Incretin-Based Treatment for Obesity

(HARMONY Trial)

This trial aims to determine if combining a lifestyle program with medication helps people with obesity maintain muscle and physical function better than medication alone. The study includes one group taking only medication and another group receiving medication plus exercise and nutrition support. It seeks adults with obesity who have been prescribed an incretin-based medication (a drug that helps regulate insulin and appetite) but have not yet started it. Participants will be assigned to either group, and researchers will monitor their progress over a year. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve obesity treatment strategies.

The trial information does not specify if you need to stop taking your current medications. However, you must not have started incretin-based therapy before joining the study.

Research has shown that incretin-based therapies, often used for weight loss, are usually well-tolerated by people with obesity. Clinical trials have found that these treatments can lead to significant weight loss, with some studies showing a reduction of 15-20% in body weight.

However, some individuals may experience side effects, mostly related to the stomach and intestines, such as nausea or diarrhea. These side effects can vary depending on the specific medication, but they are often mild and temporary. Newer incretin-based treatments, like liraglutide and semaglutide, generally cause fewer side effects than older ones.

Researchers are excited about incretin-based treatments for obesity because they target hormones that help regulate appetite and blood sugar, offering a fresh approach compared to standard options like diet, exercise, and medications that primarily focus on calorie restriction or fat absorption. Unlike these traditional methods, incretin therapies may enhance the body's natural ability to manage hunger and maintain healthier blood sugar levels. Additionally, combining this treatment with a structured lifestyle intervention, including exercise and diet consultations, might amplify its effectiveness and provide a more comprehensive solution for weight management.

Research has shown that incretin-based therapies can aid in weight loss. In several studies, more than half of the participants using these treatments lost at least 5% of their body weight. Other research found that adults with obesity and type 2 diabetes lost 15.7% of their weight over 72 weeks. These treatments can also reduce calorie intake by 16% to 39%. Newer incretin-based medications, such as liraglutide and semaglutide, prove more effective than older weight loss drugs. In this trial, participants will receive either incretin-based pharmacotherapy alone or in combination with a 6-month lifestyle intervention. These findings suggest that incretin-based therapies can significantly aid weight loss in people with obesity.¹³⁴⁵⁶