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Novo Nordisk's CagriSema Shot Tied to Greater Weight Loss at Lower Doses

Novo Nordisk's CagriSema Shot Tied to Greater Weight Loss at Lower Doses

Bloomberg4 hours ago

Novo Nordisk A/S's next-generation obesity shot CagriSema helped patients lose weight in large studies despite only about three-quarters of the patients ever making it to the highest dose. Surprisingly, patients who chose to stick with a lower dose lost more weight on average.
The studies allowed patients to stop at lower doses of the drug, an unusual option in a trial. Researchers presenting new data Sunday at the American Diabetes Association meeting in Chicago say the findings offer clues as to how the drug would be used in real life. There's a group of people who respond very well to this medicine, said Timothy Garvey, director of the Diabetes Research Center at the University of Alabama at Birmingham, who helped lead the trials.

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Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine
Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine

Business Upturn

time24 minutes ago

  • Business Upturn

Novo Nordisk A/S: CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine

By GlobeNewswire Published on June 22, 2025, 18:00 IST Data presented simultaneously at the American Diabetes Association's ® 85 th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions 1 85 Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks 1 * The REDEFINE clinical programme is ongoing to further investigate efficacy and safety of CagriSema, including recently initiated REDEFINE 112 Bagsværd, Denmark, 22 June – Today, The New England Journal of Medicine (NEJM) published results from Novo Nordisk's phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.1 REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.1 These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association's (ADA) 85th Scientific Sessions and published in NEJM . 'In REDEFINE 1, participants saw significant and clinically meaningful weight loss under a protocol that allowed investigators to maintain patients on a submaximal dose if deemed best for the patient. We also witnessed low, single-digit discontinuation rates due to adverse events in both REDEFINE 1 and 2,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. 'These results reinforce our confidence in CagriSema, and we continue to study the potential of this combination through the REDEFINE trials.' CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment.1* When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group.1** In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m2) at the end of treatment, from a mean BMI of 38 kg/m2 at the start of treatment. In the placebo group,10.2% reached that threshold at 68 weeks.1 Select confirmatory secondary endpoints showed that if all participants adhered to treatment 40.4% of those receiving CagriSema achieved a body weight reduction of ≥25%.* Additionally, 23.1% lost ≥30% of their body weight.1* When applying the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ≥25% body-weight reduction and 19.3% achieved ≥30% body-weight reduction.1** In a prespecified analysis of 252 participants, the relative reduction in fat and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema versus –5.7% and –4.3% for the placebo group, respectively.1 'In REDEFINE 1, CagriSema provided weight loss in the highest range of efficacy observed with existing weight loss interventions,' said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. 'Investigators were allowed some flexibility in dose adjustments to balance efficacy and safety, but regardless of dose adjustments participants lost significant weight. These findings are relatable to clinical practice, where dosing is often adjusted based on individual needs and clinical judgement.' Safety data generated in the REDEFINE 1 and 2 trials were comparable with the GLP-1 RA class. Overall, discontinuation rates due to adverse events were low, with 6% for CagriSema versus 3.7% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2.1,3 In REDEFINE 1, adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs. 39.9% with placebo), including nausea (55% vs. 12.6 %), constipation (30.7% vs. 11.6%), vomiting (26.1% vs. 4.1%) and were mostly transient and mild-to-moderate in severity.1 Results from REDEFINE 2, a phase 3 study that evaluated the efficacy and safety of CagriSema plus lifestyle interventions in adults with obesity and type 2 diabetes (T2D), were also simultaneously presented during a scientific symposium at the ADA's Scientific Sessions and published in NEJM .3 In REDEFINE 2, if all participants adhered to treatment, the estimated mean change in body weight from baseline to week 68 was –15.7% with CagriSema versus –3.1% with placebo.3* When applying the treatment policy estimand, the estimated mean change in body weight from baseline to week 68 was –13.7% with CagriSema versus –3.4% with placebo.3** A greater proportion of participants receiving CagriSema, compared with placebo, reduced their body weight by > 5% (83.6% vs. 30.8% of participants), ≥10% (65.6% vs. 10.3%), ≥15% (43.9% vs. 2.4%), and ≥20% (22.9% vs. 0.5%;).3 The safety results from CagriSema in REDEFINE 2 were similar to those reported in REDEFINE 1.3 The REDEFINE clinical programme will continue to assess the efficacy and safety of CagriSema. Most recently, Novo Nordisk initiated the REDEFINE 11 trial with the first patient visit occurring in early June 2025. REDEFINE 11 will explore further weight loss potential and safety of CagriSema 2.4 mg / 2.4 mg through a longer trial duration and other protocol changes compared to REDEFINE 1 and 2. * Based on the trial product estimand; this estimand estimates what the effect would be if all participants adhered to treatment ** Based on the treatment policy estimand: treatment effect regardless of treatment adherence About CagriSema CagriSema is being investigated by Novo Nordisk as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. About the REDEFINE clinical trial programme REDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. REDEFINE 1 and REDEFINE 2 have enrolled approximately 4,600 adults with overweight or obesity. REDEFINE 1 was a double-blind, placebo-and active-controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes. REDEFINE 2 was a double-blind, randomized, placebo- and controlled 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight. Multiple REDEFINE clinical trials are currently underway including: REDEFINE 3, an event-driven cardiovascular outcomes phase 3 trial; REDEFINE 4 an 84-week head-to-head efficacy and safety phase 3 trial of once-weekly CagriSema versus once-weekly tirzepatide; and REDEFINE 11, a phase 3 trial with longer duration and other protocol changes compared to REDEFINE 1 and 2. About obesity Obesity is a serious chronic, progressive, and complex disease that requires long-term management.4–6 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.4,6 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.7,8 About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information References: Garvey WT, Blüher MD, Contreras CKO, et al. CagriSema in Adults with Overweight or Obesity. New England Journal of Medicine 2025. doi: 10.1056/NEJMoa2502081 A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term. Last Accessed: June 2025. Available at: Davies MJ, Harpreet S, Bajaj MD, et al. CagriSema in Adults with Overweight or Obesity and Type 2 Diabetes. New England Journal of Medicine 2025. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity . 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev . 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract . 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: June 2025. Available at: World Obesity Federation. World Obesity Atlas 2023. Last accessed: June 2025. Available at: Attachment Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.

Campus notes: June 22, 2025
Campus notes: June 22, 2025

Yahoo

time26 minutes ago

  • Yahoo

Campus notes: June 22, 2025

Teagan Graham, Reading, graduated from the University at Buffalo, N.Y., with a bachelor's degree in health and human services/early childhood education. York College The following area students received degrees from York College of Pennsylvania: Master of education: Julianna Kusy, Kutztown; Isabelle Popoter, Spring Township. Master of science in nursing: Elyse Batson, Exeter Township. Bachelor of arts: Isabella Antos, South Heidelberg Township; Lauryn Johnson, Exeter Township; Isabella Hoeltzel, Leesport; Elizabeth Trumbore, Temple. Bachelor of business administration: Gabriel Trevena, South Heidelberg Township. Bachelor of science: Brett Reinert, Douglassville; Haley Akins, Markus Jeschonnek and Brianna Endy, Exeter Township; Alexander LaVerdure, Oley Township;. Bachelor of science in nursing: Morgan Sauers, Gilbertsville; Taryn Boyer, Temple. Items are supplied by the colleges involved.

What's the difference between an extreme heat watch and warning?
What's the difference between an extreme heat watch and warning?

Yahoo

timean hour ago

  • Yahoo

What's the difference between an extreme heat watch and warning?

States across the Central and Eastern U.S. are under extreme heat watches and warnings as the areas are facing "dangerous heat," according to the National Weather Service. "Though record high temperatures are expected in the coming days, the duration of the heat, as demonstrated by the numerous record warm morning lows, will make this period especially oppressive," the National Weather Service posted on X June 20. The weather service has issued extreme heat warnings for areas in over a dozen states, as they face the highest temperatures of the year so far. It also issued extreme heat watches in several states and Washington D.C., according to an advisory issued to the agency's website. Here's everything you need to know about the heat wave. Portions of the following states have been placed under an extreme heat warning, according to the National Weather Service: Indiana Iowa Massachusetts Michigan Minnesota Missouri Nebraska New York Ohio Pennsylvania Rhode Island South Dakota Vermont West Virginia Areas where dangerous heat is possible are placed under an extreme heat warning and are asked to prepare in case it happens. Areas where dangerous heat "is happening or about to happen" are placed under an extreme heat warning, according to the weather service. While areas that are placed on a watch are asked to reschedule any planned outdoor activities, people in areas placed under warnings are told to avoid any heavy activity and direct sunlight. People facing extreme heat should do the following, according to NWS: Drink plenty of fluids Stay in an air-conditioned room Stay out of the sun Check up on relatives and neighbors Do not leave young children and pets in unattended vehicles Wear lightweight and loose-fitting clothing outdoors Limit strenuous activities to early morning or evening The extreme heat could negatively impact people's health. "Heat-related illnesses increase significantly during extreme heat and high humidity events," according to the National Weather Service. The following factors increase the possibility of a heat-related illness, according to the National Park Service: High humidity High elevation Strenuous activity Age: Infants, young children and people over 65 are more susceptible to heat illness Pregnancy Obesity Heart disease Poor circulation Fever Mental illness Dehydration Sunburn Prescription drug and alcohol use There are multiple forms of heat illnesses, but heatstroke is the deadliest and most dangerous, according to the NPS. The following are symptoms of heatstroke, according to the Centers for Disease Control and Prevention: Body temperature of 103 degrees or higher Skins that is hot, red, dry or damp Fast, strong pulse Headache Dizziness Nausea Confusion Losing consciousness In the case of a heatstroke, the CDC recommends people do the following: Call 911 immediately Move the person suffering from heatstroke to a cool location Lower the person's body temperature with a cool cloth or bath Do not give the person suffering from a heatstroke water or anything to drink Julia is a trending reporter for USA TODAY. Connect with her on LinkedIn, X, Instagram and TikTok: @juliamariegz, or email her at jgomez@ This article originally appeared on USA TODAY: What's the difference between an extreme heat watch and warning?

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