Building on a previous successful collaboration in early phase obesity studies with this leading multinational pharmaceutical company, ICON was once again selected as a partner to conduct a phase 1 study in individuals who are overweight or have obesity, evaluating the safety and tolerability of a new subcutaneous GLP-1 and amylin peptide formulation.

This study included 125 participants over five parts with double-blinded cohorts with single-ascending dose (SAD) and multiple ascending dose (MAD) schedules. From first patient first visit (FPFV) to last patient last visit (LPLV), the study completed in 14 months despite the added challenge of completing four additional database locks (five total) at the sponsor’s request. 

The sponsor had condensed timelines due to internal milestones and external market pressure, which emphasised the need to deliver the study quickly. In addition to finding overweight or obese volunteers that were otherwise healthy, the study criteria excluded participants with any previous amycretin exposure – essentially requiring all new volunteer recruitment. The study had five parts with multiple cohorts and long dosing groups ranging from 20 to 36-week regimens, placing additional time pressure on both enrolment and delivery. The weekly subcutaneous injection regimen required both on-site and at-home components for the volunteers.

Operationally, ICON worked within the sponsor’s desired workflows, using their standardised case report forms (CRF) and building our database around their pages. Working within sponsor data flow plans and harmonising with the sponsor data management teams added layers of complexity that, if not proactively managed, could lead to delays or miscommunications. The sponsor also added a new requirement for the Principal Investigator (PI) to sign the case books, which necessitated a shift in the original data management plan—from a single database lock to five separate locks. This change introduced both soft and hard locks throughout the trial, all of which had to be executed without disrupting ongoing operations. Notably, several of these locks occurred during the resource-constrained holiday season (November to December), adding to the complexity.

ICON’s access to healthy overweight and obese populations enhanced the recruitment process despite the challenge of the exclusion criteria. Our significant experience running clinical pharmacology and early proof of concept trials for multiple GLP-1 and other mechanisms of action enabled operational efficiencies from design to execution and patient support. The protocol and study design enabled us to run groups in parallel to complete the trial faster and improve the sponsor’s speed to market. 

We applied proven best practices to proactively manage adverse events, volunteer expectations around visits and dose escalations, and provide custom participant support and education to improve the participant journey and increase retention rates. 

To meet the challenging management and data requirements, ICON had a dedicated Data Management partnership liaison with the sponsor’s DM team that met regularly to maintain clarity and transparency and expedite solutions. The condensed timeline for the added data cleaning and database clocks meant that the locks overlapped and split resources. ICON’s proactive, agile management approach ensured the successful delivery of all five locks. 

ICON successfully limited variability for this study by applying consistent operational standards and preparing participants for adherence. As a result, this study successfully explored the potential benefits of combining different modes of action to obtain more efficacious therapeutic treatment options for overweight and obesity while avoiding pill burden.

The sponsor benefited from increased control and oversight as ICON worked within their preferred standards and dataflows while delivering additional rounds of database locks and data cleaning to meet their evolving needs.