Novo Nordisk Advances Amycretin for Weight Management to Phase 3

Analysis reveals significant industry trends and economic implications

Release Date

2025-06-13

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

Novo Nordisk announced its advancement of both subcutaneous and oral amycretin into phase 3 clinical development for weight management. This decision follows positive feedback from regulatory authorities after end-of-phase 2 interactions. Amycretin, a long-acting GLP-1 and amylin receptor agonist, is designed for convenient treatment of overweight or obese adults, and also for adults with type 2 diabetes. Phase 3 trials are planned to begin in the first quarter of 2026, focusing on adults with overweight or obesity. The company has conducted phase 1 and 1b/2a trials evaluating the safety, tolerability, pharmacokinetics, and efficacy of both oral and subcutaneous amycretin.

Key Highlights

  • Novo Nordisk will advance subcutaneous and oral amycretin to Phase 3 clinical development for weight management.
  • The decision is based on positive feedback from regulatory authorities.
  • Phase 3 trials are planned to begin in Q1 2026, focusing on adults with overweight or obesity.
  • Amycretin is a long-acting GLP-1 and amylin receptor agonist.

Incidence and Prevalence

The provided text does not contain the latest estimates of incidence and prevalence of Weight management on a global basis. However, it does offer information on the incidence, prevalence, and burden of various other health conditions, including:

  • Spinal cord injury (SCI): In 2019, there were an estimated 0.9 million incident cases, 20.6 million prevalent cases, and 6.2 million years lived with disability (YLDs) globally.
  • Vertebral fracture: In 2019, there were an estimated 8.6 million incident cases, 5.3 million prevalent cases, and 0.55 million YLDs globally.
  • Metabolic diseases: The global prevalence of metabolic diseases (type 2 diabetes mellitus, hypertension, and non-alcoholic fatty liver disease) has risen over the past two decades.
  • Shoulder pain: The community prevalence of shoulder pain varied widely, with a median of 16% (range 0.67% to 55.2%).
  • Polycystic ovary syndrome: Among a US cohort, the incidence was stable over time, with an overall rate of 42.5 per 10,000 person-years. The prevalence in 2019 was 5.2%.
  • Hepatitis C virus (HCV) among people who inject drugs: Global pooled HCV incidence was 13.9 per 100 person-years pre-2015 and 8.6 per 100 person-years for 2015-2021.
  • Non-communicable diseases (NCDs): In 2021, NCDs accounted for 7.3 trillion global cases, 43.8 million deaths, and 1.73 billion DALYs.
  • Autoimmune hepatitis (AIH): Global pooled incidence and prevalence were 1.28 cases per 100,000 inhabitant-years and 15.65 cases per 100,000 inhabitants, respectively.
  • Tuberculosis (TB): Global TB incidence decreased from 8.6 million cases in 1990 to 8.4 million cases in 2021.
  • Atrial fibrillation (AF): In 2017, there were 37.57 million prevalent cases and 3.05 million incident cases of AF globally.
  • Knee osteoarthritis: The global prevalence in 2019 was ~364.6 million, with an age-standardized prevalence of 4376.0 per 100,000.
  • Type 2 diabetes mellitus (T2DM): The global age-standardized incidence, prevalence, mortality, and DALY rates in 2019 were 259.9, 5282.9, 18.5, and 801.5 per 100,000 population, respectively.
  • Cancer: Lung cancer remained the most common cancer and leading cause of cancer death worldwide in 2022.
  • Inflammatory bowel disease (IBD): In 2019, there were 4.9 million global cases of IBD.
  • Attention-deficit/hyperactivity disorder (ADHD): In 2019, the global age-standardized incidence and prevalence were estimated at 0.061% and 1.13%, respectively.
  • Uterine fibroids: Global incident cases, prevalent cases, and YLDs increased from 1990 to 2019.
  • HIV/AIDS: Global HIV incidence peaked in 1997 at 3.3 million new infections. In 2015, there were 38.8 million people living with HIV/AIDS.
  • Idiopathic pulmonary fibrosis (IPF): The adjusted incidence and prevalence of IPF were estimated to be in the range of 0.09-1.30 and 0.33-4.51 per 10,000 persons, respectively.
  • Syphilis: The global number of incident cases and age-standardized incidence rate increased from 1990 to 2019.
  • Systemic sclerosis (SSc): The global incidence and prevalence were estimated to be 8.64 per 100,000 person-years and 18.87 per 100,000 persons, respectively.
  • Periodontitis: The age-standardized rate of prevalence, incidence, and DALYs increased worldwide from 1990 to 2019.
  • Urinary tract infections (UTIs): In 2019, there were more than 404.6 million UTIs globally.
  • Acromegaly: Overall annual incidence rates were ~11 cases per million person-years, and prevalence was approximately 78 cases per million.
  • Silicosis: Global incident and prevalent cases, and DALYs increased, but age-standardized rates showed downward trends.
  • Amyotrophic lateral sclerosis (ALS): Incidence ranged from 0.26 to 23.46 per 100,000 person-years, and point prevalence ranged from 1.57 to 11.80 per 100,000.
  • Psoriatic arthritis (PsA): The worldwide prevalence was estimated at 112 per 100,000 adults.
  • Alcohol-related liver disease (ARLD): The global prevalence was 4.8%.
  • Depression: There is a predominant increasing trend in the likelihood of experiencing depression over time.
  • Noma: No new estimate of global incidence and prevalence could be calculated due to limited data.
  • Craniosynostosis: The overall birth prevalence was 5.9 per 10,000 live births.
  • Alpha- and beta-thalassemia: Prevalence estimates varied across countries.
  • Adverse effects of medical treatment (AEMT): Global incidence increased, while mortality decreased between 1990 and 2017.
  • Primary brain tumors: The overall incidence rate of all brain tumors was 10.82 per 100,000 person-years.
  • Dental caries: Age-standardized prevalence of caries in permanent and deciduous teeth decreased.
  • Rosacea: The global prevalence was estimated at 5.46% of the adult population.
  • Strabismus: The pooled prevalence estimate of any strabismus was 1.93%.
  • Oropharyngeal cancer (OPC): Worldwide, 98,400 new cases and 48,100 deaths were estimated in 2020.
  • Bipolar disorder: Incidences increased by 47.74% from 1990 to 2017, and DALYs increased by 54.4%.
  • Rheumatoid arthritis: The global prevalence in 2020 was estimated at 17.6 million people.
  • Hip fracture: Incidence, prevalence, and YLD rates increased in patients aged 55+ from 1990 to 2019.
  • Acne vulgaris: Global incident cases, prevalent cases, and DALYs increased, with an overall increase of approximately 48% compared with 1990.
  • Giant cell arteritis (GCA) and polymyalgia rheumatica (PMR): Incidence of GCA is higher in Northern European ancestry populations.
  • Retinal vein occlusion (RVO): Global prevalence increased with age in 2015.
  • Hypertensive disorders of pregnancy: Incidence increased, but the age-standardized rate decreased from 1990 to 2019.
  • Latent tuberculosis infection (LTBI): Approximately one-fourth of the world's population is estimated to be infected.
  • Hydrocephalus: Nearly 400,000 new cases of pediatric hydrocephalus are estimated to develop worldwide each year.
  • Thyroid cancer: An estimated 821,214 new cases and 47,507 deaths occurred worldwide in 2022.
  • Drug use disorders: The burden continues to increase globally.
  • Colorectal cancer: Over 1.9 million new cases and 930,000 deaths were estimated in 2020.
  • Chronic low back pain: Several factors were associated with higher prevalence in older adults.
  • Type 2 diabetes in children and adolescents: Incidence and prevalence vary substantially among countries.
  • Asthma: Incidence and prevalence are high, but DALYs and deaths have declined.
  • Non-small cell lung cancer: Global incidence trends have started to decline.
  • Sarcoidosis: Prevalence and incidence vary greatly depending on the region.

For specific details on any of these conditions, please refer to the original text.

Amycretin, a unimolecular GLP-1/amylin receptor dual agonist, is currently under investigation for its potential in treating type 2 diabetes in addition to weight management. While specific intervention models for ongoing trials are not detailed in the provided text, the information suggests that it's likely being explored as a once-weekly subcutaneous injection, similar to other long-acting GLP-1 and amylin analogs like semaglutide and cagrilintide.

The provided abstracts focus heavily on the combination of semaglutide and cagrilintide (CagriSema) for both weight management and type 2 diabetes. These studies highlight the synergistic effects of targeting both GLP-1 and amylin receptors for improved glycemic control and weight loss. Given the structural similarities and overlapping mechanisms of action between amylin and GLP-1, it is reasonable to infer that Amycretin trials might follow similar protocols to those used for CagriSema. This could involve comparing Amycretin to placebo, semaglutide alone, and potentially other established diabetes medications like metformin or SGLT2 inhibitors. The trials would likely assess changes in HbA1c, body weight, fasting plasma glucose, and other relevant parameters over a period of several weeks or months. Further research is needed to confirm the specific trial designs and outcomes for Amycretin in type 2 diabetes.

Company drugs in pipeline

Novo Nordisk has several drugs in its pipeline for various indications, most notably type 2 diabetes (T2D) and obesity. They are also exploring treatments for related conditions like non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD).

Type 2 Diabetes: * Semaglutide (Ozempic): A once-weekly subcutaneous GLP-1 analog approved for T2D. It lowers blood glucose by stimulating insulin release and promotes weight loss. * Insulin icodec: A once-weekly basal insulin analog in phase 2 trials. It aims to provide similar efficacy and safety to once-daily insulin glargine U100. * Oral semaglutide (Rybelsus): An oral formulation of semaglutide, representing a significant milestone in oral peptide delivery for T2D. * IDegLira: A fixed-ratio combination of insulin degludec and liraglutide, offering improved glycemic control compared to individual components.

Obesity: * Semaglutide: Being investigated at a 2.4 mg dose for weight management in individuals with obesity with and without T2D. The STEP program of clinical trials is exploring its efficacy and safety. * Cagrilintide: A long-acting amylin analog in clinical trials for obesity. It has shown significant weight loss when used alone or in combination with semaglutide.

NASH and NAFLD: * Semaglutide: Undergoing clinical development for NASH and NAFLD.

Other Areas: * Hemophilia B: Novo Nordisk developed N9-GP (nonacog beta pegol), a glycoPEGylated extended half-life recombinant factor IX for treating bleeding episodes in hemophilia B patients.

Historically, Novo Nordisk has been a leader in insulin development, starting with Insulin "Leo" tablets in 1923 and continuing with various innovations like NovoPen delivery devices. Their focus remains on metabolic diseases, with a strong emphasis on developing new GLP-1 analogs and exploring combination therapies.