Lilly Drug Saves Muscle When Added to Wegovy Weight-Loss Shot
Patients who took an experimental drug from Eli Lilly & Co. together with Novo Nordisk A/S 's Wegovy maintained muscle while losing weight, offering a potential solution to one of the key problems that's emerged with popular obesity shots.
The closely-watched study showed that patients on Wegovy combined with bimagrumab lost 22.1% of their body weight in 48 weeks, with 92.8% of that coming from the body's fat stores, according to results shared Monday at the American Diabetes Association conference in Chicago.
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Yahoo
38 minutes ago
- Yahoo
Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities
Pending a decision from the European Commission, Ozempic® (once-weekly semaglutide) will have the broadest approved label in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class, demonstrating improvements in blood sugar, weight, cardiovascular (CV) events, chronic kidney disease and peripheral arterial disease (PAD) functional outcomes1. Ozempic® is the first and only glucose-lowering treatment with proven functional benefits in people with type 2 diabetes and PAD1. The positive opinion is based on results from the phase 3b STRIDE trial, which demonstrated an improvement in walking capacity in patients with type 2 diabetes and PAD1. Additional data from STRIDE and SOUL (CV outcomes with Rybelsus® in type 2 diabetes) were presented today at the American Diabetes Association's (ADA) 85th Scientific Sessions2,3. Bagsværd, Denmark, 23 June 2025 – Novo Nordisk today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Ozempic® (once-weekly semaglutide) label to reflect the positive data from the STRIDE peripheral artery disease (PAD) functional outcomes trial. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 receptor agonist (GLP-1 RA). PAD is a manifestation of atherosclerotic cardiovascular disease (ASCVD) where a build-up of fatty deposits in the artery walls restricts blood supply to muscles, which can cause debilitating symptoms, physical limitations and poor quality of life4. 'People living with type 2 diabetes face multiple cardiometabolic challenges, yet there is a lack of treatments that address the full disease spectrum,' said Ludovic Helfgott, executive vice president, Product & Portfolio Strategy at Novo Nordisk. 'Pending a decision from the European Commission, a STRIDE label update would complete the picture for Ozempic®, making it the only GLP-1 RA to have proven risk reduction of cardiovascular death, heart attack, stroke, major kidney events and improvement in functional walking capacity in people with type 2 diabetes. Coupled with its extensive real-world evidence, Ozempic® offers best-in-class benefits for people living with type 2 diabetes and its comorbidities, helping to treat today's disease, while potentially reducing future complications.' Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission to implement the label update within approximately two months. Novo Nordisk has also filed for a label expansion of Ozempic® in the US, and a decision is expected in last quarter of 2025. Based on data from the SOUL trial, Novo Nordisk has also filed for a label expansion for Rybelsus® with the EMA and FDA. This could potentially make Rybelsus® the first and only oral GLP-1 RA with proven cardiovascular (CV) benefits. A decision is also expected in the second half of 2025. At the American Diabetes Association's (ADA) 85th Scientific Sessions, secondary data from the STRIDE, SOUL and FLOW semaglutide trials were presented: STRIDE: Secondary results showed that once-weekly semaglutide 1.0 mg consistently improved maximum walking distance in people with type 2 diabetes with symptomatic PAD compared to placebo, regardless of their type 2 diabetes characteristics2. SOUL: Secondary results showed that the CV benefits of oral semaglutide in people with type 2 diabetes and CV disease (CVD) and/or chronic kidney disease (CKD) appeared more pronounced in people with higher HbA1c levels at baseline. CV benefits were consistent across BMI categories3. FLOW: Secondary results showed that the CKD benefits of once-weekly semaglutide 1.0 mg in people with type 2 diabetes, and regardless of baseline BMI, did not seem to be explained by change in body weight5. An additional analysis demonstrated that adding semaglutide to standard of care was projected to be highly cost-effective over the longer term in people with type 2 diabetes and CKD in Denmark6. These results add to the body of evidence that supports semaglutide use across a spectrum of CV and metabolic conditions, including type 2 diabetes and CKD7, metabolic dysfunction-associated steatohepatitis (MASH)8, obesity and heart failure with preserved ejection fraction (HFpEF) with and without type 2 diabetes9–12. They also add to the well-established safety profile of semaglutide, with more than 33 million patient-years of exposure across indications since its launch in 201813. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic®, on functional capacity. The trial enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at Week 521. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. The STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep (12%) incline, compared to placebo at Week 521. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 CV outcomes trial with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on CV outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse CV events (MACE; a composite endpoint consisting of CV death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, when both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD14. The SOUL trial demonstrated a significant 14% risk reduction compared to placebo in MACE in adults with type 2 diabetes and CVD and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with proven CV benefit15. About FLOW FLOW was a randomised, double-blind, parallel-grouped, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care. The trial assessed the effect of the treatments on kidney outcomes for prevention of progression of kidney disease and risk of kidney and CV mortality in people with type 2 diabetes and CKD (defined as estimated glomerular filtration rate [eGFR] ≥50 and ≤75 mL/min/1.73 m2 with urine albumin-to-creatinine ratio [UACR] >300 and <5,000 mg/g or eGFR ≥25 and <50 mL/min/1.73 m2 with UACR >100 and <5,000 mg/g). A total of 3,533 people were enrolled in the trial, which was conducted in 28 countries at around 400 investigator sites7. The key objective of the FLOW trial was to demonstrate delay in progression of CKD and to lower the risk of kidney and CV mortality through a composite primary endpoint consisting of the following five components: onset of persistent ≥50% reduction in eGFR according to the CKD-Epidemiology Collaboration (EPI) equation compared with baseline; onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73 m2; initiation of chronic kidney replacement therapy (dialysis or kidney transplantation); death from kidney disease; or death from CVD. Confirmatory secondary endpoints included annual rate of change in eGFR (CKD-EPI), MACE (including non-fatal myocardial infarction, non-fatal stroke and CV death) and all-cause mortality7. The FLOW trial demonstrated a statistically significant and superior 24% risk reduction in kidney disease progression, and a reduction in MACE and all-cause mortality in those treated with semaglutide 1.0 mg vs placebo7. About PAD Lower extremity PAD is a severe form of ASCVD that is under-screened, under-diagnosed and impacts approximately 230 million people globally16. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life4. Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD has type 2 diabetes17. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes18. About Ozempic® Ozempic® (semaglutide) injection 0.25 mg, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes and to reduce the risk of major CV events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease19,20. Ozempic® is the only GLP-1 RA indicated to reduce the risk of worsening kidney disease and risk of death from CV events in adults with type 2 diabetes and CKD20. Ozempic® is currently marketed in 72 countries, and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide21. About Rybelsus® Rybelsus® (oral semaglutide) is a GLP-1 RA indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise22,23. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg24,25. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®24,25, together with consistent weight reduction24–26 and reduction in cardiometabolic risk factors26. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide21. 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 Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________ References 1. Bonaca MP, et al. Lancet. 2025;405:1580–1593.2. Rasouli N, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 291.3. Inzucchi SE, et al. Oral presentation at the American Diabetes Association 2025; 20–23 June 2025. Oral presentation 292.4. Aronow WS. Peripheral arterial disease of the lower extremities. Arch Med Sci. 2012;8:375–388.5. Mann JFE, et al. LB poster presentation at the American Diabetes Association 2025; 20–23 June 2025. LB poster presentation 1971.6. Rossing P, et al. Poster presentation at the American Diabetes Association 2025; 20–23 June 2025. McCormick Place Convention Center Chicago, US. Poster presentation 72.7. Perkovic V, et al. N Engl J Med. 2024;391:109–121.8. Sanyal AJ, et al. N Engl J Med. 2025;392:2089–2099.9. Kosiborod MN, et al. N Engl J Med. 2023;389:1069–1084.10. Butler J, et al. Lancet. 2024;403:1635–1648.11. Davies M, et al. Lancet. 2021;397:971–984.12. Kosiborod MN, et al. N Engl J Med. 2024;390:1394–1407.13. Novo Nordisk data on file (IQVIA MIDAS® monthly volume sales data for the time period Jan 2018 to July 2024 [40 countries]).14. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.15. McGuire DK, et al. N Engl J Med. 2025;392:2001–2012.16. Gornik HL, et al. Circulation. 2024;149:e1313-e1410.17. Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969.18. Sillesen H, et al. Eur Heart J. 2021;42:ehab724.2027.19. EMA. Ozempic® (once-weekly semaglutide) SmPC. Available at: Last accessed June 2025.20. FDA. Ozempic® (once-weekly semaglutide) USPI. Available at: Last accessed June 2025.21. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. 22. FDA. Rybelsus® (oral semaglutide) USPI. Available at: Last accessed June 2025.23. EMA. Rybelsus® (oral semaglutide) SmPC. Available at: Last accessed June 2025.24. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.25. Rosenstock J, et al. JAMA. 2019;321:1466–1480.26. Husain M, et al. N Engl J Med. 2019;381:841–851. Attachment PR250623-ADA-Diabetes-CHMP
Fast Company
43 minutes ago
- Fast Company
Hims & Hers stock plummets after Novo Nordisk ends partnership over 'knock-off' Wegovy
This morning, the Danish pharmaceutical giant Novo Nordisk announced the abrupt end of its brief partnership with telehealth company Hims & Hers Health, Inc. (NYSE: HIMS), citing concerns over Hims & Hers' 'knock-off' weight loss drugs. Now, Hims & Hers' shares are plummeting as investors react to the news. It's the latest update in a somewhat volatile year for Hims & Hers. Just this April, the company's stock spiked after it initially announced a collaboration with Novo Nordisk that allowed Hims & Hers to sell Novo Nordisk's FDA-approved weight loss drug, Wegovy, through its platform. But less than two months later, that partnership is fracturing after Novo Nordisk's claim that Hims & Hers engaged in 'deceptive promotion and selling of illegitimate, knockoff versions of Wegovy that put patient safety at risk.' At the time of this writing, HIMS stock is down 32.6% since market open. Here's what to know about the break-up: The shortage that fueled knock-off Wegovy Back in 2022, the Food and Drug Administration (FDA) declared a shortage of GLP-1 medications including Ozempic and Wegovy. Under this shortage notice, pharmacies were permitted to make compounded versions of the brand name drugs using their active ingredient, semaglutide, and sell them at a lower cost. Hims & Hers was one company that took part in selling a compounded—and non-FDA-approved—version of Wegovy. Then, this February, the FDA announced that Ozempic and Wegovy were no longer categorized under a shortage. With the brand name drugs fully back on the market, the FDA gave compounders 60 to 90 days to stop making copies of the patented drugs. At the time, Hims & Hers stated in a regulatory filing that, while it saw pathways to continue offering access to certain compounded GLP-1s after the shortage, it could not 'guarantee that we will be able to continue offering these products in the same manner, to the same extent, or at all.' However, an analyst told Reuters that Hims & Hers appeared poised to continue selling compounded semaglutide using 'personalized doses' after the shortage officially ended. Why is Novo Nordisk cutting ties now? In the wake of the FDA's shortage notice, Hims & Hers announced in April that it was entering a 'long-term collaboration' with Novo Nordisk to offer Wegovy directly to its consumers. Now, though, Novo Nordisk is breaking off the commitment over claims that Hims & Hers has not acted fast enough to stop selling its compounded GLP-1. Other telehealth companies, like Ro and Noom, have similarly faced criticism for continuing to sell their own compounded GLP-1 despite agreements with Eli Lilly, the maker of Zepbound. In an email to Fast Company, a Novo Nordisk spokesperson explained that 'semaglutide compounding is permitted under US compounding laws only in rare instances,' adding that other companies it's working with have 'demonstrated a good faith effort to transition patients to authentic, FDA-approved Wegovy.' However, the spokesperson continued, 'after over one month into the collaboration, Hims & Hers Health, Inc. has failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of 'personalization' and are disseminating deceptive marketing that puts patient safety at risk. This is unacceptable and that is why we have decided to end the collaboration.' That personalization, involves offering the same drug; however, at different doses. In a press release published this morning, Novo Nordisk also noted that it is 'deeply concerned' about knock-off drugs 'made with foreign illicit active pharmaceutical ingredients.' 'Based on Novo Nordisk's investigation, the 'semaglutide' active pharmaceutical ingredients that are in the knock-off drugs sold by telehealth entities and compounding pharmacies are manufactured by foreign suppliers in China,' the release reads. 'According to a report from the Brookings Institute, FDA has never authorized or approved the manufacturing processes used by any of these foreign suppliers to make semaglutide, nor has FDA ever reviewed or authorized the quality of the 'semaglutide' they produce.' Hims & Hers did not immediately respond to Fast Company 's request for comment on Novo Nordisk's claims. On X, Novo Nordisk CEO Andrew Dudam said 'Novo Nordisk's commercial team increasingly pressured us to control clinical standards and steer patients to Wegovy regardless of whether it was clinically best for patients. We refuse to be strong-armed by any pharmaceutical company's anticompetitive demands that infringe on the independent decision making of providers and limit patient choice.' He went on to say 'We will continue to offer access to a range of treatments, including Wegovy, to ensure providers can serve the individual needs of patients.'
CBS News
43 minutes ago
- CBS News
Cooling centers open across Pittsburgh area in response to extreme heat
With extreme heat remaining in place across the Pittsburgh region through at least Wednesday, several cooling centers have opened to give residents a place to escape the dangerous temperatures. While the heat is here, residents are encouraged to check on neighbors, friends, and family, especially those who are older or medically vulnerable. Heat is the leading weather-related cause of death nationwide, surpassing the fatalities caused by floods, tornadoes, hurricanes, and lightning. Tips to keep yourself safe during extreme heat include drinking plenty of water to stay hydrated, even if you are not thirsty; keeping cool by using wet towels, putting feet in cool water, and taking cool showers; spend as much time as possible in cool or air-conditioned buildings; staying out of the sun during the hottest part of the day; wear sunscreen and hats with other loose-fitting clothing; and never leave pets or children in vehicles. Cooling centers opening Unless otherwise noted, cooling centers will operate from 8 a.m. to 7 p.m. from Monday through Wednesday. A list of operational cooling centers is below. Beechview Healthy Active Living Community Center 1555 Broadway Avenue Pittsburgh, Pa. 15216 Brighton Heights Healthy Active Living Community Center 3515 McClure Avenue Pittsburgh, Pa. 15212 First Presbyterian Church of Edgewood Open Tuesday and Wednesday from 9 a.m. to 2 p.m. 120 E. Swissvale Avenue Edgewood, Pa. 15218 Greenfield Healthy Active Living Community Center 745 Greenfield Avenue Pittsburgh, Pa. 15217 Homewood Healthy Active Living Community Center 7321 Frankstown Road Pittsburgh, Pa. 15208 Shaler North Hills Library 1822 Mount Royal Boulevard Glenshaw, Pa. 15116 Sheraden Healthy Active Living Community Center 720 Sherwood Avenue Pittsburgh, Pa. 15204 South Side Healthy Active Living Community Center 12th and Bingham Streets Pittsburgh, Pa. 15203
