Wegovy (semaglutide injection once weekly) / Novo Nordisk, Emcure - LARVOL DELTA

Novo Nordisk A/S: More efficacious dose of Wegovy recommended by the European Medicines Agency can help people with obesity achieve an average of 20.7% weight loss (GlobeNewswire) - "The positive opinion is based on the results from the STEP UP and STEP UP T2D clinical trial programme in people with obesity with and without type 2 diabetes....Novo Nordisk has also applied to the EMA for a single-dose device to deliver Wegovy 7.2 mg. Additionally, semaglutide 7.2 mg is currently under review in the US, UK and several other countries."

CHMP • Obesity • Type 2 Diabetes Mellitus

Waiting on Atrial Fibrillation Intervention Therapy (WAIT) Study (clinicaltrials.gov) - P4 | N=200 | Not yet recruiting | Sponsor: Emma Svennberg

New P4 trial • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Genetic Disorders • Obesity

Regulator releases new safety warnings for weight loss and diabetes drugs including Ozempic, Wegovy and Mounjaro (News.com.au) - "The safety alert issued by the regulator on Monday details links to two separate safety issues; the potential risk of suicidal thoughts, and reduced effectiveness of oral contraception...It relates to GLP-1 and dual GIP/GLP-1 receptor agonists which are primarily prescribed to manage type 2 diabetes and obesity, and are marketed in Australia as Ozempic (semaglutide) Wegovy (semaglutide), Saxenda (liraglutide), Trulicity (dulaglutide) and Mounjaro (tirzepatide)."

Non-US regulatory • Obesity • Type 2 Diabetes Mellitus

Online telehealth company Hims and Hers Health HIMS.N is launching its weight-loss membership and treatment plans in the UK which will include drugs like Novo Nordisk's NOVOb.CO Wegovy… (The Independent) - "The drug will be available at a starting price of £149 a month for a year commitment."

Commercial • Obesity

Slimmer price tag helps Wegovy sales gain weight (The Economic Times) - "With a near-40% price cut, Novo Nordisk has finally broken the cost barrier for Wegovy, which had struggled to gain traction in India's market for weight-loss drugs. The discount, announced last month, is already showing results in increased adoption as Wegovy's sales volume surged 70% in November within about 20 days of the price cut, signalling immediate consumer response to the lower price."

Sales • Obesity

WHO releases its first guidelines on GLP-1s (The Hill) - "The WHO’s guidelines stated GLP-1s may be used for the long-term treatment of obesity in adults, excluding pregnant women. This recommendation is 'conditional' as there is currently 'limited data on their long-term efficacy and safety'....The guidelines specifically applied to three GLP-1 medications: liraglutide, semaglutide and tirzepatide. Semaglutide and tirzepatide are perhaps the most well-known GLP-1s in the U.S., sold commercially as Wegovy and Zepbound respectively when prescribed for weight management. Liraglutide is sold commercially as Saxenda in the U.S."

Clinical guideline • Obesity

Phoenix NP Expands Access to FDA-Approved Weight Loss Medications Across Arizona (The Manila Times) - "Phoenix NP emphasized that public confusion surrounding medication options has increased as some clinics continue to promote compounded versions despite the updated federal guidelines. The organization noted that this expansion aims to provide women throughout Phoenix, Scottsdale, Tempe, Chandler, Gilbert, and Goodyear with a clear and reliable source for FDA-approved treatments, dispensed directly from NovoCare and Lilly Direct."

Commercial • Obesity

As next-generation anti-obesity drugs are being developed one after another, the obesity drug market is expected to be reshaped next year, centering on so-called "oral Mounjaro" and "high-dose Wegovy." (The Asia Business Daily)

Launch non-US • Obesity

GLIMMER: Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass (clinicaltrials.gov) - P=N/A | N=25 | Not yet recruiting | Sponsor: University of Alberta

New trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight (clinicaltrials.gov) - P3 | N=460 | Not yet recruiting | Sponsor: Novo Nordisk A/S

Monotherapy • New P3 trial • Genetic Disorders • Obesity

A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo (clinicaltrials.gov) - P2 | N=626 | Completed | Sponsor: Novo Nordisk A/S | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Diabetes • Genetic Disorders • Metabolic Disorders • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus • CST3

Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected) (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

The new, higher dose of Wegovy (semaglutide 7.2 mg) is currently under review with the European Medicines Agency (EMA), in the UK and several other countries. In the EU, Novo Nordisk expects a regulatory decision in Q1 2026. (Novo Nordisk Press Release)

EMA approval • Obesity

Novo Nordisk files for FDA approval of a higher dose of Wegovy injection 7.2 mg (Novo Nordisk Press Release) - "Under the CNPV expedited program, review is expected within 1–2 months following the FDA's acceptance of the filing...The sNDA includes results from STEP UP, a 72-week phase 3, randomized, double-blind, placebo-controlled and active-controlled superiority trial that evaluated the efficacy and safety of once-weekly semaglutide 7.2 mg compared to placebo and semaglutide 2.4 mg, as an adjunct to lifestyle intervention, in 1,407 adults with obesity (BMI ≥30 kg/m2)."

FDA filing • Obesity

Phase III Clinical Study Comparing the Efficacy and Safety of GZR18 Injection and Semaglutide (Wegovy®) in Adult Obese or Overweight Subjects (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: Gan & Lee Pharmaceuticals. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Medicare announces price cuts for…prescription drugs, including Ozempic (MSN News) - "The Centers for Medicare and Medicaid Services on Tuesday announced lower prices on 15 costly prescription drugs under Medicare, including Ozempic and Wegovy....Ozempic, Rybelsus and Wegovy, for Type 2 diabetes and weight loss: $274 negotiated price, down from the $959 list price. (Negotiated prices for higher doses of Wegovy are $385.)."

Commercial • Obesity • Type 2 Diabetes Mellitus

Mounjaro Surpasses Wegovy in New Obesity Drug Prescriptions (Business Korea) - "According to an obesity drug prescription data as of October submitted by the Health Insurance Review and Assessment Service to Rep. Kim Yoon of the Democratic Party of Korea, who serves on the National Assembly Health and Welfare Committee, prescriptions for Mounjaro’s lowest dose of 2.5mg reached 32,050 cases, approximately 2.7 times higher than Wegovy’s lowest dose prescriptions of 0.25mg (11,843 cases)....Changes in prescription preferences are also being detected in the prescription numbers by dosage for both products."

Commercial • Obesity

Dutch healthcare institute could add 2 more obesity medicines to basic health insurance (NL Times) - "The National Healthcare Institute is looking into adding another two obesity medications to the basic health insurance package. These are Wegovy and Mounjaro."

Reimbursement • Obesity

Xevant Expands Ivim at Work and Introduces New Lower Pricing on Wegovy and Ozempic for Employers Nationwide (Businesswire) - "The update introduces pricing starting at $199 per month for the first two doses of Wegovy and Ozempic (0.25 mg and 0.5 mg) for new patients, followed by a standard continuation price of $349 per month for continued therapy with Wegovy and Ozempic. All pricing reflects U.S. pharmacy supply and full clinical oversight through the Ivim at Work program. The changes strengthen Xevant’s position as a leader in enabling evidence-based weight-loss therapy at the lowest viable cost for employer health plans."

Pricing • Obesity

LifeMD…announced a new, lower cash-pay price for GLP-1 medications, Wegovy and Ozempic, made possible through its ongoing collaboration with Novo Nordisk (GlobeNewswire) - "LifeMD will now offer the 0.25 mg and 0.5 mg doses at $199 per month-the lowest cash-pay pricing available nationwide-for two fills for new patients. The offering is designed to support patients who pay out of pocket....This update follows recent national efforts to improve affordability and access to GLP-1 therapies, including initiatives led by the White House and leading pharmaceutical manufacturers such as Novo Nordisk and Eli Lilly."

Commercial • Diabetes • Obesity

Novo Nordisk today announced that Wegovy (semaglutide) injection 0.25 mg and 0.5 mg and Ozempic are now available at a limited time price of $199 per month to new self-pay patients between now and March 31, 2026. (PRNewswire) - "This introductory offer is good for the first two months of therapy and applies to the two lowest doses (0.25 mg and 0.5 mg) of Wegovy or Ozempic. After those two months, patients will move to the new standard monthly self-pay price which Novo Nordisk is lowering from $499 to $349 per month, also beginning today....These self-pay offers can be accessed in multiple ways: Directly through wegovy.com or ozempic.com...NovoCare Pharmacy...Other participating organizations and select telehealth providers that work directly with Novo Nordisk, such as Costco, GoodRx, WeightWatchers, Ro, LifeMD, and eMed....For patients with commercial insurance coverage who qualify, Novo Nordisk continues to offer savings programs that allow them to pay as little as $0 per month for Wegovy or $25 per month for Ozempic."

Pricing • Chronic Kidney Disease • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk's Wegovy (semaglutide 2.4 mg) was associated with liver health-related benefits not solely based on weight loss in adult patients with MASH with liver scarring, according to a new post hoc analysis (Novo Nordisk Press Release) - "An additional secondary analysis found that semaglutide 2.4 mg, when compared to placebo, showed improvements in both liver injury and in liver scarring across various ages, genders, races, and ethnicities...Steatohepatitis-related NITs improved in all groups receiving semaglutide 2.4 mg, with the greatest treatment effect observed for alanine aminotransaminase (ALT) in patients with weight loss of ≤7%. In this subgroup, patients receiving semaglutide 2.4 mg showed a greater mean absolute change in ALT from baseline to Week 72 when compared to those receiving placebo (ETR 0.75, 95% CI 0.68, 0.82)...In this subgroup, 48.4% of patients receiving semaglutide 2.4 mg showed improvement in the resolution of the liver injury endpoint compared to 25.8% of patients receiving placebo (EDP 21.7, 95% CI 4.9, 38.4)....Part 2 of the ESSENCE trial will continue with expected readout in 2029."

P3 data • Metabolic Dysfunction-Associated Steatohepatitis

Chinese doctors call for insurance coverage for weight-loss drugs (The Standard) - "The government introduced its first set of guidelines last year to standardise the diagnosis and treatment of obesity. Yet it does not plan to include weight-loss drugs in the national medical insurance scheme, instead directing funds elsewhere...However, calls to subsidise weight-loss drugs in a field where professionals are usually reluctant to be associated with public campaigns highlight the risk that weight-related problems pose to the healthcare system...A year's supply of a weight management drug from one drugmaker can cost up to 35,040 yuan ($4,919), a Reuters calculation showed. That is equivalent to about 50% of the average annual wage of urban private-sector employees last year....The National Healthcare Security Administration did not respond to a request for comment."

Reimbursement • Obesity

Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medications Affect the Amount of Food Left in the Stomach in People Using Liraglutide (Injected), Semaglutide (Taken by Mouth) or Semaglutide (Injected) (clinicaltrials.gov) - P1 | N=75 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Genetic Disorders • Obesity

Mangoceuticals Partners with Eli Lilly and Novo Nordisk to Deliver Affordable Access to Zepbound and Wegovy for Obesity Management (GlobeNewswire) - "These branded GLP-1 medications will be made available to both MangoRx and PeachesRx customers via Eli Lilly’s LillyDirect Self Pay Pharmacy Solutions and Novo Nordisk’s NovoCare Pharmacy. Through MangoRx and PeachesRx’s secure telehealth platform, customers will receive virtual consultations with board-certified providers, personalized obesity and weight management treatment plans, ongoing clinical monitoring and support, and to the extent eligible, fulfillment of these U.S. Food and Drug Administration (FDA)-approved GLP-1 medications via partner pharmacies or through their neighborhood pharmacies of choice."

Commercial • Obesity