Liraglutide

Data highlights The STEP Young phase 3 trial met its primary endpoint, demonstrating greater body mass index (BMI) reduction in children aged 6 to under 12 treated with once-weekly subcutaneous semaglutide compared with placebo Both groups received lifestyle modification throughout the trial, including reduced-calorie diet and increased physical activity 40.4%* of the children treated with semaglutide were no longer classified as having obesity** after 68 weeks compared with non (0%) treated with placebo The overall safety and tolerability of semaglutide were consistent with those seen in adults and adolescents trials with semaglutide Bagsværd, Denmark, 7 September 2026 – Novo Nordisk today announced first results from the STEP Young phase 3 trial, evaluating once-weekly semaglutide in combination with a reduced-calorie diet and increased physical activity in children aged 6 to under 12 years old with obesity. Obesity prevalence is growing in this age group, for whom there are limited clinically tested and approved treatments available when lifestyle modifications are not sufficient. At baseline, more than 85% of the children had either class II or III severe obesity (corresponding to a BMI above or equal to 35 and 40 in adults, respectively). The trial met its primary endpoint demonstrating superior BMI reduction at week 68 in the group taking semaglutide compared with the placebo group. The results showed that 40.4%* of those treated with semaglutide were no longer classified as having obesity** at week 68, compared with none of those treated with placebo. This means that semaglutide helped two out of five of the children reduce their BMI to a normal weight or overweight classification compared with none of the children in the placebo group. Both groups received lifestyle modification throughout the trial, including reduced-calorie diet and increased physical activity. “Childhood obesity is particularly concerning due to both immediate and enduring impacts on health, including a strong predilection to adult obesity and increased risk for the early emergence of obesity-related complications,” said Ania M. Jastreboff, MD, PhD, Professor of Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology) at the Yale and Director of the Yale Obesity Research Center (Y-Weight). “Most of the children in the STEP Young trial were classified as having severe (class II or III) obesity at baseline, yet treatment with semaglutide resulted in a BMI percentile category below the obesity threshold in approximately 40% of the children within about a year of treatment,” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Children living with obesity experience cardiovascular disease risk factors, alongside depression, eating disorders, and bullying, with studies showing that their quality of life is comparable to children undergoing cancer treatment. 1-3 Without effective intervention, childhood obesity strongly tracks into adulthood 1 , where obesity-related complications emerge earlier and more severely, 1-3 substantially shortening life expectancy. 4 An estimated 177 million children aged 5 to 19 were living with obesity in 2025, and this figure is projected to rise to 228 million by 2040. 5 "For children living with obesity and their families, health challenges can begin early and affect wellbeing throughout life,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo Nordisk. “As a pioneer in paediatric obesity medicine, we are encouraged by the positive STEP Young results and semaglutide’s potential to help children living with obesity who need medical treatment, alongside lifestyle changes, to better manage their obesity. This may prevent serious health risks later in life.” The overall safety and tolerability of semaglutide observed in STEP Young were consistent with previous Novo Nordisk paediatric and adult trials with semaglutide and liraglutide, and no new safety concerns were identified. Furthermore, no safety concerns were identified for growth or pubertal development. Detailed STEP Young results will be presented at The Obesity Society’s annual meeting ObesityWeek 2026, 14-17 November in Washington DC, United States. ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); * Based on the trial product estimand: treatment effect if all children adhered to treatment **Based on CDC.gov sex- and age-specific BMI growth charts. Using percentiles to define BMI categories in children is important because they are still growing. In children, obesity is defined as a BMI at or above the 95th percentile for age and sex. Obesity classes II and III in children are defined as a BMI ≥120% and ≥140% of the 95th percentile, respectively. About the STEP Young trial The STEP Young trial is conducted according to regulatory authorities’ post marketing requirements for the semaglutide clinical phase 3 development program thus follows the phase 3 results of semaglutide 2.4 mg in adults and adolescents with obesity. The phase 3 STEP Young is a randomised, double-blind, placebo-controlled, multinational trial investigating safety and efficacy of semaglutide compared with placebo in 165 children with obesity aged 6 to <12 years, both in combination with reduced-calorie diet and increased physical activity. The children received a maximum dose of either 1.7 mg or 2.4 mg of semaglutide, based on their weight at the start of the trial. ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); Endpoint Description Population Timepoint Primary endpoint Change in BMI (%) from baseline (week 0) to week 68 Children aged 6 to under 12 years Week 68 Confirmatory secondary endpoint Improvement in BMI classification** from baseline to week 68 Children aged 6 to under 12 years Week 68 Supportive secondary endpoints Changes in anthropometric measures, cardiovascular risk factors, glucose metabolism, and body composition (DXA subgroup) Children aged 6 to under 12 years Week 68 / Week 104 **Based on CDC.gov sex- and age-specific BMI growth charts. Using percentiles to define BMI categories in children is important because they are still growing. In children, obesity is defined as a BMI at or above the 95th percentile for age and sex. Obesity classes II and III in children are defined as a BMI ≥120% and ≥140% of the 95th percentile, respectively. About semaglutide Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that mimics the effects of the naturally occurring hormone GLP-1, which regulates blood sugar and body weight. Semaglutide has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease, and other related cardiometabolic diseases. Semaglutide is marketed under the brand names Wegovy ® (injection or tablet), Ozempic ® (injection or tablet), and Rybelsus ® (tablet). About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. O ur 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 66,700 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information ezstandalone.cmd.push(function () { ezstandalone.showAds(134); }); Novo Nordisk Media: Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 USMediaRelations@novonordisk.com Novo Nordisk Investors: Michael Novod +45 3075 6050 nvno@novonordisk.com Sina Meyer +45 3079 6656 azey@novonordisk.com Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com Christoffer Togo Solgaard-Tullin +45 3079 1471 cftu@novonordisk.com Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com Alex Bruce (US) +1 640 230 0276 axeu@novonordisk.com Frederik Taylor Pitter (US) +1 609 613 0568 fptr@novonordisk.com References Hampl SE, Hassink SG, Skinner AC, et al. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics 2023; 151 Kumar S, Kelly AS. Review of Childhood Obesity: From Epidemiology, Etiology, and Comorbidities to Clinical Assessment and Treatment. Mayo Clin Proc 2017; 92: 251-65. Schwimmer JB, Burwinkle TM, Varni JW. Health-related quality of life of severely obese children and adolescents. Jama 2003; 289: 1813-9. Wiedemann UCH, van den Akker ELT, Barber TM, et al. Early-Onset of Obesity Model: Impact of Early-Onset Obesity on Comorbidity Risk and Life Expectancy. Obes Facts 2026; 19: 265-79. World Obesity Federation. World Obesity Atlas 2026. Available at: (accessed August 2026)​ Attachment PR260907-STEP-Young-topline

Aug 25, 2026 Leave a message Meta-analytic efficacy across STEP and phase 2 trials favored semaglutide by −11.85% mean percentage weight loss versus placebo, with heterogeneity eliminated after excluding an intensive lifestyle protocol. Gastrointestinal adverse events increased materially with semaglutide (RR 1.62), and adverse-event discontinuation more than doubled (RR 2.62), while pancreatitis and cholelithiasis remained uncommon. Network evidence in nondiabetic populations linked semaglutide to higher nausea, vomiting, diarrhea, constipation, plus signals for GERD and abdominal distention versus other GLP-1 RAs. Comparative network meta-analysis ranked tirzepatide doses ahead of semaglutide 2.4 mg for maximal weight reduction; serious adverse-event risk reached significance for semaglutide and liraglutide, not tirzepatide. Counseling should emphasize titration-phase symptom anticipation, adherence to gradual dose escalation, and concurrent lifestyle intervention, given limited long-term follow-up and uncertainty around post-discontinuation weight regain. Data show semaglutide's weight loss in patients without diabetes but show how its gastrointestinal tolerability and efficacy compare with other GLP-1s. A systematic review and meta-analysis published in Medicine examined 4 randomized controlled trials encompassing 3613 participants with overweight or obesity but without type 2 diabetes, comparing subcutaneous semaglutide against placebo.1 Across the pooled cohort of 2350 patients receiving semaglutide and 1263 receiving placebo, the mean difference in percentage weight loss favored semaglutide by 11.85% (95% CI, −12.81 to −10.90; P < .00001). The trials showed moderate heterogeneity (I² = 43%), which the study authors attributed largely to one trial's unique protocol combining a very-low-calorie diet with a higher physical activity regimen; excluding that trial reduced heterogeneity to 0%.1 "Subcutaneous semaglutide is an effective treatment for weight reduction in adults with overweight or obesity without type 2 diabetes mellitus but is associated with an increased risk of gastrointestinal adverse events, particularly nausea, vomiting, diarrhea, and constipation, as well as higher treatment discontinuation," the study authors concluded.1 The Medicine meta-analysis found that overall gastrointestinal adverse events were significantly more common with semaglutide than placebo, with a risk ratio (RR) of 1.62 (95% CI, 1.45-1.82; P < .00001), though heterogeneity was substantial (I² = 81%).1 Treatment discontinuation due to adverse events was more than 2.5 times as likely with semaglutide (RR, 2.62; 95% CI, 1.70-4.03; P = .001), with discontinuation rates of 6% in the semaglutide group compared with 2.9% in the placebo group. Serious adverse events, including acute pancreatitis and cholelithiasis, were uncommon across the included trials.1 A separate systematic review and dose-response network meta-analysis published in the International Journal of Obesity, which pooled 39 studies and 33,354 individuals, offers a more granular look at how semaglutide's gastrointestinal profile compares with other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in nondiabetic patients with overweight or obesity.2 That analysis found semaglutide was associated with significantly increased risk across all 4 major gastrointestinal adverse events: nausea (RR, 2.95; 95% CI, 2.61-3.32), vomiting (RR, 4.21; 95% CI, 3.58-4.95), diarrhea (RR, 1.77; 95% CI, 1.47-2.14), and constipation (RR, 2.10; 95% CI, 1.67-2.63).2 Notably, semaglutide was also the only agent in that analysis significantly associated with increased risk of gastroesophageal reflux disease (RR, 2.43; 95% CI, 1.10-5.37) and abdominal distention (RR, 1.42; 95% CI, 1.13-1.79). The dose-response analysis found that for most GLP-1 RAs, including semaglutide, the risk of nausea, vomiting, constipation, and decreased appetite rose quickly at lower doses before plateauing at higher doses.2 The review's authors noted that "even mild but persistent symptoms can lead to treatment discontinuation, particularly in nondiabetic individuals using these agents primarily for weight management, who may have lower thresholds for tolerability than diabetic patients."2 A third analysis, a systematic review and network meta-analysis published in Obesity, directly compared the 3 FDA-approved agents for chronic weight management in nondiabetic adults: liraglutide, semaglutide, and tirzepatide.3 Drawing on 15 phase 3 randomized-controlled trials with 14,059 patients, the analysis found that all 3 agents significantly reduced body weight compared with placebo, but tirzepatide at its maximum tolerated dose produced the greatest reduction, followed by tirzepatide 15 mg and 10 mg, semaglutide 2.4 mg, tirzepatide 5 mg, and liraglutide 3 mg.3 In the primary network meta-analysis of 12 trials with 11,183 participants, semaglutide 2.4 mg reduced body weight by a mean difference of −13.39% versus placebo (95% CI, −15.46 to −11.33). Compared with placebo, semaglutide showed a modest but statistically significant increase in risk of any adverse event (RR, 1.03; 95% CI, 1.00-1.07), similar to tirzepatide, whereas liraglutide did not show a significant increase.3 For serious adverse events specifically, semaglutide 2.4 mg was associated with significantly higher risk than placebo (RR, 1.41; 95% CI, 1.11-1.79), as was liraglutide 3 mg (RR, 1.31; 95% CI, 1.01-1.71); no tirzepatide dose reached statistical significance for serious adverse events.3 The Obesity review's authors noted that "no clinically meaningful differences in adverse event rates were observed among the three FDA-approved agents" with respect to gastrointestinal tolerability, though liraglutide showed a slightly lower risk of diarrhea and constipation compared with semaglutide and tirzepatide.3 Taken together, these 3 analyses reinforce a consistent message for pharmacists counseling patients on GLP-1 RA therapy for weight management: semaglutide delivers substantial, clinically meaningful weight loss, but gastrointestinal adverse events-nausea, vomiting, diarrhea, and constipation-remain the primary driver of early discontinuation.1,2 Because the dose-response data suggest that these adverse events tend to increase most steeply during dose escalation before plateauing, pharmacists are well positioned to counsel patients on anticipated timing of symptoms and reinforce adherence to the gradual titration schedule.2 The Medicine review's authors emphasized that treatment effects reflected in these trials likely represent the combined benefit of pharmacotherapy and concurrent lifestyle intervention, including calorie restriction and increased physical activity, rather than semaglutide alone-reinforcing counseling points around diet and exercise as adjuncts to drug therapy rather than optional add-ons.1 All 3 study teams noted limitations relevant to counseling and formulary considerations. The Medicine authors cited the small number of included trials and relatively short follow-up periods, which limit conclusions about long-term efficacy, safety, and weight regain after treatment discontinuation.1 The International Journal of Obesity authors noted significant heterogeneity in study design, dosing regimens, and follow-up duration. The Obesity review's authors cautioned that most comparisons were indirect, since only 2 of the 15 included trials offered head-to-head data between agents.2,3 GenoHope Biotech Ltd. A leading manufacturer of GLP-1 API Approal by FDA Welcome any Inquiry WhatsApp/Tel:+8613833133635 Email:info@genohopebio.com Send Inquiry