RegulationAccelerated Approval (United States), Breakthrough Therapy (China), Commissioner's National Priority Voucher (United States), Conditional marketing approval (United States), Priority Review (United States)

Structure/Sequence

Sequence Code 50953

Source: *****

581

Clinical Trials associated with Semaglutide (Novo Nordisk)

NCT07179120

/ Not yet recruitingPhase 2IIT

Male Fertility Preservation: Efficacy Evaluation of GLP-1Receptor Agonist Therapy for Infertility in Obese Males - A Multicenter Clinical Randomized Controlled Trial

Why is this study being done? Obesity can harm men's fertility by lowering sperm quality and hormone levels, making it harder to have children. Weight loss through diet and exercise helps, but it's often hard to stick with. New medicines called GLP-1 receptor agonists, like semaglutide (Ozempic) and tirzepatide (Mounjaro), help people lose weight and improve health. Early studies suggest these drugs might also boost sperm health in obese men, but more proof is needed. This study tests if these drugs can safely improve fertility in obese men who are having trouble conceiving.
What will happen in this study?
This is a 48-week study at several hospitals in China. About 180 men will be randomly assigned to one of three groups:
Group 1: Standard lifestyle changes, like a healthy diet and exercise, guided by experts.
Group 2: Weekly injections of semaglutide, starting low and increasing as tolerated.
Group 3: Weekly injections of tirzepatide, starting low and increasing as tolerated.
All men will have regular check-ups, including blood tests, semen analysis, and weight measurements. We will track sperm quality, hormone levels, weight loss, and whether their partners get pregnant naturally. The study includes an 8-week adjustment period, 24 weeks of treatment, and 16 weeks of follow-up.
Who can join this study? Men aged 20-45 who are married, obese (BMI 28 or higher or waist size 90 cm or more), and have been trying to have a baby for at least a year without success due to low sperm count or poor sperm movement. Their female partners must be under 40 and have no major fertility issues. Men must be willing to attend visits and provide samples. People with serious health problems, recent use of similar drugs, or other causes of infertility (like genetic issues) cannot join.
How long will this study last? The full study lasts 48 weeks (about 11 months), with visits every 4-8 weeks, plus monthly phone check-ins for pregnancy updates.
What are the possible benefits and risks? Benefits: If the drugs work, men may lose weight, improve sperm quality, and have a better chance of their partners getting pregnant naturally. They might also feel healthier overall. Risks: Common side effects include nausea, vomiting, or diarrhea from the drugs, which usually improve over time. Rare risks include pancreas inflammation or gallbladder issues. Lifestyle changes might cause minor injuries from exercise. All side effects will be monitored closely, and participants can quit anytime. Insurance covers any study-related harm.

Start Date01 May 2026

Sponsor / Collaborator

The First Affiliated Hospital of Wenzhou Medical College

NCT07021937

/ Not yet recruitingPhase 3IIT

Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial

Glucagon-like peptide 1 receptor agonists (GLP-1RA), such as Ozempic and Wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. However, despite this rapid adoption and the known GLP-1RA mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. The goal of the current study is to compare youth and adults with obesity who are treated a GLP-1RA and measure potential difference in GLP-1RA associated change in brain function, appetite, and eating behaviors.

Start Date01 May 2026

Sponsor / Collaborator

University of Colorado Denver

[+1]

NCT07090343

/ Not yet recruitingPhase 3IIT

Semaglutide for Reducing Cardiovascular Events in Patients Undergoing Transcatether Aortic Valve Replacement

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the safety and efficacy of once-weekly semaglutide 2.4 mg in adult patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) who meet current clinical criteria for semaglutide treatment. A total of 826 participants will be randomized 1:1 to receive semaglutide or placebo as an add-on to standard-of-care, starting 3 months before TAVR and continuing for 24 months post-procedure. The primary endpoint is time to first occurrence of a composite of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke or transient ischemic accident (TIA), and hospitalization for heart failure (HF). The study is event-driven and powered to detect a 20% relative risk reduction in primary outcome events. This trial aims to address the unmet need for medical therapies that improve outcomes in patients with severe AS following TAVR, with potential for direct clinical implementation.

Start Date01 Apr 2026

Sponsor / Collaborator

Leids Universitair Medisch Centrum

100 Clinical Results associated with Semaglutide (Novo Nordisk)

100 Translational Medicine associated with Semaglutide (Novo Nordisk)

100 Patents (Medical) associated with Semaglutide (Novo Nordisk)

315

Literatures (Medical) associated with Semaglutide (Novo Nordisk)

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of semaglutide in people with obesity and cardiovascular disease without diabetes

Article

Author: Lübker, Christopher ; Lincoff, A. Michael ; Bøg, Martin ; Lingvay, Ildiko ; McEwan, Phil ; Toliver, Joshua C. ; Yeates, Florian ; Faurby, Mads ; Miller, Ryan ; Foos, Volker

AIMS:

The cardioprotective effects of semaglutide 2.4 mg reported in the SELECT cardiovascular (CV) outcomes trial (ClinicalTrials.gov NCT03574597) provide clinical benefit for subjects with overweight or obesity and established CV disease without type 2 diabetes (T2D). We assessed cost-effectiveness of semaglutide 2.4 mg in this population against the American College of Cardiology/American Heart Association value framework.

MATERIALS AND METHODS:

A cohort-level Markov-state cost-effectiveness model using trial-derived data with outcomes from a healthcare sector perspective measured over a lifetime horizon was developed. Treatment costs were based on US list prices; scenario analyses used literature-reported estimated rebates. Healthcare costs and benefits were discounted at 3.0%. A simulated cohort of 100,000 subjects was aligned to the SELECT trial population baseline characteristics and time-on-treatment. Subjects received either semaglutide 2.4 mg or placebo in addition to standard of care (SoC). Modelled outcomes included clinical events (CV events, progression to T2D, chronic kidney disease [CKD]) and health economic measures, including direct costs and quality-adjusted life years (QALYs).

RESULTS:

Mean semaglutide 2.4 mg treatment duration was 2.79 years. Per 100,000 subjects, treatment avoided 2,791 non-fatal myocardial infarctions, 3,000 coronary revascularizations, 487 non-fatal strokes, and 115 CV deaths over the modeled lifetime horizon. Average per-subject lifetime treatment costs were $47,353; savings arose from avoided T2D ($14,431), CKD ($2,074), and CV events ($1,512). Semaglutide 2.4 mg was associated with increased lifetime costs ($29,767), additional QALYs gained (0.218) and an incremental cost-effectiveness ratio of $136,271/QALY at list price; a scenario using an empirically estimated 48% rebate predicted $32,219/QALY.

LIMITATIONS:

The generalizability of observations from SELECT to a broader US population is unknown. Our model does not capture all outcomes nor costs that may be affected by weight loss. Modeling assumptions may present limitations.

CONCLUSIONS:

Semaglutide 2.4 mg use as in SELECT is cost-effective at list price, using a $150,000/QALY willingness-to-pay threshold.

01 Dec 2025·SOCIAL SCIENCE & MEDICINE

Even with diet and exercise, Ozempic use reduces perceived effort and praiseworthiness of resulting weight loss

Article

Author: Savulescu, Julian ; Dranseika, Vilius ; Devolder, Katrien ; Hannikainen, Ivar ; Brown, Rebecca C H ; Earp, Brian D ; Ryan, Nanette ; Bachmakova, Maria ; Buyukbabani, Mey Bahar ; Everett, Jim A C

The injectable medication Ozempic (semaglutide) has demonstrated unprecedented effectiveness in promoting significant weight loss. However, its use has sparked moral debates, with critics dismissing it as a mere "shortcut" compared to traditional methods like diet and exercise. This study investigates how weight loss method-Ozempic, diet/exercise, or a combination of both-impacts perceptions of effort, praiseworthiness, and identity/value change. We used a contrastive vignette technique in two experiments (combined N = 1041, demographically representative for age, sex, and ethnicity) to study the attitudes of US participants toward a fictional character who lost 50 pounds through one of the three described methods. Weight loss through diet/exercise alone was deemed most effortful and most praiseworthy, whereas Ozempic use, even when combined with diet/exercise, was rated as both less effortful and less praiseworthy than diet/exercise alone. Ozempic use with no mention of diet/exercise was rated as least effortful and least praiseworthy. Compared to diet and exercise alone, Ozempic use also decreased perceptions that the individual had really changed as a person, or experienced a change in their underlying values. We discuss potential implications, address study limitations, and provide suggestions for further work.

01 Dec 2025·NEUROPHARMACOLOGY

GLP-1 receptor agonist semaglutide ameliorates motor deficits and tau pathology in the rTg4510s mouse model

Article

Author: Li, Xin-Yi ; Liu, Feng-Tao ; Xu, Zhi-Heng ; Lin, Hua-Mei ; Zhang, Meng-Wei ; Chen, Chen ; Zuo, Chuan-Tao ; Wu, Jian-Jun ; Zhao, Jue ; Wang, Jian ; Yu, Wen-Bo ; Tang, Yi-Lin ; Zhou, Wan-Yi ; Sun, Yi-Min

BACKGROUND:

Tauopathies, including Alzheimer's disease, are characterized by progressive neurodegeneration manifesting as motor and cognitive impairments. This study evaluated the therapeutic potential of semaglutide, a clinically approved glucagon-like peptide-1 receptor agonist, in the rTg4510 mouse model of tauopathy.

METHODS:

Starting at three months of age, rTg4510 mice and wild-type littermates received semaglutide (0.10 mg kg^-1, intraperitoneal) or vehicle (PBS) every other day for 16 weeks. Motor coordination, anxiety-like behavior, spatial working memory, and associative fear memory were assessed using behavioral paradigms. Tau accumulation was monitored via 18F-PM-PBB3 micro-PET/CT imaging. Immunohistochemistry and immunoblot analyses quantified tau pathology, neuronal integrity, and glial activation.

RESULTS:

Semaglutide significantly improved motor coordination in rTg4510 mice on the pole test, though not rotarod endurance. While spontaneous locomotion, anxiety-like behaviors, and Y-maze spatial working memory remained unchanged, semaglutide significantly enhanced cue-dependent freezing in fear conditioning, indicating improved associative memory. ¹⁸F-PM-PBB3 PET imaging revealed a pronounced reduction in cortical and hippocampal tracer uptake, indicative of reduced tau burden. Immunohistochemistry and Western blotting confirmed significantly decreased cortical phosphorylated tau (AT8) levels. Semaglutide preserved cortical neuronal integrity; however, no hippocampal changes were detected, likely due to minimal baseline neuron loss at this age. Astrocytic (GFAP) and microglial (Iba1) activation remained unaffected.

CONCLUSION:

Semaglutide ameliorated domain-specific motor impairments, enhanced associative fear memory, and attenuated cortical tau pathology in rTg4510 mice. These findings highlight therapeutic promise of semaglutide as a disease-modifying agent for tauopathies, justifying further dose-response, mechanistic, and translational studies.

2,542

News (Medical) associated with Semaglutide (Novo Nordisk)

23 Dec 2025

·www.biospace.com

Novo’s Wegovy Pill Wins Obesity Approval, Securing Lead in Oral GLP-1 Race

iStock, choi dongsu Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market. The FDA has approved Novo Nordisk’s Wegovy pill for weight management, making the product the first oral GLP-1 treatment for people who are overweight or have obesity in the U.S. Novo’s pill contains 25 mg of semaglutide, the GLP-1 receptor agonist found in the injectable version of Wegovy and its diabetes-indicated sibling Ozempic. The FDA approved the product based on data including a Phase III trial that linked the Wegovy pill to 16.6% mean weight loss. Patients lost similar amounts of weight on the once-daily oral and once-weekly injectable formulations of Wegovy. BMO Capital Markets analysts said in a note to investors that the approval is “a much-needed win in light of recent challenges maintaining incretin market share dominance.” Having initially led the GLP-1 market, Novo has lost ground amid competition from injectables sold by Eli Lilly and compounding pharmacies. The oral launch, which is set for early January, again establishes Novo as the first entrant to a potentially lucrative market. “Novo will likely benefit from first-mover advantage, capturing patients with a preference for convenience and comfort provided by an oral dosing regimen,” BMO analysts said. Yet Novo may have a short window in which to capitalize on its first-mover advantage. Lilly has filed for FDA approval of its oral GLP-1 candidate orforglipron and has a Commissioner’s National Priority Voucher that could accelerate regulatory review. Ilya Yuffa, president of Lilly USA, said at a Citi conference this month that the company expects to launch orforglipron early in the second quarter of 2026. GLP-1 A Compounding Problem: How GLP-1s Drove Novo Nordisk’s Rapid Rise and Fall Novo Nordisk has plummeted back to Earth after a stunning rise driven by Ozempic and Wegovy. Can the storied Danish pharma recover? August 13, 2025 · 5 min read · Nick Paul Taylor Read More This suggests Novo may have just a few months to establish a foothold in the oral GLP-1 market before facing competition. Average weight loss on orforglipron in a Phase III trial was 12.4%, compared to 13.7% on injectable Wegovy, according to results released in August. Lilly’s shares initially fell 7% in response to the data, although analysts have since become more bullish in their expectations for orforglipron. BMO analysts see orforglipron and other oral GLP-1 candidates as threats to the Wegovy pill. The analysts said the Wegovy pill’s food effect, which prevents patients from eating, drinking or taking other oral medications for 30 minutes after dosing, “is likely to limit uptake upon approval of orforglipron and other orals with more convenient pro ” The analysts expect investors to focus on Wegovy pill sales in 2026, “especially early in the launch when no true competition exists.” BMO’s team named data from a head-to-head trial of Novo’s CagriSema and Eli Lilly’s tirzepatide, the active ingredient in Mounjaro and Zepbound, expected in early 2026, as another focus of investor interest. Many investors expect Novo’s drug combination, which is under review at the FDA, to match tirzepatide, the analysts said. With noninferiority the baseline expectation, there is scope for perceptions of Novo to improve if CagriSema can beat tirzepatide. Yet BMO analysts said they are cautious because early CagriSema results have underperformed most expectations.

Phase 3Clinical ResultDrug Approval

22 Dec 2025

·www.prnewswire.com

FDA approves Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults

Average weight loss of ~17% if all patients stayed on treatment* with Wegovy® (semaglutide) tablets 25 mg (~14% regardless of if patients stayed on treatment**) in the OASIS 4 trial1 1.5 mg starting dose available in early January for $149 per month with savings offers; Wegovy® pill is being produced in the US and robust supply is on-hand Wegovy® brand is the only GLP-1 indicated for weight loss proven to help prevent life-threatening CV events for adults with established CVD and either overweight or obesity along with diet and exercise; Wegovy® has been prescribed for approximately 3.2 million people in the US2-4 PLAINSBORO, N.J., Dec. 22, 2025 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved once-daily Wegovy® pill, the first oral GLP-1 medicine for obesity in the US.3 Wegovy® pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off.3 Wegovy® pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with overweight or obesity and established cardiovascular disease.3 "The launch of Wegovy® in 2021 changed how obesity was viewed and treated in the US. Now, with Wegovy® pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials. We are confident that the expansion of Wegovy® to a pill will help patients who may have not sought or accepted treatment before," said Dave Moore, executive vice president, US Operations at Novo Nordisk. "Wegovy® pill is the next chapter in our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity. We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities." The FDA approval of Wegovy® pill is based on the results from the OASIS 4 phase 3 clinical trial, which was a 64-week medical study that included 307 adults with obesity or overweight with one or more weight-related comorbidities, without diabetes.1 Results showed that if all patients stayed on treatment, people taking Wegovy® pill once-daily along with a reduced calorie diet and exercise achieved an average weight loss of about 17% (16.6%) versus about 3% (2.7%) with placebo.*1 When looking at the efficacy regardless of if all patients stayed on treatment, an average weight loss of about 14% (13.6%) was achieved by people taking Wegovy® pill compared to about 2% (2.4%) for placebo.**1 In OASIS 4, common adverse reactions were similar to those previously seen in clinical trials with Wegovy® (semaglutide) injection 2.4 mg, including nausea, diarrhea, and vomiting.1 "With more choices, HCPs are better equipped to tailor treatment approaches and support patients who want to gain control of their weight, and this milestone approval underscores exactly that kind of choice," explained Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. "The availability of Wegovy® pill expands the possibilities for weight management with semaglutide, giving healthcare professionals a powerful, efficacious medicine in a new method of delivery, allowing the ability to help meet more patients where they are." The starting dose of 1.5 mg will be available in pharmacies and select telehealth providers in early January with savings offers for just $149 per month. Additional information on coverage and savings options for eligible patients, including other programs designed to help reduce out-of-pocket costs, will also be available at that time. "After many years advocating for people living with obesity, one thing has always been clear: patient safety has to come first. That's why it's critical we rely on treatments that are rigorously tested and FDA-approved," said Joe Nadglowski, president and CEO of the Obesity Action Coalition. "A brand new effective pill for weight loss gives people greater flexibility to choose a GLP-1 treatment that can fit in their daily routine and preferences." Wegovy ® pill is only approved in the US. Novo Nordisk expects to launch Wegovy® pill in early January 2026. * Based on the trial product estimand: estimated efficacy in an idealized scenario in which all patients stayed on treatment and took no other weight loss therapies. ** Based on the treatment policy estimand: treatment effect regardless of if patients stayed on treatment or took other weight loss therapies. About OASIS 4 OASIS 4 was a 64-week phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with one or more weight-related comorbidities.1 People with diabetes were excluded.1 OASIS 4 included a 64-week treatment period, including a 12-week dose escalation, and a 7-week off-treatment follow-up period.1 In total, 307 participants were randomized in a 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, alongside lifestyle intervention for 64 weeks.1 For those taking Wegovy® pill, 76% achieved 5% or greater body weight loss (from a baseline body weight of 235 lb.) versus 31% taking placebo (from a baseline body weight of 231 lb.).1 About obesity Obesity is a serious, chronic, progressive, and complex disease that requires long-term management.5-7 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.5,7 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.8,9 What is Wegovy®? Wegovy ® (semaglutide) injection 1.7 mg or 2.4 mg and Wegovy ® (semaglutide) tablets 25 mg are prescription medicines used with a reduced calorie diet and increased physical activity to: reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight. help adults with obesity, or some adults with excess weight (overweight) who also have weight-related medical problems to lose weight and keep the weight off. Wegovy® (semaglutide) injection 1.7 mg or 2.4 mg is used with a reduced-calorie diet and increased physical activity to help children 12 years and older with obesity to lose weight and keep the weight off Wegovy ® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines. It is not known if Wegovy® injection is safe and effective: to reduce the risk of major cardiovascular events (death, heart attack, or stroke) in people under 18 years to help children under 12 years of age lose weight and keep the weight off It is not known if Wegovy® tablets are safe and effective for use in people under 18 years of age. Important Safety Information What is the most important information I should know about Wegovy ® ? Wegovy ® may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy ® and medicines that work like Wegovy ® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy ® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people Do not use Wegovy ® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use Wegovy ® if: you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy ® injection or Wegovy® tablets. See symptoms of serious allergic reaction in "What are the possible side effects of Wegovy® ?" Before using Wegovy ® , tell your healthcare provider if you have any other medical conditions, including if you: have or have had problems with your pancreas or kidneys have type 2 diabetes and a history of diabetic retinopathy have or have had depression, suicidal thoughts, or mental health issues are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation) are pregnant or plan to become pregnant. Wegovy ® may harm your unborn baby. You should stop using Wegovy ® 2 months before you plan to become pregnant are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Wegovy® tablets. It is not known if Wegovy ® when received through an injection passes into your breast milk Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy ® may affect the way some medicines work and some medicines may affect the way Wegovy ® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy ® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. What are the possible side effects of Wegovy ® ? Wegovy ® may cause serious side effects, including: inflammation of your pancreas (pancreatitis). Stop using Wegovy ® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back gallbladder problems. Wegovy ® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy ®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy®. Tell your healthcare provider if you have stomach problems that are severe or will not go away serious allergic reactions. Stop using Wegovy ® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy ® increased heart rate. Wegovy ® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy® before you are scheduled to have surgery or other procedures The most common side effects of Wegovy ® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat. Please click here for Prescribing Information including Boxed Warning and Medication Guide for Wegovy®. About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X. Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com. References: Wharton S, Lingvay I, Bogdanski P, et al. Oral semaglutide 25 mg in adults with overweight or obesity. N Engl J Med. 2025; 393:1077-1087. DOI: 10.1056/NEJMoa2500969. Novo Nordisk A/S. Data on file. Wegovy® (semaglutide) Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; 2025. Lincoff MA, Brown-Frandson K, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389:2221-2232. 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. Obes 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: December 2025. Available at: . Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: December 2025. Available at: . © 2025 Novo Nordisk All rights reserved. US25SEMO02580 December 2025 SOURCE NOVO NORDISK INC. 21% more press release views with Request a Demo

Clinical ResultPhase 3Drug Approval

19 Dec 2025

·firstwordpharma.com

Altimmune touts new data for MASH hopeful, but investors sour

Altimmune said Friday that its experimental drug pemvidutide continued to improve key non-invasive markers of fibrosis through 48 weeks in a mid-stage trial of patients with metabolic dysfunction-associated steatohepatitis (MASH), extending signals first seen at six months and clearing the way for Phase III testing next year.The Phase IIb IMPACT trial randomised 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes to receive either a 1.2 mg or 1.8 mg weekly subcutaneous dose of pemvidutide, or placeboAt the 24-week mark, the dual GLP-1/glucagon receptor agonist met one of the co-primary endpoints, achieving statistically significant rates of MASH resolution without worsening fibrosis versus placebo, but fell short on the other measure of fibrosis improvement without worsening of MASH. Those results, reported in June, put a serious dent in the company's stock.Investors still waryAnd it appears investors were not quite persuaded this time around either: after jumping in premarket trading on Friday, Altimmune shares were down more than 25% shortly after markets opened.The new 48-week data showed that patients on pemvidutide achieved significant improvements versus placebo in Enhanced Liver Fibrosis (ELF) scores and Liver Stiffness Measurement (LSM), with continued reductions from the 24-week timepoint. Specifically, mean ELF scores fell by 0.49 and 0.58 in the 1.2-mg and 1.8-mg arms, respectively, compared with a rise of 0.16 for placebo, while LSM declined by up to 3.97 kPa with pemvidutide. Additionally, roughly a third of patients on the higher dose achieved both a ≥0.5 reduction in ELF and a 30% drop in liver stiffness, versus just over 3% for placebo.Altimmune also reported significant improvements on other measures of liver health and hepatic inflammation, including reductions in liver fat content, ALT and corrected T1, alongside additional weight loss. Patients on the 1.8-mg dose lost 7.5% of body weight at 48 weeks, extending an earlier decline of 6.2% seen in the June readout, with "no evidence of plateauing," the company said.Safety remained consistent with earlier data, with treatment-related discontinuations of 0% and 1.2% in the low- and high-dose groups, compared to 3.5% for placebo, and no treatment-related serious adverse events.Hope for Phase IIIThe company said it recently completed a "productive" end-of-Phase II meeting with the FDA and aligned on parameters for a registrational Phase III trial in MASH patients with moderate-to-advanced fibrosis that it plans to start in 2026. Moreover, it said regulators were also receptive to its proposal to incorporate AIM-MASH AI Assist, a newly qualified AI tool intended to standardise histologic assessment to help reduce time and resources needed for MASH drug development.Despite the negative investor reaction following the June readout, some analysts are optimistic about the drug's prospects. In a note last month, Citizens JMP suggested pemvidutide's fibrosis response "was one of the best we have seen," given it was measured only after 24 weeks, while the placebo response was "one of the highest" they had seen. "The fibrotic effect was cooperated by multiple non-invasive fibrosis markers and AI pathology, and we fully expect pemvidutide to hit on fibrosis in a larger, longer Phase III. We also note both [Madrigal Pharmaceuticals'] Rezdiffra (resmetirom) and [Novo Nordisk's] Wegovy (semaglutide) missed statistically on fibrosis in their Phase II trials before hitting in Phase III."

Phase 2Clinical ResultPhase 3

100 Deals associated with Semaglutide (Novo Nordisk)

External Link

KEGG	Wiki	ATC	Drug Bank
D10025	Semaglutide (Novo Nordisk)	A10BJ06	DB13928

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fibrosis, Liver	United States	Novo Nordisk, Inc.	22 Dec 2025
Pulmonary Fibrosis	Canada	Novo Nordisk Canada, Inc.	21 Dec 2025
Cardiovascular Diseases	United States	Novo Nordisk, Inc.	15 Aug 2025
Metabolic Dysfunction Associated Steatohepatitis	United States	Novo Nordisk A/S	15 Aug 2025
Metabolic Dysfunction Associated Steatohepatitis	United States	Novo Nordisk, Inc.	15 Aug 2025
Chronic Kidney Diseases	United States	Novo Nordisk, Inc.	28 Jan 2025
Chronic Kidney Diseases	United States	Novo Nordisk A/S	28 Jan 2025
Stroke	Australia	Novo Nordisk Pharmaceuticals Pty Ltd.	16 Dec 2024
Myocardial Infarction	Canada	Novo Nordisk Canada, Inc.	27 Nov 2024
Obesity	United States	Novo Nordisk, Inc.	04 Jun 2021
Overweight	United States	Novo Nordisk, Inc.	04 Jun 2021
Diabetes Mellitus, Type 2	United States	Novo Nordisk, Inc.	05 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Albuminuria	Phase 3	Canada	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Germany	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Netherlands	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	Spain	Novo Nordisk A/S	14 Mar 2022
Osteoarthritis, Knee	Phase 3	United States	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Canada	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Colombia	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Denmark	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	France	Novo Nordisk A/S	01 Oct 2021
Osteoarthritis, Knee	Phase 3	Norway	Novo Nordisk A/S	01 Oct 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03574597 (SELECT, Pubmed \| J Med Econ)	Phase 3	Cardiovascular Diseases \| Obesity	-	Semaglutide 2.4 mg	gwybmtytnt(chxfdulecy) = mcxncirlud ckzpgemawq (okbwfdlrir ) View more	Positive	31 Dec 2025
NCT04892199 (Pubmed \| JAMA Psychiatry)	Phase 2	Schizophrenia	73	Semaglutide 1 mg	bbaeptnvfk(dmxhdhenjw) = rmgdthsbil ugbspaqspp (crldkyanwh )	Positive	03 Dec 2025
NCT04971785 (WAYFIND, CTgov)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis \| Fibrosis \| Compensated cirrhosis	457	Semaglutide (SEMA)+Cilofexor (CILO)/Firsocostat (FIR) (SEMA + CILO/FIR FDC)	etqsyvnalm = fnxumhdtki fagsglabsw (hbbkaeddpc, awyfskmbmg - zftetxlxpv) View more	-	26 Nov 2025
				PTM SEMA+PTM CILO/FIR (PTM SEMA + PTM CILO/FIR)	etqsyvnalm = uigxkahpiv fagsglabsw (hbbkaeddpc, ttrwzbusra - wjudaapvko) View more
NCT03919929 (TEAL, CTgov)	Phase 2/3	Polycystic Ovary Syndrome \| Metabolic dysfunction-associated steatotic liver disease \| Pediatric Obesity	60	Weight loss diet (Diet Intervention)	negmreyxpr(eoboapdjrj) = auufmqstki lygfhwbapu (mdnnwbjafc, 2.24) View more	-	25 Nov 2025
				Semaglutide 3mg and 7mg [Rybelsus] (GLP-1 Intervention)	negmreyxpr(eoboapdjrj) = gubiqcnwgy lygfhwbapu (mdnnwbjafc, 4.39) View more
NCT04777409 (EVOKE Plus \| EVOKE+, Company_Website \| NEWS) Manual	Phase 3	Alzheimer Disease	1,953	Semaglutide	omvoffnalt(laznfcuuit) = did not confirm superiority of semaglutide versus placebo in the reduction of progression of Alzheimer’s disease amgbmfjhnl (cqjtokbvzj )	Negative	24 Nov 2025
				Placebo
NCT04777396 (EVOKE, Company_Website \| NEWS) Manual	Phase 3	Alzheimer Disease	1,855	semaglutide	fcjnulgnvx(dqsmnrpnck) = did not confirm superiority of semaglutide versus placebo in the reduction of progression of Alzheimer’s disease oepxlgyrtf (kngiagqddc )	Negative	24 Nov 2025
				Placebo
NCT05205928 (SEMA-AP, ASN2025) Manual	Not Applicable	Diabetes Mellitus, Type 1	22	Semaglutide	wqrskctqsx(tkwiimjqqf) = korjcpcupy qjocukkjzz (tavshpwpfy, -23.2 to -6.5) View more	Positive	06 Nov 2025
				Placebo	wqrskctqsx(tkwiimjqqf) = dazvovsonl qjocukkjzz (tavshpwpfy, -20.0 to -1.3) View more
NCT05193578 (Pubmed \| JAMA Psychiatry)	Phase 3	Schizophrenia	154	Semaglutide	eqvcsstlyg(osyxgofduj) = agljqzkhyh tdlvzgxsus (wqqiyylpbl, 1.52 - 5.98) View more	Positive	01 Nov 2025
NCT04916470 (STEP-HFpEF DM, Pubmed \| JACC Heart Fail)	Phase 3	-	1,145	Semaglutide	kzaxosdabm(cahurmesfp): Difference (Semaglutide vs Placebo) = 14.6 (95.0% CI, 8.6 - 20.7), P-Value = < 0.0001 View more	Positive	01 Nov 2025
				Placebo
NCT04019197 (Pubmed \| Clin Infect Dis)	Phase 2	HIV Infections	108	Semaglutide	arfmvujtdt(khndjvfemh): P-Value = 0.04 View more	Positive	16 Oct 2025
				Placebo

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