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Novo Nordisk presents four new analyses on oral semaglutide 25 mg (Wegovy® in a pill*) at ObesityWeek® 2025, including demonstrated reductions in cardiovascular risk factors
- Post hoc analyses include data showing investigational oral semaglutide 25 mg use was associated with improvements in blood sugar control and cardiovascular (CV) risk factors across multiple categories of weight loss1
- Another analysis detailed an indirect trial comparison between oral semaglutide 25 mg and the currently available injectable form, showing comparable efficacy2
- In two additional analyses, oral semaglutide 25 mg was associated with the same weight loss efficacy in women with obesity regardless of menopausal stage, and patients reported improvements in physical function, respectively3,4
PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Nov. 5, 2025 /PRNewswire/ – Novo Nordisk today presented new data from the OASIS 4 phase 3 trial that explored a variety of patients and hypotheses, adding to the body of evidence supporting this potential treatment option.1 Four abstracts in total were presented, highlighting a breadth of results with oral semaglutide 25 mg during ObesityWeek® 2025 in Atlanta, GA.
“Novo Nordisk has pioneered innovation in the obesity class for 25 years, and the oral semaglutide data at ObesityWeek® reflect our drive to improve the lives of people living with obesity,” said Martin Holst Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk. “The OASIS 4 results that we are sharing at this important meeting build on existing clinical trial evidence for oral semaglutide and extend findings beyond weight loss to suggested improvements in overall health.”
A cardiometabolic post hoc analysis from the OASIS 4 phase 3 clinical trial examined how the amount of weight patients lost affects glycemic parameters (blood sugar control) and cardiovascular (CV) risk factors in adults with overweight and obesity. In participants with overweight or obesity, once-daily oral semaglutide 25 mg treatment compared with placebo led to greater improvements in glycemic parameters, including HbA1c, fasting plasma glucose, and fasting serum insulin, as well as CV risk factors such as C-reactive protein and serum triglycerides.
Results showed that in the overall trial population, a higher percentage of participants with pre-diabetes at baseline achieved normal blood glucose (sugar) at week 64 in the semaglutide group versus placebo (71.1% versus 33.3%). Participants treated with oral semaglutide 25 mg were more likely to achieve ≥15% body weight reduction, compared with those who received placebo. Within the semaglutide group, more people who achieved ≥15% body weight reduction saw larger improvements than those with <15% weight reduction in systolic (−10.1 mmHg versus −4.1 mmHg, mean change from baseline) and diastolic (−4.3 mmHg versus −1.1 mmHg, mean change from baseline) blood pressure readings. Reductions in levels of inflammatory marker C-reactive protein (0.34 versus 0.74, ratio to baseline) and in lipids (blood fats), including non–high density lipoprotein cholesterol (0.90 versus 0.96, ratio to baseline) and triglycerides (0.73 versus 0.87, ratio to baseline), were also observed. While improvements were observed across measures within the semaglutide group, greater improvements were observed in people who had achieved a ≥15% body weight reduction in the trial.1
“As recently published in The New England Journal of Medicine , the primary results from the OASIS 4 clinical trial demonstrated weight loss efficacy of investigational oral semaglutide 25 mg as a potential therapeutic option for people with obesity and overweight,” said Domenica Rubino, MD, trial investigator and Director, Washington Center for Weight Management and Research in Washington, DC. “It’s exciting to see these new results from the cardiometabolic post hoc analysis, which showed that while benefits were most pronounced in people who achieved greater than 15% weight loss, clear improvements in glycemic parameters and CV risk factors were observed in patients taking oral semaglutide 25 mg, regardless of how much weight was lost, based on the groups observed.”
Additional OASIS 4 data
Indirect comparison between formulations
Data presented from an indirect treatment comparison of the OASIS 4 (oral semaglutide) and STEP 1 (injectable semaglutide) phase 3 clinical trials in adults with obesity and overweight demonstrated that key outcomes — like the share of people reaching ≥5%, ≥10%, ≥15%, ≥20% body weight reductions, positive changes in cardiometabolic markers, and quality of life scores — were comparable for the oral and injectable formulations in these trials, respectively.2Weight reduction by menopause status
A pooled, post hoc analysis of the OASIS 4 and STEP trials showed that regardless of menopause stage, use of semaglutide was associated with significant weight loss. Pre-menopausal women lost an average of 18.2% body weight, while peri-menopausal women lost 15%, and post-menopausal women lost an average of 15.7% body weight over 64 weeks. The percentage of women in the analysis who achieved more than 15% weight loss included: 58.1% (in the pre-menopausal group), 56.5% (in the peri-menopausal group), and 53.4% (in the post-menopausal group). Results were comparable to the weight loss seen in the STEP 1 trial of Wegovy® (semaglutide) injection 2.4 mg.3Patients with obesity and poor physical function
Another post hoc analysis from OASIS 4 showed that people in the semaglutide group who self-reported low physical function (PF) at the start of the trial, as determined by the Patient Global Impressions of Status (PGI−S) questionnaire, saw improvements compared to the overall study population at 64 weeks. A meaningful change in PF score was achieved by most patients (77.3%) taking oral semaglutide 25 mg versus those taking placebo (42.9%).4Exploratory post hoc analyses are hypothesis-generating, and further work investigating the clinical validity of these results would be of value.
The safety and tolerability profile of oral semaglutide 25 mg, as reported in the recently published OASIS 4 study in The New England Journal of Medicine , was consistent with that for injectable Wegovy®.5,6 In the OASIS 4 trial, gastrointestinal adverse events with oral semaglutide 25 mg were generally mild to moderate in severity and transient; the most common of which were nausea (46.6% versus 18.6% for placebo) and vomiting (30.9% versus 5.9% for placebo). Adverse events leading to permanent treatment discontinuation were 6.9% (oral semaglutide 25 mg) and 5.9% (placebo). The incidence of serious adverse events was 3.9% (oral semaglutide 25 mg) and 8.8% (placebo).5 This reinforces the safety and tolerability profile of semaglutide, as also demonstrated in more than 37 million patient-years of exposure.5,6
Oral semaglutide 25 mg (Wegovy® in a pill*) is not FDA approved. In February, Novo Nordisk submitted a New Drug Application (NDA) for the once-daily pill formulation of Wegovy®.7 The FDA review of this NDA is anticipated to be completed by the end of this year.8 Currently, there are no approved oral formulations of a GLP-1 medicine for weight loss.
If approved by the FDA, Wegovy® in a pill will be fully made in the US, with production already underway at Novo Nordisk’s North Carolina manufacturing facilities.
- Tradename of ‘Wegovy® pill’ submitted to the FDA and is pending approval.
** Analyses were conducted under treatment policy and trial product estimands.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.5 People with diabetes were excluded.5 OASIS 4 included a 64-week treatment period, including a 12-week dose escalation, and a 7-week off-treatment follow-up period.5In 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.5
About obesity
Obesity is a serious, chronic, progressive, and complex disease that requires long-term management.9-11 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.9,11 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.12,13About Wegovy®
Injectable semaglutide 2.4 mg is marketed under the brand name Wegovy®. In the EU, Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy® is also indicated for pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy® major adverse cardiovascular events (MACE) risk reduction, improvements in HFpEF-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis.14In the US, Wegovy® (semaglutide) injection 2.4 mg is currently approved along with a reduced calorie diet and increased physical activity, for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off and to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.14 It is important to note that semaglutide injection 2.4 mg contains a Boxed Warning for possible thyroid tumors, including cancer and should not be used in those with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Ai ai ai, her har Novo hatt webcall skjønner jeg 
Bytte kanskje bytta ut CEO med “NovoBot”, en AI-generert CEO? Så man slipper disse klassiske call-duppene?
Dagens låt: Ronan Keating: “(You say it best) when you say nothing at all”
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Mens Lilly er helt ustoppelig om dagen. Nesten som man lurer man har satset på feil hest…
LLY + 17% siste 5 børsdager. Enormt for en blue chip.
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17% for verdens største pharma etter mcap faktisk…
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Da er vi oppe på 318 igjen i US, bakrusen slapp taket
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Amerikanerne er mer glad i aksjen enn danskene ser det ut til. Klokkerent treff på bunn den danske sluttauksjonen
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WSJ rapporterer at Pfizer visstnok tenker å matche Novo høyeste bud… Begynner å bli en dyr miss om pipe’n til Metsera ikke leverer nå.
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Den som går tapende ut av denne budkrigen kommer til å gå etter Viking
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Danskene sender nok en gang kursen ned ift USA.
Er jo gode muligheter for arbitrasje handel. Kjøpe på close i danmark, også selge på åpning dagen etter
PFE kjøper VKTX lett. NVO trenger ikke VK2735 subkutan (tror jeg da), da CagriSema er trolig akkurat like god / dårlig på efficacy & toleranse.
REDEFINE 4 (CagriSema vs. LLYs tirzepatide h2h) skal forsåvidt lese av i q1 2026, og vil gi en pekepinn på hva ståa blir. Målet er vel “non-inferiority”, men NVO håper seff på superiority på et eller annet punkt. NVO venter neppe på dataene fra REDEFINE 3 (CagriSema i CVOT over en millard måneder) som først kommer i 2027 engang, så tipper søknad til FDA går inn med readoutene som kommer i q1.
Det store spørsmålet blir vel om LLYs next gen med /trippelagonisten retatrutide) har kommet med overbevisende resultater før REDEFINE 4 leser av. Det store spørsmålet blir kanskje hvordan CagriSema stacker opp mot retatrutide. Eller for å snu det hele: Leser CagriSema av med 23% vekttap og retatrutide med 24% mens sistnevnte har en haug med bivirkninger så er NVO fort mer “back in the game”. Men hvem f vet. Ikke jeg.
Fase II data fra LLYs eloralintid (amylinanalog) ute nå. Vektnedganger i 10-20% på 48 uker. Novo holder seg greit, men Zealand (som venter fase II data fra petrilintid i h1 2026) stuper nedover.
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LLY skriver i pressemelding at de kicker i gang fase III nå i q4.
NVO starter også en fase III med sin amylinanalog cagrillintid (Cagri i CagriSema) denne q’et.
Så det ble neck to neck i amylin-racet for NVO og LLY. I skrivende stund kan det se ut som om eloralintid er et lite hakk hvassere både på efficacy og toleranse, men erfaring tilsir jo at fase II-data ikke alltid blir like gode fase III-data (også for LLY, host host or-host-for-host-glipron host).
Artikkelen tar for seg hva som skjer når folk som sliter med matinntaket slutter på slankemedisinen. Dvs går opp igjen. Tipper det er mange som må gå på medisinene livet ut.
Big business for Novo m.fl., eller motsatt, at staten(e) ikke er villige til å betale for uendelige kurer?
Jeg tenker pharma-selskapene senker prisen nok til at staten(e) er villige til å betale og tar det igjen ved å utvide kundegrunnlaget massivt (må stå på medisinen livet ut).
Mange allerede som driver og “mikrodoserer” seg selv som vedlikeholdsterapi, også her til lands. Altså de setter mindre doser på seg selv enn produsenten anbefaler. Så blir det billigere, varer lenger, og man unngår appetitten som forårsaker vektøkning igjen.
Etter hvert vil det nok komme rene “vedlikeholdsmedikamenter”, altså medisiner som ikke har til formål å forårsake vekttap, men bare vektvedlikehold. Jeg har gjetta (et par ganger) at det vil bli amylin-analoger. (Litt) lavere efficacy, men bedre toleranse enn glp1s over hele fjøla. Og klart, senker man dosene dit at man bare skal oppnå å unngå vektøkning, så blir toleransen enda bedre for disse amylinanalogene. Metsara (som PFE og NVO begge vil kjøpe) har en månedlig subkutan amylinanalog på vei. Structure (GCPR) starter en fase I med en ikke-peptid amylinanalog pille.
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Det ender vel nesten garantert i pilleform til slutt, i hvert fall for vedlikeholdsbiten…
For vekttapsbiten, så kan det være at fordelene med sprøyte er såpass stor at det fortsetter.
Altså, for en utenforstående, så virker det nesten som om det bare er å kjøpe topp tre el topp fem på vekttap og så holde dem? Markedet er gigantisk og det er jo rimelig sannsynlig at en av disse vil være vinneren.
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Deal med trumpen?