Our team has conducted dozens of cardiometabolic studies in healthy volunteer and patient populations. Experience spanning SAD/MAD studies, Phase Ib and proof-of-concept (PoC) trials.
Trials conducted in overweight and obese populations
8,000+
Prescreened volunteers in database, BMI 27.0 – 35.0
0
Beds with 8 private suites for overnight confinement
Indications and populations
Obesity is a chronic disease that raises the risk of other conditions, including diabetes and heart disease, and it now affects more than two in five adults in the U.S. We conduct early phase studies in overweight and obese volunteers, and maintain a prescreened database organized by BMI so enrollment starts from a known, ready population.
Population
BMI range
Prescreened volunteers (2025)
Overweight to obese
27.0–35.0 kg/m²
8,000+
Obese
30.0–40.0 kg/m²
5,000+
Obese to severely obese
30.0–45.0 kg/m²
5,000+
Obesity assessments
Our experience in this area spans from single and multiple ascending dose studies, combined Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD) designs and patient cohorts, to New Drug Application (NDA)-enabling clinical pharmacology studies and Phase Ib/IIa proof-of-concept work.
A distinct challenge in obesity trials is that many overweight and obese volunteers have never taken part in clinical research because of their BMI. The high level of customer service in our clinical pharmacology unit is central to recruiting and retaining these volunteers, which ensures enrollment timelines.
Cardiometabolic & obesity infrastructure and partnerships
Clinical pharmacology unit
Our physician-led clinical pharmacology unit supports cardiometabolic & obesity studies requiring inpatient stays, intensive PK sampling, continuous safety monitoring and complex multi-period designs, so studies with demanding monitoring or dosing requirements can be executed in a controlled environment. The unit accommodates both healthy volunteer and patient cohorts.
Multicenter trials
For multicenter patient trials, we draw on an established network of strategic site partners with documented experience enrolling overweight and obese populations. Site selection and ongoing oversight are managed by our Site Partnerships Team, with criteria aligned to investigator experience, enrollment performance and data quality standards, helping sponsors achieve consistent execution across participating sites.
Through our Lead Site Model, we can serve as both the CRO and the first enrolling clinical research unit, providing firsthand operational insight that helps strengthen protocol compliance, improve feasibility and identify potential challenges before they impact study conduct. This approach supports faster site readiness, streamlined communication between sponsors and sites and delivers consistent execution across the study lifecycle.
Central lab
Our Central Laboratory supports multicenter studies with laboratory manual development, kit production, site supply logistics and standardized specimen management. Centralized laboratory data and real-time access to results help improve data consistency across sites, supports safety oversight and streamlines study execution from startup through final reporting.
PK processing & safety laboratory
Our CLIA-certified PK Processing & Safety Laboratory provides on-site safety testing, endpoint sample processing and real-time access to laboratory results. Integrated technology and barcode-enabled workflows support efficient study execution, data quality and timely study decisions.
Pharmacy services
Study drug is prepared and stored on-site in our 2,500 sq. ft. cGMP-compliant pharmacy, which is DEA-registered to handle and store Schedule I-V controlled substances. The pharmacy is equipped to prepare investigational products across multiple routes of administration, including injectable formulations, nasal insufflation, powder-in-capsule, powder-in-solution and over-encapsulation. Integration within our Phase I unit enables rapid delivery of prepared doses under controlled conditions, reducing the number of handoffs, maintaining chain of custody and delivering on-time dosing.
Technology and data visibility
Our fully integrated technology platform, including eSource, EDC and CTMS, along with AI-driven tools help streamline data collection throughout the study. These secure, cloud-based systems provide real-time data visibility, validated audit trails, data integration and scalable access to reliable, high-quality data across the entire study lifecycle.
Our cardiometabolic & obesity leadership
Our Cardiometabolic & Obesity team brings together experienced clinical research, operational and study management professionals dedicated to the successful execution of cardiometabolic and obesity trials. Our team is led by William Lavery PhD, a board-certified physician in obesity medicine. His expertise helps guide protocol development, study strategy and execution. Our clinical team has been involved in the conduct of dozens of studies in obese populations.
Talk to a team that has extensive experience in overweight and obese populations.
We will discuss your protocol and timeline and how our recruitment capabilities supports a predictable execution path. Our team helps position your study for efficient execution from startup through completion.
