Cagrilintide for Obesity and Type 2 Diabetes

(RENEW 2 Trial)

This trial tests a new medicine, cagrilintide, to determine if it aids weight loss in people with obesity and type 2 diabetes. Participants will receive either cagrilintide or a placebo, with a higher likelihood of receiving the actual treatment. The trial seeks individuals with a body mass index (BMI) of 27 or higher, who have had type 2 diabetes for at least six months, and have struggled to lose weight through diet. Participants will engage in the study for about a year and a half. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment that could soon become widely available.

You may need to stop certain medications if they are prescribed for weight management or are GLP-1 receptor agonists, unless you meet specific criteria. However, if you are on stable doses of certain diabetes medications, you may continue them during the trial.

Research has shown that cagrilintide is generally safe for individuals who are overweight or have obesity. In previous studies, it aided weight loss without causing serious side effects. Some participants experienced mild to moderate issues like nausea or vomiting, but these were uncommon, and most could continue the treatment. Researchers have also studied the body's handling of cagrilintide and found it safe for repeated use. Since this trial is in a late stage, substantial safety data suggests that cagrilintide is safe for most people. However, as with any treatment, reactions can vary from person to person.¹²³⁴⁵

Cagrilintide is unique because it introduces a new approach to managing obesity and Type 2 diabetes by mimicking a natural hormone involved in appetite regulation. Unlike traditional treatments that primarily focus on insulin regulation or appetite suppression through alternate pathways, cagrilintide works by targeting the amylin hormone pathway, which plays a significant role in reducing hunger and controlling food intake. Researchers are excited about cagrilintide because it is administered as a once-weekly injection, offering potential convenience and compliance benefits over daily medications. This innovative mechanism and delivery method could represent a promising advancement in the long-term management of these conditions.

Research has shown that cagrilintide can aid in weight loss. One study found that participants using only cagrilintide lost 9.7% of their body weight in 26 weeks. This trial will test cagrilintide alone, with participants receiving it subcutaneously once weekly for 64 weeks. Another study discovered that combining cagrilintide with semaglutide resulted in weight loss of up to 15.7% in individuals with type 2 diabetes. These findings suggest that cagrilintide could be a promising treatment for managing obesity and type 2 diabetes.¹⁶⁷⁸⁹