CagriSema for Obesity

This trial tests a new medicine called CagriSema to evaluate its effects on metabolism, the body's process of converting food into energy, compared to a diet. The study consists of two parts: some participants will start with CagriSema, while others will begin with a low-calorie diet, and eventually, all will receive CagriSema. The trial is open to individuals with a Body Mass Index (BMI) of 30 or more, typically indicating excess weight due to fat. Participants should not have diabetes, unusual eating habits, or issues with small spaces like claustrophobia. The study medicine may cause side effects, and the trial will last about 1.5 years. As a Phase 1 trial, this research aims to understand how CagriSema works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

The trial requires that you stop taking any medications prescribed for obesity or weight management, as well as metformin or other glucose-lowering agents, at least 90 days before joining the study.

Research shows that CagriSema, a combination of cagrilintide and semaglutide, has been tested in people before. In earlier studies, CagriSema showed promising results in aiding weight loss. Specifically, one study found that participants lost up to 22.7% of their body weight without major safety concerns.

The treatment is generally well-tolerated, with most people not experiencing serious side effects. CagriSema leads to more weight loss compared to similar treatments and causes fewer issues like vomiting. However, like any medicine, side effects can occur, so monitoring for any changes while taking it is important.

Researchers are excited about CagriSema for obesity because it combines two active ingredients, cagrilintide and semaglutide, which work together to help manage weight. Unlike standard treatments like phentermine or orlistat, which focus on appetite suppression or fat absorption, CagriSema offers a unique dual approach. Cagrilintide mimics a natural hormone that helps regulate appetite, while semaglutide is a GLP-1 receptor agonist that enhances insulin secretion and promotes satiety. This combination potentially offers a more effective and comprehensive method for weight management, aiming to improve results compared to existing options.

Research has shown that CagriSema, a combination of cagrilintide and semaglutide, can significantly aid weight loss. In earlier studies, adults without diabetes lost up to 22.7% of their body weight, while those with type 2 diabetes lost about 15.7%. More than 90% of participants lost at least 5% of their weight. Over half lost 20% or more, and around a third lost 25% or more. In this trial, participants will receive CagriSema either directly or after a low-energy diet intervention. These findings suggest that CagriSema could be highly effective for treating obesity.¹³⁵⁶⁷