Diabetes and Endocrinology Clinical Research Expertise
Metabolic clinical development experience
Bringing drugs to market for metabolic disorders — including diabetes, obesity and related diseases — comes with a unique set of challenges. As prevalence of these diseases grows, patients worldwide are left to manage significant health issues. Without advancements in treatments for these diseases and related comorbidities, both patients and health care systems face a substantial burden. To accelerate much-needed metabolic drug development, sponsors turn to the PPD™ clinical research business of Thermo Fisher Scientific.
Our experience and expertise in planning, advancing and delivering Phase I-IV metabolic clinical trials across a broad range of drug classes enables drug developers to overcome challenges and bring much-needed treatments to affected patients.
Our deep expertise spans the full spectrum of metabolic and endocrine diseases including:
- Cardiovascular disease
- Chronic and diabetic kidney disease (CKD and DKD)
- Diabetes (Type 1 and Type 2)
- Heart failure
- Hypercholesterolemia and hypertriglyceridemia
- Inborn errors of metabolism (IEM)
- Metabolic dysfunction-associated steatohepatitis (MASH)
- Metabolic dysfunction-associated steatotic liver disease (MASLD)
- Obesity
Novel targeted approaches, including cell and gene therapies, are emerging as treatment paradigms change for metabolic disorders. To enable sponsors to successfully navigate this evolving landscape, we offer end-to-end clinical trial solutions across indications that incorporate strategies for clinical development, patient recruitment and retention, site engagement, project management, and regulatory strategies.
By partnering with an experienced provider of clinical research solutions for metabolic and clinical trials, you are better positioned to drive your treatments forward and meet key milestones, faster.
Unlocking success in metabolic clinical trials
In the past five years, drug developers have turned to our clinical research team — which includes dedicated adult and pediatric endocrinologists and internist medical and operational experts — for our metabolic disease expertise, global footprint, site network and patient-centric solutions that move drug development programs forward efficiently and at the highest level of quality.
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Cardiovascular Kidney Metabolic Center
New drugs with innovative mechanisms of action have proven effective in treating cardiovascular, renal and metabolic conditions. That’s why we’ve created the Cardiovascular Kidney Metabolic (CKM) Center to explore how the links between different organ systems can advance drug development for these indications. Our CKM Center brings together a diversified group of experts to address all nuances of clinical development across the spectrum of metabolic diseases and their comorbidities.
Digital implementation
Successful diabetes clinical trials require a deep understanding of how to manage and overcome the complexities inherent to these studies. Our physicians and operations teams collaborate with sponsors to identify and implement strategies, from traditional to novel approaches, to achieve study goals with efficiency.
We offer solutions that make it easier for patients to stay on track, like an eDiary that integrates with multiple devices or the creation of lifestyle coaching plans that are age appropriate and culturally aligned. Patients also benefit from our approach to capturing body composition and vital sign data points, to capture a fuller picture and emphasize more than their weight.
Continuous glucose monitoring (CGM) has transformed the landscape for diabetes treatment options. Our leading-edge CGM technology is among a handful of solutions that are compliant with 21 CFR part 11. Coupled with our interactive Spotfire dashboard, GCM and other real-time data can be reviewed concurrently — simplifying data analysis and trend identification and enabling proactive mitigation of safety concerns.
GLP-1 experience
The market for glucagon-like peptide 1 (GLP-1) agonist drugs is expanding beyond Type 2 diabetes into new therapy areas and is forecasted to reach $150 billion by 2030. In response to this growth, sponsors are seeking the support of an experienced contract research organization (CRO) to bolster their development of these in-demand treatments.
With more than 25 years of experience advancing the development of GLP-1 drugs, we know what it takes to overcome the medical and operational challenges associated with these studies. Sponsors developing GLP-1s leverage our expertise in:
- Accessing treatment-naïve patients
- Recruiting patients in a competitive trial landscape
- Retaining patients, even in the face of GI side effects
- Justifying placebo comparators
- Navigating long-term safety data
- Providing centralized dietitians to develop age and culturally aligned diet and exercise plans and lifestyle considerations
In addition to treating Type 2 diabetes, drug developers are putting our experience into action, with Phase I–IV clinical trials for GLP-1 drugs targeting:
- Cardiovascular disease
- Diabetic kidney disease (DKD)
- Diabetic retinopathy
- Obesity
- Type 1 diabetes
Hear from our experts about expanding GLP-1 therapies beyond Type 2 diabetes
Obesity expertise
As the prevalence of obesity rises, the number of drug developers exploring weight management therapies is increasing. As a strong CRO partner, we improve sponsors’ likelihood of success in obesity trials. Our expertise includes:
- 16 obesity studies in the past five years
- 8,500+ patients enrolled in obesity studies
- 7 in-house endocrinologists
- Pediatric obesity and diabetes experience
- Global network of PPD™ Laboratory services central labs
Challenges in treating obesity are compounded by massive amounts of misinformation about nutrition. Through our significant experience conducting obesity studies, our patient-centric strategies involve the implementation of a standardized nutritional and lifestyle program managed by an in-house dietitian. The enables each patient in the study to have the same nutrition information, bringing increased accuracy to assessing the impact of the therapy under investigation.
Sponsors also tap into our experience with GLP-1-based therapies to explore using these groundbreaking treatments in obesity trials.
Identifying the right patients for your metabolic studies
A highly competitive clinical trial landscape makes enrolling and retaining the right patients for metabolic clinical trials a challenge. Biopharma and biotech organizations benefit from our comprehensive patient recruitment strategy, which leverages advanced data modeling tools, real-time recruitment techniques and our robust, proprietary patient database that includes more than 12 million self-reported diabetes patients. These resources — paired with our partnerships with Accelerated Enrollment Solutions and Science 37 — enable us to predict study enrollment rates, identify diverse patient populations and enroll patients at two times faster than industry average.
Sponsors also benefit from our approach to recruiting diverse and representative patient populations, aligning with diversity plan guidance from the U.S. Food and Drug Administration (FDA). Our patient diversity strategies span trial design and startup, with broad and demographically appropriate inclusion/exclusion criteria; enrollment and retention, which includes the development of culturally competent and inclusive patient-facing recruitment; study materials; and patient advocacy and community engagement, which enables patients to learn of study opportunities through trusted sources and patient advocacy groups.
Beyond patient recruitment, we also work with sites and sponsors to ensure they are retained. Collaborations with patient advocacy groups provide details for what’s most important to the patient, and relationships with vendors provide valuable prescription insights. Our patient concierge service designates a single point of contact for patients, helping them navigate the trial process and offering personalized logistical and technological support.
Patients also benefit from our centralized lifestyle intervention plan, which provides study participants with the motivation and support to achieve long-term lifestyle changes that promote health improvements. This type of encouragement has been shown to aid in patient retention.
Digital and decentralized solutions
Employing digital and decentralized trial elements helps bring clinical research to the patient, enhancing patient-centricity by simplifying participation and increasing site efficiency through the use of:
- CGM cloud downloads
- eConsent
- eDiary
- Home health services
- Mobile sites
- Patient dashboards
- Remote monitoring
- Wearables
Cell and gene therapy
Drug developers are exploring the use of cell and gene therapies (CGT) to treat serious genetic metabolic conditions, including Type 1 diabetes. In collaboration with our Cell and Gene Therapy Institute and pediatric medical experts, we enable sponsors to navigate the complex regulatory, operational, logistic and lab testing landscape of advanced therapies for metabolic conditions.
Advance your treatment with our cell and gene therapy solutions
PPD Laboratory services for metabolic clinical trials
Our PPD Laboratory services central lab services supports metabolic studies through:
- Testing validation services performed in 12 weeks
- A full complement of routine safety testing
- In-house analysis of metabolic-specific biomarkers
- Management and onward shipping to referral labs of biomarker samples
Beyond testing, our Preclarus™ centralized data repositories and workspace support collaborative trial designs and operations, leveraging an adaptive approach to risk-based monitoring.
Explore the full scope of the PPD Laboratory services central lab
Additional resources
Drive your metabolic development program forward
Our teams know how to deliver mission-critical solutions for metabolic and endocrine disorders. Let’s work together to assess your program’s goals and accelerate your success.