Novo Nordisk is planning a study that will see CagriSema, a new investigational medicine developed by Novo that combines Cagrilintide and Semaglutide, compared to Tirzepatide for weight loss. The ‘Efficacy and Safety of Cagrilintide 2.4mg s.c. in Combination With Semaglutide 2.4mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15mg s.c. Once-weekly in Participants With Obesity’ study will enrol 800 patients and examine their weight loss after 72 weeks of treatment. The trial will measure the number of patients in each arm who’ve achieved at least 25% or 30% weight reduction at the end of treatment. The additional secondary endpoints include changes in cholesterol levels, triglycerides and waist circumference etc.
Cagrilintide is an investigational novel long-acting acylated amylin analogue and acts as nonselective amylin receptors (AMYR) and calcitonin G protein-coupled receptor (CTR) agonist. Phase 2 data published in June showed that once-weekly CagriSema led to an average 15.6% bodyweight reduction at week 32 among type 2 diabetes patients living with overweight or obesity.
By comparison, people on cagrilintide alone achieved an average 8.1% loss, while Wegovy hit a 5.1% decrease. The study was small with only 92 participants. This study is expected to be completed in October 2025.
This is the second head-to-head study after Eli Lilly registered its intent to carry out a Phase 3b clinical trial in April 2023 that will see the company’s tirzepatide (Mounjaro) compared with Novo Nordisk’s semaglutide (Wegovy) 2.4mg in 700 adult participants who have obesity or overweight with weight related comorbidities without Type 2 diabetes.
The study, ‘A Study of Tirzepatide in Participants With Obesity or Overweight With Weight Related Comorbidities (SURMOUNT-5)’, has the primary outcome of percent weight change from baseline in body weight over a 72-week period. The study will have secondary measures including ≥10%, ≥15%, ≥20%, ≥25% and >30body weight reduction, change from baseline in waist circumference in cms, change from baseline in body mass index and percent change from baseline in body weight, all over a 72-week period. This study is expected to be completed in November 2024.