Novo CagriSema
CagriSema is an investigational medication being developed by Novo Nordisk for the treatment of obesity and type 2 diabetes. It is a fixed-dose combination of two drugs:
Cagrilintide: An amylin analog that helps regulate appetite and reduce food intake
Semaglutide: A glucagon-like peptide-1 (GLP-1) receptor agonist that improves blood sugar control and promotes weight loss.
CagriSema is designed to work by targeting multiple pathways involved in appetite, metabolism, and weight management. Preclinical and early clinical studies have shown promising results, with participants experiencing significant weight loss and improvements in blood sugar levels.
However, it is important to note that CagriSema is still in the development phase and has not yet been approved by regulatory authorities. Further research is needed to confirm its safety and efficacy.
🧠 Oral Presentations / Late-Breaking Trials
Efficacy and Safety of CagriSema 2.4 mg/2.4 mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 Clinical Trials
⏰ Date & Time: Sunday, June 22, 12:30–13:30 p.m. CDT
🏥 Presenter(s): Donna H. Ryan, Thomas A. Lutz, Julio Rosenstock, W. Tim Garvey, Melanie Davies, Sue Pedersen & Louis J. Aronne (multi-center team, Novo Nordisk-led)
📊 Poster Presentations (Sunday–Monday, 12:30–13:30 p.m. CDT)
1978-LB – Efficacy and Safety of Semaglutide 7.2 mg in Obesity and Type 2 Diabetes: STEP UP T2D Trial
Presenter: Ildiko Lingvay et al. (UT Southwestern & Novo Nordisk collaboration)
1966-LB – Efficacy and Safety of Semaglutide 7.2 mg in Obesity: STEP UP Trial
Presenter: Sean Wharton et al.
1969-LB – Effect of CagriSema on Energy Intake, Gastric Emptying, and Appetite
Presenter: Nikolaj Bak, Rachel Ga Yeon Lee, Søren Snitker et al.
Amycretin, a Novel, Unimolecular GLP‑1 and Amylin Receptor Agonist: Results of a Phase 1b/2a Clinical Trial
Presenter: Kirsten Dahl, Kasper Adelborg, Sohan Dey, Ruben Duque do Vale, Cassandra Key, Søren Toubro & Ania Jastreboff
1733-P – Two‑Year Real-World Effectiveness of Semaglutide in Patients with Obesity or Overweight
Presenter: Aleksandrina Ruseva, Wojciech Michalak, Anthony Fabricatore et al.
1734-P – Reduction of the 10-Year ASCVD Risk in Patients Treated with Semaglutide 2.4 mg
Presenter: Thomas Kronborg, Stine Hangaard, Niels Hartvig, Anne Kaas, Nikoline Knudsen & Peter Vestergaard
💡 Key Highlights
STEP UP trials (using semaglutide 7.2 mg) are delivering top-line Phase 3 results for both obesity and combined obesity and type 2 diabetes—expected to be among Novo’s most high-profile ADA data.
CagriSema (semaglutide + cagrilintide combo) data from REDEFINE 1 & 2 mark the first phase 3 disclosure of this GLP‑1 + amylin combo, possibly positioning it as a strong follow-on to Wegovy.
Amycretin (oral and injectable GLP‑1 + amylin dual agonist) Phase 1b/2a data confirm strong weight-loss potential (22% over 36 weeks in injectables; ~13% in oral delivery)—a pivotal readout that may drive a Phase 3 initiation in Q1 2026.
Real-world poster data like 1733-P and 1734-P will highlight cardiovascular benefits and weight-loss outcomes of semaglutide 2.4 mg in routine care settings.
🧭 Context & Strategic Implications
Novo Nordisk is showcasing its “next-gen” obesity strategy at ADA:
Dose escalation of Wegovy (7.2 mg) via STEP UP studies.
The first amylin + GLP‑1 combo results from CagriSema Phase 3.
Amycretin as an innovative oral-injectable dual agonist moving toward Phase 3.
These align with their broader pipeline goals and efforts to regain momentum after CagriSema’s underperformance.