Early Phase Obesity Trials

ICON has proven success designing, managing, and executing early phase obesity studies. With a robust database of overweight/obese volunteers across our clinical research units we can rapidly meet key eligibility criteria and study milestone timelines.

35+ studies
Successfully achieved or exceeded enrolment targets over the past 5 years
95%
Retention rate, even for long duration trials with multiple overnights and lengthy follow-up periods

Delivering benefits to your obesity study:

Skilled investigators: Highly experienced team who have successfully managed early phase obesity trials across most mechanisms of action currently in clinical development.

Access to healthy obese subjects: Successful track record recruiting, enrolling and retaining large numbers of obese subjects who are otherwise healthy for early phase trials.

Scientific knowledge: Significant experience in managing PD endpoints and biomarkers for obesity assets.

Consistency of results: A network of ICON owned phase 1 clinics with proven ability to demonstrate bioequivalence of various injection devices through training and consistency across multiple sites.

Obesity trial experience: Significant experience running clinical pharmacology and early proof of concept trials for multiple GLP-1 and other mechanisms of action (MOAs) that have received FDA approval or are in clinical development.

Early phase services tailored to obesity trial requirements:

Access to obese and overweight subjects

Early phase obesity studies have some unique volunteer requirements. They require obese and overweight subjects who are otherwise healthy and are willing to meet the restrictions of early phase trials which contain both regular visits and overnight confinements. ICON’s Phase I clinics have successfully achieved or exceeded enrolment targets across more than 35 early clinical studies with obesity assets over the past five years.

Best practice approaches for dealing with adverse event profiles

Many investigational and approved obesity treatments have unique adverse event profiles including known gastrointestinal effects. ICON’s investigators have significant experiencing working on early clinical trials with these products including GLP-1s, dual and triple receptor agonists, and other novel mechanisms of action. This experience has helped us to develop best practice approaches for successful titration, the proactive management of adverse events, successful protocol design around escalation and other critical aspects resulting in a successful study with strong retention and adverse event management.

Consistent operational standards

The route of administration for most obesity studies requires subcutaneous injection, with different injectable devices often compared for equivalence. In these studies, the consistency in delivery technique across multiple clinics is very critical, particularly if the study is evaluating the safety, tolerability and bioequivalence of PK across multiple types of injector devices. ICON has successfully limited variability for these studies in applying consistent operation standards/techniques and training across multiple sites to successfully prove bioequivalence of injection devices.