Metabolic Disease CRO Services

Obesity and GLP-1 are at the heart of what we do, with metabolic delivery experience spanning Phase I through Phase IV. Our metabolic team covers the full indication range, from GLP-1 RA dose finding and chronic weight management through T2D combination therapy, metabolic syndrome, and rare metabolic disease. T1D, T2D, and metabolic syndrome are covered through dedicated sub-page content, and our rare metabolic reach spans hypothalamic obesity, Bardet-Biedl syndrome, Prader-Willi syndrome, familial hypercholesterolemia, lysosomal storage disorders, and inborn errors of metabolism.

The post-GLP-1 patient population is genuinely different from what it was a few years ago, and our site selection model reflects that. We select obesity sites specifically for longitudinal weight-management patient visibility, meaning sites maintain patient databases that track GLP-1 exposure history, plateau effects, and eligibility trajectories over time rather than relying on transactional patient recruitment. Prescreening campaigns are designed around post-GLP-1 exposure dynamics, and eligibility criteria are built to capture the right populations at the right stage of their weight management journey. Patient education covers GLP-1 GI side effects, nutritional guidance, and reimbursement strategies tailored to these therapies, and obesity bias training and patient journey mapping are built into site engagement from selection forward.

Our governance model is built around direct senior engagement rather than multi-layer approval processes. Franchise scientific leaders, senior project managers, and medical monitors are on the program from kickoff, which means protocol amendments and interim analysis pivots are resolved at the team level in days rather than escalated through governance layers. Real-time centralized data review runs throughout the program so the team never waits on data to make decisions. A recent Phase IIa GLP-1 RA program enrolled 40% faster than planned, a Phase II T2D program completed feasibility in two weeks with CIRB-to-activation in two months, and an Obesity and Metabolic Syndrome Phase II randomized 243 patients two months early with 80% retention through completion.

Large-scale CVOTs in metabolic populations require a site network with depth and breadth, data management infrastructure built for high volume, and proactive monitoring that keeps dropout rates low across long recruitment windows. Our Phase IV CVOT in the obesity and overweight cardiovascular-risk population ran across 473 sites in 8 countries, brought in 12,000 patients across 22 months of recruitment, adjudicated 1,758 events, and finished with under 2% lost to follow-up. That retention rate came from proactive site engagement, patient journey mapping built into the program from the start, and a monitoring model that averaged 170 site visits per month across more than 10,000 total monitoring visits. Database lock was delivered on time.

Site selection for obesity and GLP-1 programs starts with feasibility intelligence rather than transactional clinic databases. We use patient density data and longitudinal weight-management records to identify sites where the right patient populations actually exist, then evaluate each site against criteria including GLP-1 experience, DEXA access, obesity bias training, diversity coverage, flexible scheduling, and a proven enrollment record. The Global Obesity Site Alliance spans 615 dedicated sites across North America (360), Europe (170), LATAM (45), and APAC (40), pre-qualified through this process, inside a broader network of 2,020 experienced metabolic sites across the U.S. and Canada. Alliance sites move faster on activation and stronger on enrollment because the relationships and qualification work are already done.

Rare metabolic programs require a different operational approach from large-scale metabolic trials. We build feasibility around documented disease prevalence, engage KOLs and patient advocacy groups early to support site identification and patient awareness, and design adaptive protocols specifically for small patient populations. For hypothalamic obesity, we delivered a Phase III global program across 8 countries and 33 sites with 182 patients enrolled. We also delivered a lifestyle modification Phase IV program for obese children and adolescents across 20 sites with 260 patients enrolled. Our broader rare metabolic reach spans Prader-Willi syndrome, Bardet-Biedl syndrome, Fabry, Niemann-Pick, lysosomal storage, PKU, MPS VII, tyrosinemia, X-linked hypophosphatemia, and additional rare endocrine indications. For T2D programs extending into cardiovascular-kidney-metabolic syndrome, our cross-franchise scientific leaders bring integrated CKM expertise spanning metabolic, cardiovascular, and renal biology.

Cross-franchise programs succeed when the scientific leaders from each franchise are working together from protocol design rather than being handed off sequentially. At Worldwide, our metabolic, cardiovascular, and liver franchise scientific leaders sit in one business unit, which means obesity-into-MASH, obesity-into-T2D, and GLP-1 combination programs get integrated input on protocol design, endpoint strategy, and patient population targeting from day one. For cardiometabolic outcomes programs specifically, the same team that designed the protocol is running the CVOT, with access to our preferred vendor relationships across CGM, body composition, and central metabolic labs throughout. Worldwide’s digital biomarker infrastructure, including partnerships with Clinical Ink and AMRA, supports real-time data integrity and high-resolution metabolic endpoints across these cross-franchise programs.

Emerging biotech obesity sponsors need a CRO that compensates for a lean internal team, moves at the speed their funding demands, and delivers data that is clean and acquisition-ready. Every element of how we work is designed around those pressures. Senior scientific leaders and project managers are on the program from the first protocol conversation, not brought in after kickoff. The site infrastructure for obesity and GLP-1 programs is already in place through the Global Obesity Site Alliance, so activation moves faster than it would with a cold network. Governance is structured for rapid decision-making, with interim analysis pivots resolved in days rather than weeks. The team that wins the study delivers it, with the same leadership intact through database lock. And our repeat-business track record with sponsors who came back for Phase III reflects what that continuity actually produces.