from proof-of-concept to registrational trials and need a partner who can execute multi-country programs without the overhead and bureaucracy of a top-5 CRO. You need global reach with biotech-speed decision-making, and a team that won’t hand you off once the study starts.
Your Metabolic & Obesity Leadership Team
Alessandra Vignola
Senior Vice President, Cardiovascular & Metabolic
Seasoned pharmaceutical and clinical research leader with 30+ years experience guiding cardiometabolic programs across oncology, hematology, cardiovascular, endocrine, gastrointestinal, and immunology.
Juliana (Judith) Hey-Hadavi, DDS, MD, MSc
Vice President, Medical Affairs
Internationally recognized physician-executive with 20+ years’ leadership in global medical affairs, clinical innovation, and drug development across cardiovascular, metabolic, neurology, and immunology.
Casey Ustick
Therapeutic Strategy Lead, Metabolic
Therapeutic strategy leader in metabolic programs, integrating science, operations, and commercial insight to guide successful clinical development strategies.
MarieElena Cordisco, MA, APRN, NP-C
Senior Director, Therapeutic Strategy Lead, Metabolic
Clinical research leader and nurse practitioner with 20+ years’ experience in endocrinology and cardiometabolic trials, advancing patient-centered research and care.
Natalia Castro
Executive Director, Cardiovascular & Metabolic Business Unit
Executive director with 20+ years’ experience leading cardiovascular and metabolic clinical trials, specializing in obesity research, ensuring quality, compliance, and innovation.
Rafal Ziecina, MD, PhD
Executive Director, Scientific Solutions, Cardiovascular, Endocrine & Metabolic
Executive Director of Scientific Solutions with 20+ years’ pharmaceutical research experience leading cardiovascular and metabolic initiatives, regulatory strategy, safety, and development planning.
Sherilyn Adcock, RPh, PhD
Chief Scientific Officer, Early Phase Development
Chief Scientific Officer guiding early phase drug development, providing strategic insight to clinical teams and sponsors with decades of leadership experience.
Awards
Industry Standard Research (ISR) recognized Phase 2/3 CROs for comprehensive excellence across their capabilities, compatibility, expertise, quality, and reliability.
Worldwide Clinical Trials was named Most Innovative Clinical Research Organization (CRO) by the Triangle Business Journal (TBJ). This awards program celebrates the achievements of individuals and companies making critical advancements in pharmaceuticals, biotech, ag tech, and beyond, in the Triangle region of North Carolina.
Worldwide Clinical Trials, Inc., (Worldwide) the industry’s leading global, midsize, full-service contract research organization (CRO), has been recognized for excellence and honored in five categories in the 2022 CRO Leadership Awards, based on primary market research from Industry Standard Research (ISR) Reports and presented by Clinical Leader and Life Science Leader magazines. This marks the ninth consecutive year that Worldwide has been recognized as a high-performing CRO based on direct survey feedback from pharmaceutical and biotech professionals.
Start Fast. Scale Seamlessly. Your Metabolic Program Can’t Wait.
The metabolic and obesity pipeline moves fast. You need a CRO that’s already built for this pace.
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Response within 1 business day
Personalized, not automated -
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Talk to a metabolic expert
Matched to your therapeutic area and phase
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No obligation, no pressure
Honest assessment of fit
“I honestly felt like the RFP process with Worldwide Clinical Trails was the best experience that I’ve ever had with any CRO vendor going through the proposal process. Maybe that’s because their BD rep was just that responsive and that easy to work with.”
— Director of Clinical Operations, Small Biopharma Customer