Due to the rising global prevalence of diabetes, particularly Type 2, diabetes research has seen a significant increase in funding, investment, and resource allocation in recent years. Such investment has led to a number of milestone approvals, notably including those for GLP-1 receptor agonists.
Glucagon-like peptide-1 (GLP-1) agonists are a novel class of medication which works by mimicking the action of the glucagon-like peptide 1 hormone within the body. GLP-1 agonists stimulate insulin secretion, lowering serum glucose levels, and therefore manage metabolism and reduce appetite in patients using the medication. Although initially developed for the treatment of patients with Type 2 Diabetes, these agents have demonstrated substantial benefit in the management of obesity.
Clinical trials are continuing to evaluate the efficacy of GLP-1 for use in obesity. STEP confirmed a sustained and clinically relevant reduction in body weight for obese patients taking semaglutide within a double-blind trial. SURMOUNT also found substantial and sustained reductions in body weight for patients taking tirzepatide across a 72-week phase 3 double-blind, randomized, controlled trial. Another multicenter, double-blind, randomized, placebo-controlled, event-driven superiority trial of 17,604 patients found that in patients with preexisting cardiovascular disease and obesity (without diabetes), semaglutide administration reduced the incidence of death from cardiovascular causes, nonfatal myocardial infarction, and nonfatal stroke.
Such research has resulted in FDA approvals, including the approval of semaglutide in 2021 for chronic weight management in adults with obesity with at least one weight-related condition, and the approval of tirzepatide in 2023 for chronic weight management.
GLP-1 agonists are now a firm pharmacological option for the treatment and management of obesity, with much research focusing on evaluating the risk of use versus the weight-loss benefit of metabolic improvement and reduced co-morbidity risk. Such approvals have resulted in a notable increase in obesity treatment trials, and as with any new medication to market, this requires substantial planning, evaluation, and comprehensive clinical trial adjudication.
Clinical adjudication in obesity trials
Independent clinical adjudication of efficacy and safety endpoints in obesity trials is essential to fully understand the potential benefits and risks of treatment beyond the loss of weight. Accurate assessment of efficacy endpoints, such as weight loss and body composition, must be considered against any increase in risk, including cardiovascular or gastrointestinal events. Clinical adjudication ensures such endpoints are evaluated objectively, minimizing trial outcome variability, and ensuring reliable and trustworthy data for regulatory submission.
Clinical adjudication within obesity trials, however, comes with a set of unique challenges. Obesity is a multisystem disease associated with a wide spectrum of comorbidities, meaning events requiring adjudication often span multiple different therapeutic areas within a single trial. Clinical adjudication events can often involve the cardiovascular, endocrine, hepatic, and renal systems, to name but a few. This multi-system involvement makes the coordination of a global clinical event committee (CEC) particularly demanding and complex, requiring operational excellence and a diverse therapeutic infrastructure of expert KOLs and clinical experts from the outset.
Perceptive’s operational support
Perceptive delivers standardized and objective event adjudication evaluations across different regions and clinical practices for obesity research. Perceptive’s clinical adjudication team has a combined 60 years of experience managing and supporting clinical event adjudication services, including extensive work on several obesity trials. Through this experience, we have established robust, regulatory-compliant, and efficient processes which mitigate the challenges associated with adjudicating efficacy and safety endpoints in obesity and weight loss trials.
- 60+ years of combined adjudication experience
- 600K+ clinical events adjudicated
- Global network of 250+ Key Opinion Leaders (KOLs) and clinical experts
- Event identification and tracking
- Source data collection and tracking
- Charter development
- Adjudication form development
- Clinical event committee compilation
- Adjudication process coordination and management
Perceptive is uniquely positioned to provide clinical adjudication services for your obesity and weight loss clinical trials.
Learn more about Perceptive Imaging Services today or contact an imaging solutions specialist.
To view our infographic: https://www.perceptive.com/wp-content/uploads/2024/09/Perceptive_Adjudication-in-Obesity-Trials_v1.625_Final.pdf
Resources
WHO. Diabetes. https://www.who.int/news-room/fact-sheets/detail/diabetes
https://www.ncbi.nlm.nih.gov/books/NBK551568/
The New England Journal of Medicine. Once-Weekly Semaglutide in Adults with Overweight or Obesity. https://www.nejm.org/doi/full/10.1056/NEJMoa2032183
The New England Journal of Medicine. Tirzepatide Once Weekly for the Treatment of Obesity. https://www.nejm.org/doi/full/10.1056/NEJMoa2206038
The New England Journal of Medicine. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. https://www.nejm.org/doi/full/10.1056/NEJMoa2307563