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Novos oral semagutid leverer 16,65% vægttab i studie


128465 Helge Larsen/PI-redaktør 18/9 2025 06:50
Oversigt

Novo Nordisk's oral semaglutide 25 mg (Wegovy® in a pill*) delivered 16.6% weight loss in people with obesity in a newly published study

Oral semaglutide 25 mg (the once-daily pill formulation of Wegovy®) achieved significant weight loss, with one in three study participants losing 20% or more body weight1**
Oral semaglutide 25 mg also demonstrated improvements in the ability to perform everyday physical activities such as bending, standing, walking, being physically active, and improvements in cardiovascular risk factors1
Oral semaglutide 25 mg is the first oral GLP-1 therapy submitted to the US Food and Drug Administration (FDA) for chronic weight management,2 and Novo Nordisk has already begun production at its US sites

Bagsværd, Denmark, Plainsboro, NJ, 17 September 2025 - Today, The New England Journal of Medicine published the results from the OASIS 4 phase 3 trial that studied the efficacy and safety of the investigational once-daily oral semaglutide 25 mg (Wegovy® in a pill*), marking a significant milestone in the company's ambition to advance obesity care. In the 64-week trial, oral semaglutide 25 mg, alongside lifestyle modifications, was compared to placebo in 307 adults with obesity or overweight with one or more weight-related comorbidities, without diabetes.1

Results showed that if all participants adhered to treatment, average weight loss of 16.6% was achieved by people taking oral semaglutide 25 mg compared to 2.7% for placebo at 64 weeks, with over a third (34.4%) experiencing a weight loss of 20% or more, versus 2.9% for placebo.1**
This was comparable with previous trial results of injectable Wegovy®.3

When looking at the effect regardless of whether the participants took the medicine exactly as they should, people taking oral semaglutide 25 mg still achieved an average weight loss of 13.6% versus 2.2% with the placebo.1*** Close to a third (29.7%) had a weight loss of 20% or more versus 3.3% for placebo.1*** Additionally, the study also found that oral semaglutide 25 mg improved cardiovascular risk factors, as well as the ability to be more active in daily life, compared to placebo. This was consistent with previous trial results of injectable Wegovy®.1,3

"The oral semaglutide 25 mg data show compelling efficacy for an oral weight management medication with 16.6% weight loss and a safety and tolerability profile consistent with injectable Wegovy®," said Martin Holst Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk. "Currently, less than 2% of individuals with obesity in the US receive obesity medication and Wegovy® in a pill may also address patient preference for oral treatment. Pending FDA approval, ample supply will be available to meet the expected US demand as we hope to set a new treatment benchmark for oral weight loss medications for people with overweight or obesity."

The safety and tolerability profile of oral semaglutide was consistent with that for injectable Wegovy®.1,3 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).1 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).1 This reinforces the safety and tolerability profile of semaglutide, as also demonstrated in more than 37 million patient-years of exposure.1,4

"The OASIS 4 trial results further underscore the significant impact that semaglutide can have in achieving sustainable weight loss and broader health benefits," said Sean Wharton, lead study author and medical director of the Wharton Medical Clinic. "Oral semaglutide 25 mg builds on the proven efficacy and established safety and tolerability profile of semaglutide and represents a significant advancement in obesity treatment. People with overweight or obesity have individual preferences, and with oral semaglutide as a potential new treatment option, more of those who are not on treatment today may consider starting GLP-1 treatment."

In February, Novo Nordisk submitted a New Drug Application (NDA) for the once-daily pill formulation of Wegovy®.2* The FDA review of this NDA is anticipated to be completed by the end of this year.5 Currently, there are no approved oral formulations of a GLP-1 medicine for weight loss.

If approved by the FDA, the pill for weight management will be fully made in the US, with production already underway at Novo Nordisk's significantly expanded manufacturing facility.

* Tradename of 'Wegovy® pill' submitted to the FDA and is pending approval.
** Based on the trial product estimand: estimated treatment effect if all participants adhered to treatment.
*** Based on the treatment policy estimand: treatment effect regardless of treatment adherence.

About OASIS 4
OASIS 4 was a 64-week phase 3 randomised, 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 randomised in a 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, alongside lifestyle intervention for 64 weeks.1

About obesity
Obesity is a serious, chronic, progressive, and complex disease that requires long-term management.6-8 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.6,8 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.9,10

About 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 paediatric 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.10

In 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.11 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).

Oral semaglutide 25 mg (Wegovy® in a pill*) is not approved in the US or in Europe.


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 78,400 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
Media:
Ambre James-Brown
+45 3079 9289
[email protected]

Liz Skrbkova (US)
+1 609 917 0632
[email protected]

Læs hele pressemeddelelsen:

https://ml-eu.globenewswire.com/Resource/Download/78e7deb7-f802-4a57-a8a4-088df77736fb



18/9 2025 07:03 ProInvestorNEWS 3128466



FINANCIAL TIMES (FT.COM)

NOVOS WEGOVY-PILLE TÆT PÅ AT MATCHE DEN INJICERBARE VERSION I VÆGTTABSFORSØG

Novo Nordisks antifedmepille giver næsten lige så meget vægttab som den Wegovy-injicerbare. Det viser et nyt forsøg i den danske medicinalproducent kamp mod ærkerivalen Eli Lilly på markedet for en tabletversion af vægttabsmidlet. Patienter tabte 16,6 pct. af deres kropsvægt i løbet af et 64-ugers fase 3-forsøg, lige under de 17 pct., som patienter, der tog injektionen. En ud af tre deltagere, der tog piller, tabte 20 pct. af deres kropsvægt. (NOVO'S WEGOVY PILL CLOSE TO MATCHING INJECTABLE VERSION IN WEIGHT-LOSS TRIAL)

Marketwire



18/9 2025 07:17 ProInvestorNEWS 3128469



Novo : Flere gode data får aktien til at stige til 380 DKK https://proinvestor.com/boards/128468



18/9 2025 07:28 bb8 5128471



Hehe, det er faktisk mere end for den dobbelte dosis 50mg i OASIS-1. Godt resultat. Jeg ville have nævnt bivirkninger i pressemeddelelsen, hvis de er bedre for den halve dosis. Det skal nærstuderes.

Lilly kom (desværre for os Novo-aktionærer) med disse nyheder:

ATTAIN-1
Lilly's oral GLP-1, orforglipron, demonstrated meaningful weight loss and cardiometabolic improvements in complete ATTAIN-1 results published in The New England Journal of Medicine
https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-meaningful-weight

Jeg har vedhæftet figur fra NEJM-artiklen vedrørende ATTAIN-1.

ACHIEVE-3
Lilly's oral GLP-1, orforglipron, superior to oral semaglutide in head-to-head trial
https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-superior-oral-semaglutide-head

Bemærk, at det er 7mg og 14mg semaglutid og 12mg og 36mg orforglipron i ACHIEVE-3. 14mg og 12mg lidt mere sammenlignelige, men orforglipron stadig bedre på HbA1C og vægttab.

Novo har godt nok den orale serve-ret, men Lilly kommer med deres SMD nok til at tage første sæt, som jeg ser det.

NOVO B.CO




18/9 2025 07:29 ProInvestorNEWS 5128473



Novo præsenterer nye lovende data for Wegovy-pille - GENT
i dag kl. 06:34 ∙ MarketWire

Novo Nordisk er godt på vej med et nyt produkt, der kan øge antallet af patienter, der bliver behandlet for svær overvægt med et af medicinalkoncernens lægemidler.

Det danske selskab har sent onsdag aften præsenteret data fra et forsøg med Semaglutid - det aktive stof i Wegovy og Ozempic - på tabletform.

Dataene viser, at forsøgspersonerne i gennemsnit tabte 16,6 pct. af deres vægt i løbet af de 64 uger, som forsøget varede.

34 pct. af dem opnåede endda et vægttab på 20 pct. eller mere.

Det er resultater, der ligger meget tæt op ad dem, man har opnået med injicerbar semaglutid, også når det gælder bivirkninger.

I dag har Novo kun tilladelse til at tilbyde Semaglutid som injektionspenne, der skal tages én gang ugentligt.

Men selskabet har allerede i februar i år ansøgt de amerikanske sundhedsmyndigheder om lov til at tilbyde tabletbaseret semaglutid og håber at få et positivt svar senere i år.

Sker det, vil man allerede i begyndelsen af 2026 kunne levere Wegovy i tabletform til amerikanske patienter.

På den måde vil patienterne kunne vælge mellem, om de helst vil stikke sig selv en gang om ugen eller spise en pille en gang om dagen.

Når vi får godkendelsen, vil der være tilstrækkelige forsyninger til at imødekomme den forventede efterspørgsel, og vi håber at sætte en ny standard for oral vægttabsmedicin til personer med overvægt eller fedme, siger Martin Holst Lange, der er forskningschef hos Novo Nordisk.

Novo Nordisk har siden 2019 haft tilladelse til at markedsføre semaglutid i pilleform til behandling af diabetes 2. Det er sket under varemærket Rybelsus.

Konkurrenten Eli Lilly er også på vej med en vægttabspille baseret på et stof, der er i familie med semaglutid.

Selskabet offentliggjorde onsdag resultater fra et forsøg med lægemidlet Orforglipron i pilleform, der også skal indtages én gang dagligt.

Det viste et gennemsnitligt vægttab på 12,4 pct. ved den højeste dosis, samtidig med at der også blev konstateret forbedringer, hvad angår blodtryk og kolesterolniveau.

/ritzau/



18/9 2025 07:35 bb8 5128475



Nå, bivirkninger var faktisk nævnt i pressemeddelelsen. Jeg må have stavet forkert, da jeg søgte efter det.

"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)."

Jeg kan ikke på stående fod huske de samme tal for 50mg. Men rigtig fine tal for 25mg.



18/9 2025 07:31 bb8 5128474



Her forresten link til NEJM-artiklen vedrørende ATTAIN-1:
Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment
https://www.nejm.org/doi/full/10.1056/NEJMoa2511774



18/9 2025 07:43 bb8 6128476



Novo Nordisk's oral semaglutide 25 mg (Wegovy® in a pill*) delivered 16.6% weight loss in people with obesity in a newly published study
https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916428

Novo Nordisk Fireside Chat
17/9/2025 18:30 CET
https://edge.media-server.com/mmc/p/boyxgi4o/

Hvis nogen lytter til telekonferencen, så må I meget gerne skrive om det herinde. Jeg får først tid til at lytte i weekenden.



18/9 2025 12:26 epelis 5128478



Der er absolut en del spændende at hente i relation til NNs kliniske program for næste år.
Burde vi ikke alle have kendskab til denne type fireside chat via NN. Genmab annoncerer altid disse chats.



19/9 2025 20:08 bb8 1128495



Til dem der ikke gider bruge en time paa at lytte til fireside chat, saa har jeg en god nyhed. Transcript kan findes her:
https://seekingalpha.com/article/4823802-novo-nordisk-as-nvo-r-and-d-investor-event-call-transcript

Der var dog ikke noget nyt under solen, som ikke allerede var blevet annonceret ved EASD2025 eller i pressemeddelelser denne uge. Men interessant for mig at hoere, hvordan Martin Holst Lange ser paa kagrilinitid (09:01 inde i videoen) og har fokus paa bivirkninger:

"We see obesity as a complex disease, a disease where individual patients have individual needs. And just to give you an example, if you have BMI of 30, a 25% weight loss will get you to a BMI of 22, and that is maybe not what patients want. Maybe that patient would like to have 12% weight loss with fewer side effects. And we know from REDEFINE 1 that cagrilintide monotherapy gives exactly that 12% weight loss, at least in that study and approximately half of the gastrointestinal side effects that we saw with the GLP-1 analogs."

---

Novo-chef tæt på at afsløre hemmelig plan
https://borsen.dk/nyheder/virksomheder/novo-chef-taet-pa-at-afslore-hemmelig-plan

Forskningsdirektør var tæt på at tale over sig under investormøde
https://medwatch.dk/strategi/article18553340.ece

Jeg har ikke abonnement paa Boersen, saa jeg ved ikke, hvad Boersen mener, at CSO var taet paa at afsloere. Er det bare en click-bait-overskrift?

"So exciting times ahead. And at the same time, with my new job and new title. I'm obviously also focused very much on building the research pipeline and portfolio. And I was about to say something I was not supposed to say. But in the not so distant future, you will hear more about what we plan to do with the research pipeline and how we progress that."



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