cagrilintide (AM833) / Novo Nordisk - LARVOL DELTA

A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P3 trial • Genetic Disorders • Obesity

Exploration of Cagrilintide's Mechanism of Action in the Kidney (ERA 2025) - "Tubules were exposed to a phosphodiesterase inhibitor (IBMX 0.5mM, 15 minutes) and then treated with vehicle, cagrilintide (1µM), or salmon calcitonin (1µM) for 30 minutes. Our results point to a diabetes-specific mechanism by which cagrilintide elevates cAMP in cortical tubules, providing initial evidence of mode of action in diabetic kidney physiology compared with healthy controls. Ongoing phosphoproteomic analyses will offer deeper insights into the molecular pathways affected, potentially guiding the therapeutic application of cagrilintide in diabetic kidney disease"

Chronic Kidney Disease • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Obesity

RAMBO: The Role of the Amylin Analogue Cagrilintide in Bone Metabolism (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Genetic Disorders • Obesity

Characterization of 0839 - a tool compound for pre-clinical mode-of-action studies of amylin analogues such as cagrilintide (ECO 2025) - No abstract available

Late-breaking abstract • Preclinical

Current and Emerging Parenteral and Peroral Medications for Weight Loss: A Narrative Review. (PubMed, Diseases) - "This narrative review explores established and emerging pharmacotherapies for weight management, including parenteral agents like Liraglutide, Semaglutide, Setmelanotide, and Tirzepatide, as well as peroral medications such as Phentermine, Phentermine/Topiramate, Bupropion/Naltrexone, Orlistat, and Metformin. Newer treatments like Cagrilintide and Bimagrumab show promise for enhancing weight loss outcomes...This includes exploring how AI can complement combination therapies and tailor personalized interventions, thereby grounding its potential benefits in robust clinical evidence. Future directions will focus on integrating AI into clinical trials to refine and personalize obesity management strategies."

Journal • Review • Genetic Disorders • Obesity

Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease (clinicaltrials.gov) - P2 | N=270 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology

Effect of Combined Therapy with Once-Weekly Subcutaneous Cagrilintide 2.4 mg and Semaglutide 2.4 mg (CagriSema) on Energy Intake, Gastric Emptying, and Appetite in Adults with Overweight or Obesity (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Late-breaking abstract • Metabolic Disorders • Obesity

Eloralintide (LY3841136), a Selective Amylin Mimetic, Lowered Body Weight with Improved Quality of Weight Loss and GI Tolerability in Rats Compared with Cagrilintide (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Preclinical • Metabolic Disorders

Advancing Diabetes Management and Glycemic Control While Exploring CagriSema's Impact on Obesity Management. (PubMed, Cardiol Rev) - "A new drug under investigation, CagriSema, combines cagrilintide, an amylin analog, with semaglutide, a glucagon-like peptide-1 agonist...In this article, the pathophysiology, current guidelines, and management of diabetes will be reviewed, with an emphasis on the clinical evidence for tight glucose control and avoiding hypoglycemic events. Following this, an overview of recent trials on antidiabetic medications, including those involving CagriSema, will be presented, along with prospects for future trials in this promising area of research."

Journal • Cardiovascular • Diabetes • Genetic Disorders • Hypoglycemia • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

REIMAGINE 5: A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both (clinicaltrials.gov) - P3 | N=1023 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Novo Nordisk A/S | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Comparative Effectiveness of Semaglutide, Liraglutide, Orlistat, and Phentermine for Weight Loss in Obese Individuals: A Systematic Review. (PubMed, Cureus) - "This literature review evaluates and compares the effectiveness of four pharmacological agents semaglutide, liraglutide, orlistat, phentermine, and emerging agents like setmelanotide, amycretin, retatrutide, cagrilintide, and cotadutide in managing weight loss among obese. A detailed analysis was conducted on their mechanisms of action, dosing regimens, efficacy in weight loss, safety profiles, and their impact on obesity-related comorbidities. Although all agents presented distinct benefits, side effects such as gastrointestinal discomfort with orlistat and GLP-1 receptor agonists, and potential dependency with phentermine, necessitate tailored treatment approaches. This review highlights the importance of integrating pharmacotherapy with lifestyle interventions to achieve sustainable weight management and identifies areas for future research to optimize therapeutic outcomes for individuals with obesity."

HEOR • Journal • Review • Cardiovascular • Gastrointestinal Disorder • Genetic Disorders • Obesity

A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo (clinicaltrials.gov) - P2 | N=618 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Diabetes • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus • CST3

Structural and dynamic features of cagrilintide binding to calcitonin and amylin receptors. (PubMed, Nat Commun) - "Here, we determine structures of cagrilintide bound to Gs-coupled, active, amylin receptors (AMY1R, AMY2R, AMY3R) and calcitonin receptor (CTR) and compare cagrilintide interactions and the dynamics of receptor complexes with previously reported structures of receptors bound to rat amylin, salmon calcitonin or recently developed amylin-based peptides. These data reveal that cagrilintide has an amylin-like binding mode but, compared to other peptides, induces distinct conformational dynamics at calcitonin-family receptors that could contribute to its clinical efficacy."

Journal • Genetic Disorders • Metabolic Disorders • Obesity

Incretin-based therapies for the treatment of obesity-related diseases (ATTD 2025) - "Liraglutide, semaglutide and tirzepatide are incretin-based therapies currently approved by FDA for the management of obesity, while triple GIPR/GCGR/GLP-1R agonist retatrutide (LY3437943), the cagrilintide/semaglutide (CagriSema) 2.4 mg combination, high-dose oral semaglutide, and oral orforglipron are in advanced stages of development...Liraglutide, semaglutide and tirzepatide are incretin-based therapies currently approved by FDA for the management of obesity, while triple GIPR/GCGR/GLP-1R agonist retatrutide (LY3437943), the cagrilintide/semaglutide (CagriSema) 2.4 mg combination, high-dose oral semaglutide, and oral orforglipron are in advanced stages of development...Moreover, incretin-based therapies have also been proven beneficial on obesity-related comorbidities, such as knee osteoarthritis (KOA), obstructive sleep apnea (OSA) syndrome, and MASLD. Further research is needed to improve our understanding of their effects on obesity-related comorbidities and the..."

Cardiovascular • Congestive Heart Failure • Diabetes • Genetic Disorders • Heart Failure • Hepatology • Immunology • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Obstructive Sleep Apnea • Osteoarthritis • Pain • Respiratory Diseases • Rheumatology • Sleep Disorder • Type 2 Diabetes Mellitus

Research Study on Whether a Combination of 2 Medicines (NNC0194 0499 and Semaglutide) Works in People With Non-alcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=698 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities. (PubMed, Peptides) - "Recent studies with peptide-based incretin herapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP)...New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The..."

Journal • Cardiovascular • Diabetes • Genetic Disorders • Hepatology • Inflammation • Metabolic Disorders • Nephrology • Obesity • Obstructive Sleep Apnea • Orthopedics • Renal Disease • Respiratory Diseases • Sleep Apnea • Sleep Disorder • Type 2 Diabetes Mellitus

REDEFINE 2: A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight (clinicaltrials.gov) - P3 | N=1200 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight (clinicaltrials.gov) - P3 | N=331 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity • Type 2 Diabetes Mellitus

The promise of glucagon-like peptide 1 receptor agonists (GLP-1RA) for the treatment of obesity: a look at phase 2 and 3 pipelines. (PubMed, Expert Opin Investig Drugs) - "Liraglutide 3.0 mg daily, the first GLP-1 RA approved for treatment of overweight, induced a weight loss of 6-8%, Semaglutide 2.4 mg once weekly improved weight loss to about 12-15%, while the dual GIP/GLP-1 receptor agonist tirzepatide once weekly has induced a weight loss of about 20% in obese people without diabetes. This review describes results obtained with GLP-1 mono-agonists, GLP-1/GIP dual agonists, GLP-1/glucagon co-agonists, and the triple agonist retatrutide (GIP/GLP-1/glucagon), which have shown beneficial effect both on body weight and steatotic liver disease. A combination of semaglutide (a GLP-1 agonist) and cagrilintide (a long-acting amylin analogue) for weekly administration is currently in phase III development, and so is oral semaglutide and several non-peptide small molecule GLP-1 agonists for oral administration...The GLP-1-based therapies will change the treatment of obesity and its comorbidities including steatotic liver disease in the future...."

Journal • P2 data • Review • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=134 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=134 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P2 trial • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

A Cross-Species Atlas of the Dorsal Vagal Complex Reveals Neural Mediators of Cagrilintide's Effects on Energy Balance. (PubMed, bioRxiv) - "Indeed, activating rat area postrema Calcr cells briefly reduced food intake but failed to decrease food intake or body weight over the long term. Overall, these results not only provide a cross-species and spatial atlas of DVC cell populations but also define the molecular and neural mediators of acute and long-term cagrilintide action."

Journal • Genetic Disorders • Obesity • CALCR