Adipositas
Advance your obesity-related clinical research
Maximize early differentiation in your obesity product with comprehensive, cross-functional expertise for diverse recruitment and simplified and compliant trial conduct.
Make your product stand out
Access specialized expertise to help differentiate your novel anti-obesity drug or device.
Connect with experts and sites
Tap into our comprehensive database and strong network including the highest performing sites and countries for obesity clinical trials.
Ease patient and site burden
Apply our deep operational experience to maximize your recruitment and retention—including strategies to enroll a diverse patient population.
Differentiate your anti-obesity product
Fortrea designs and executes complex, compliant obesity trials that help you reveal early differentiation in the obesity pipeline. We understand the importance of improving the quality of weight loss and preserving lean body mass (LBM) in weight management treatment to optimize the value of your asset.
Diverse patients for accurate representation
With notable differences in obesity observed by race and ethnicity—U.S. rates range from Black adults (49,9 %), Latino adults (45,6 %) and non-Hispanic white adults (41,4 %)1—it’s essential to support your diversity goals. To date, Fortrea has led the way, completing ~15 % of all Diversity Action Plans to the FDA. Our team can write and implement your Diversity Action Plan to meet regulatory requirements and help ensure your obesity trial includes an accurate representation of your product’s target patient population.
Expertise to achieve the next obesity breakthrough
Experience counts when it comes to placing patients’ needs at the forefront of your decisions and ensuring the success of your study.
-
Global clinical experience
Our global clinical experience across endocrinology spans 456 studies in 64 countries, involving 8.482 sites and more than 81.000 patients and our obesity experience includes monogenic obesity, rare etiologies and pediatric obesity.
-
Therapeutic, medical and operational expertise
Our experts bring a wealth of benefits to your obesity studies:
- Cross-functional expertise, including rare etiologies and pediatric obesity
- Consulting expertise to optimize your trial spanning regulatory strategy, biostatistical, medical, clinical pharmacology services, operational strategy and project management
- Enhanced site selection and enrollment with comprehensive database to select the highest-performing sites and countries and KOL and investigator relationships to boost enrollment
- Recruitment and retention programs to diversify and accelerate your study while maintaining focus on patient safety and quality data
-
Patient-centric solutions for better trials
We accelerate your trials by aligning patient study participation with their everyday activities reducing the stigma associated with chronic conditions like obesity. We also lower study burden for patients and sites with enabling technology like:
- Televisits
- ePRO
- study companion apps
- e-visit reminders
Obesity experience that matters
In the last 5 years, we have supported:
Our experts
Delivering obesity research expertise
Eine einzigartige Partnerschaft beginnt mit einem erfahrenen Team. Browse the bios of our featured team members.
Claudia Filozof, MD, PhD
Vice President and Therapeutic Area Head in Obesity, MASH and Liver indications
Claudia is Board Certified in nutrition and metabolism and offers 20+ years of pharmaceutical and CRO experience in Phase II-IV clinical research. Claudia joined Fortrea (previously Labcorp Drug Development) in 2014 and started building the Liver Therapeutic Area. She is currently heading the Liver medical team, responsible for the medical oversight and for providing strategic medical consultation. She is also chairing the Innovative Study Design working group. Claudia has comprehensive experience in leading drug development programs with her main focus in metabolics and liver indications.
Claudia is a member of the Liver and PSC Forum, AASLD steatohepatitis working group and EASL NAFLD group. She has authored multiple manuscripts, including five recent review papers about clinical development in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and adaptive design studies.
Peter Alfinito, PhD
Executive Director, Strategic Delivery and Growth
Peter has more than 20 years advancing drug development in the pharmaceutical industry and been with Fortrea (formerly Labcorp and Covance) for nine years. Peter has designed the clinical plan for more than 25 MASH/MASLD (metabolic dysfunction-associated steatohepatitis and metabolic dysfunction-associated steatotic liver disease) trials ranging from Phase Ib through Phase III/IV. He also brings experience in rare liver diseases such as Primary Sclerosing Cholangitis and Primary Biliary Cholangitis. Peter maintains key relationships for Fortrea with liver industry experts and networks to facilitate the smooth transition of trials, spanning the design stage to the operational stage.
Plamen Penev, MD, PhD
Executive Medical Director
Plamen Penev, MD, PhD, is a Board-Certified endocrinologist and Executive Medical Director leading a group of five other endocrinologists in the Cardiovascular, Metabolic, Endocrine and Renal therapeutic areas at Fortrea.
Dr. Penev completed his PhD training at Northwestern University, followed by residency in Internal Medicine at Saint Louis University and fellowship in Endocrinology at the University of Chicago and has over 25 years of combined patient care and clinical research experience in academia and industry.
Mala Puri, MD
Senior Medical Director
Mala Puri, MD, is a Board-Certified Pediatric Endocrinologist and Senior Medical Director focused in the Cardiovascular, Metabolic, Endocrine and Renal therapeutic areas at Fortrea. Dr. Puri completed her residency training and fellowship in Pediatric Endocrinology at the Children's Hospital at Montefiore, New York and has over 20 years of combined clinical and research work in academia and industry including significant experience in global pediatric and rare disease studies.
Michiel Koeijvoets
Executive Director, Global Project Delivery, Biopharma
Michiel has more than 21 years of drug development and clinical research experience in both pharma and CROs. He joined Fortrea (then Covance) in 2011 as a lead CRA on global trials and moved into project management and delivery leadership positions. He serves as an accountable executive responsible for Fortrea's liver portfolio (MASH, PSC, PBC), as well as several other metabolic and cardiovascular indications. Michiel has provided oversight across a portfolio of five T2DM studies from start-up through regulatory filing and marketing approval.
The Fortrea team consistently shows exceptional performance on our trial. Their professional commitment to meeting milestones and deliverables is truly unparalleled. The high standards they have in trial execution are unmatched and have significantly contributed to the success of the program.
Biotech
The high standards they have in trial execution are unmatched
Get the latest updates from our team
Achieving diversity in drug development programs for obesity
Diversity action plans
Download White Paper
Anti-obesity drug development: advances, challenges and mitigations to maximize success
Advances, challenges and mitigation to maximize success
Download White Paper