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Novo Nordisk

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#464

Novo Nordisk presents phase 3 data for next-generation amylin cagrilintide, leading to advancement into dedicated clinical programme

2025-09-16 12:00:47

  • Positive results show that the average weight loss was 12.5 kg (11.8% body weight reduction) with cagrilintide compared to 2.5 kg (2.3%) with placebo, after 68 weeks*1,2
  • Cagrilintide was well-tolerated, with the most common side effects being gastrointestinal; these were mainly transient and mild to moderate in severity1
  • Based on these results, Novo Nordisk will advance cagrilintide into the dedicated RENEW phase 3 clinical programme later this year

Bagsværd, Denmark, 16 September 2025 – Novo Nordisk today presented data from a sub-analysis of the phase 3 REDEFINE 1 trial at the European Association for the Study of Diabetes (EASD) congress 2025 from 15–19 September in Vienna, Austria. This sub-analysis evaluated the efficacy and safety of once-weekly cagrilintide 2.4 mg monotherapy, plus lifestyle intervention, for adults with obesity or overweight and a weight‑related comorbidity without diabetes.1 Cagrilintide is a long-acting amylin analogue that mimics the naturally occurring hormone amylin and works differently than currently approved GLP-1-based treatments for weight loss.1,2 These findings represent the first and only phase 3 clinical trial data with an investigational long-acting amylin analogue monotherapy for the management of obesity.1

In REDEFINE 1, cagrilintide provided clinically meaningful weight loss, with an average body weight reduction of 11.8% compared to 2.3% with placebo after 68 weeks, if all participants adhered to treatment.*1 Additionally, around 1 in 3 participants (31.6%) receiving cagrilintide achieved ≥15% weight loss, compared to around 1 in 20 participants (4.7%) receiving placebo.*1,2

Cagrilintide was well-tolerated, with the most common side effects being gastrointestinal, including nausea, vomiting, diarrhoea and constipation. These were mainly temporary and mild to moderate. Nausea led to permanent discontinuation of cagrilintide in 1.0% of participants, compared with 0.1% of participants for placebo.1 “These data highlight the exciting potential of cagrilintide to offer an alternative approach for people to lose weight, achieve health-related outcomes and manage their obesity, including a favourable tolerability profile,” said lead investigator Timothy Garvey, MD, professor of medicine and director of the Diabetes Research Center at the University of Alabama at Birmingham. “Like other chronic diseases, we need a range of treatment options to address the individual needs of people with obesity, such as their own specific response to treatment.”

When evaluating the treatment effect regardless of adherence,** average weight loss with cagrilintide was 11.5% compared to 3.0% with placebo after 68 weeks. Additionally, 31.0% of participants achieved ≥15% weight loss with cagrilintide compared to 5.2% with placebo.**1

The dedicated phase 3 RENEW programme will investigate the efficacy and safety of cagrilintide in people with obesity or overweight and is due to start in Q4 2025.

“Our current and future therapies aim to help people with obesity achieve meaningful weight loss and broader health benefits. With the global scale of obesity, further scientific innovation and therapy options are needed to meet every individual’s needs and preferences,” said Martin Holst Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk. “In our clinical trials, cagrilintide has provided substantial weight loss, in a distinct manner compared to approved obesity medications, and appears well-tolerated. We’re excited that these data, the first phase 3 data of a next-generation amylin therapy, show promise and we look forward to further investigating cagrilintide’s potential in the dedicated phase 3 RENEW programme.”

  • 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.

Ser teknisk spennende ut igjen

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#465

Har skrevet om amylinanaloger som mulig vedlikeholdsterapi i fedmebehandlingstråden tidligere. Såpass bra toleranse som dette (man kan jo sammenligne med kvalme-ratene til orforglipron + vk2735 og discontinuations der om man vil se spennet…) betyr to ting:

a) kommer til å fungere skikkelig bra som vedlikeholdsterapi alene (de som har vært på CagriSema har allerede tolererbarhet, og man skal ikke se bort i fra det at de som ev. kommer fra amycretin vil ha noe av det samme, selv om det er alt alt for tidlig å si noe vettig om akkurat det).

b) som Zealand-boss Adam? Lange sier: Kvaliteten på vekttapet vil for mange i framtiden bety mer enn kvantiteten. For å parafrasere ham: Vil man miste 12-13% vekt og ha det ganske trivelig i perioden man holder på, eller vil man miste 15% vekt og ha det mer eller mindre for jævlig? Ser at andre begynner å bevege seg i den retninga også, hørte en call her med Structure, og der ble akkurat det samme framhevet: Prosentene på vekttapet vil være underordnet tolererbarhet (Structure har bare ikke-peptide tabletter i pipe btw, kommer fase IIb-data nå for aleniglipron i q4, skal prøve å få skrevet litt om hele caset i fedme-tråden før data kommer )

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#466

FDA strammer endelig inn for compounders. Dette er good news for Novo, not so good for billigvariantene.

https://www.investors.com/news/technology/hims-stock-fda-warning-letter-compounded-semaglutide/

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#467

Så, det de blir tatt på er reklamen?

On its website, Hims claims its compounded product uses the “same active ingredient as Ozempic and Wegovy,” which Novo sells as treatments for type 2 diabetes and obesity. The compounded drug uses “clinically proven ingredients,” the agency said.

“Compounded drug products are not FDA-approved,” the letter said. “Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded.”

De kan ikke nevne Ozempic og Wegovy, fordi hvis produktet deres hadde vært det samme, så hadde det vært en ulovlig kopi.

1 Like
#468

og NOVO mottok nesten samme advarsel :sweat_smile:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novo-nordisk-inc-716495-09092025

Legger inn advarselen HIMS fikk:

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hims-hers-health-inc-dba-hers-09092025

#469

Det er da ikke det samme i det hele tatt?

NOVO fikk advarsel fordi de ikke legger nok vekt på bivirkningene i reklamen, mens HIMS får advarsel fordi de sier implisitt at compound-drugen de reklamerer for er FDA-approved. Noe den ikke er.

NOVO:

FDA recommended revising the draft promotional communication to avoid omitting material risk information regarding the risk of MTC and thyroid tumors, and warnings and precautions associated with gastrointestinal side effects and hypoglycemia

HIMS

The following claims concerning your compounded semaglutide products appear on your website:
• “Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy”
• “Clinically proven ingredients”

Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].

Problemet for NOVO er nok at dette gjør det lettere for de som evt har fått større bivirkninger å saksøke NOVO.

3 Likes
#470

Upresist av meg, begge fikk advarsel for å være " false or misleading" men på forskjellig grunnlag

#471

NOVO kan rette på reklamen sin. HIMS, vel, hva kan de gjøre? De har ingen forskning e.l. å støtte seg på såvidt jeg vet. De har basically ingenting?

#472

De kan vel også bare forandre på teksten på hjemmesiden, når det kommer til salget så lener de seg forsatt på at de tilbyr mindre doser til folk som har bivirkinger som NOVO ikke tilbyr . Men dette er komplisert

#473

Problemet er hva er det de skal markedsføre?

#474

Tror de står fritt til å bare kalle det Semaglutide API

#475

Så forresten på Bloomberg her at Novo planlegger å søke FDA om godkjenning av 7,2 mg sema (3x godkjent dose i dag). Martin Lange sa i går noe sånn som at “de andre selskapene [les: LLY] har optimert sine doser, det gjør vi nå også”. 7.2mg-dosen av Semaglutid vil nesten helt garantert klarere FDA. Og greia er at når den gjør det, så sitter NVO med en subkutant levert legemiddel, som egentlig mer eller mindre matcher tirzepatide i efficacy og tolererbarhet.

De lave dosene som compounders tilbyr tror jeg vil bli utkonkurrert av billige piller som orforglipron. Tipper prisene kommer til å matche ganske greit. Vært inne på temaet før, altså “turistklassen” i fedmemarkedet. Lave doser sc vil kanskje ha noe bedre tolererbarhet enn piller, men efficacy vil ikke være bedre.

#476

Men de kan ikke referere til hva effekten er? Siden deres versjon ikke har blitt kjørt gjennom FDA-testingen?

#477

Altså, for å forklare hva greia er med ikke-peptide small molecules: Dette er fra callen til Structure Therapeutics (GPCR) hos Morgan Stanleys 23rd Annual Global Healthcare Conference:

“With small molecules, right now today at Structure Therapeutics, we have the ability to make 6,000 metric tons. What is – what exactly does that mean in terms of patients? We can make enough material today to supply the needs of 100 million patients at 120-milligram dose.”

GPCR er et “jallabio” med MCAP på 1,1 millard USD. Legemidlet de har som er lengst fremme i pipe er aleniglipron som altså er i et par fase IIb’er som leser av nå i q4. Så kan man jo bare tenke seg hva produksjonskapasitet hos en gigant som LLY for orforglipron faktisk må være.

#478

https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-superior-oral-semaglutide-head

1 Like
Fedmebehandling som investering
#479

NVO gjennomførte en spkalt “fireside chat” ved EASD i går. Ennå ikke noe tilgjengelig transcript fra den, men noen slides har blitt lagt ut. Sakser ut den kanskje mest vesentlige av dem alle:

Skjermbilde 2025-09-17 kl. 21.58.19
Skjermbilde 2025-09-17 kl. 21.58.192063×1116 283 KB

Litt rar header på sliden. Burde kanskje ikke stå bare “2026”, men kanskje “litt inn i 2026”. Punkt 1, 2, 4, 5 + fase III-resultat i Alzheimers er ihvertfall guidet 2025, selv om siste kanskje kan gli inn tidlig 2026. Er noe add-on greier på de trialene, så selv om de egentlig avsluttes nå i september, så skulle pasienter følges ut oktober elns.

REDEFINE-4 er h2h CagriSema vs. Tirzepatide. Etter hva jeg kan finne så er den uten den jalla flexiprotokollen som REDEFINE-1 hadde. CagriSema har fått et dårligere rykte enn fortjent (pga idiotisk guiding fra NVO på efficacy), og burde ihvertfall klare målet om “non-inferiority”. Jeg tipper resultatet vil ende på 2-2,5% bedre efficacy enn tirzepatide. Så blir det store spørsmålet når alle pas. er “tvunget” til å ta 2.4 mg (cagri) og 2.4mg (sema), altså maksdosen fra REDEFINE-1, hvordan blir tolerability? Mener REDEFINE-4 “egentlig” hadde trial completion i august 2025, så data derfra kan komme ramlende fortere enn man tror.

2 Likes
#480

Firesidechat’en kan høres her:

https://edge.media-server.com/mmc/p/boyxgi4o

Denne kom også igår kveld:

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.

4 Likes
#481

Lukter “the ultimate comeback kid” av Novo om dagen, det meste går i deres favør.

4 Likes
#482

Novo Nordisk A/S: Ozempic® reduces the risk of heart attack, stroke and death by 23% compared to dulaglutide in the first head-to-head real-world study

  • Ozempic® (once-weekly injectable semaglutide) was associated with a 23% reduced risk of heart attack, stroke and death in people with type 2 diabetes and cardiovascular disease on Medicare versus dulaglutide1
  • Data also highlighted Ozempic® was associated with a 26% lower risk of death versus dulaglutide1
  • This study is the first to directly compare these glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications in everyday real-life use. It fills a significant gap in understanding their effects on heart health in older people at high risk, which could help support informed treatment decisions and health policies.1

Bagsværd, Denmark, 18 September 2025 – Novo Nordisk today announced results from the REACH real-world study, which demonstrated that compared to dulaglutide, Ozempic® (once-weekly injectable semaglutide) was associated with a reduced risk of major adverse cardiovascular events such as a heart attack or stroke by 23%1. The data span nearly 60,000 US Medicare patients (aged ≥66 years) living with type 2 diabetes, atherosclerotic cardiovascular disease (ASCVD) – a condition where fatty deposits build up in blood vessels, reducing blood flow and increasing the risk of heart attacks, strokes and related problems – and multiple health conditions2. The results were presented at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting on 15–19 September in Vienna, Austria1.

“As we age, the risk of experiencing a heart attack, stroke or dying from a cardiovascular event increases. At the same time, there are limited clinical data for people living with diabetes and cardiovascular disease aged 66 years or older. These data, showing a 23% risk reduction of a heart attack, stroke and death, fill an important gap and reinforce the well-established clinical evidence of semaglutide,” said Filip Krag Knop, senior vice president and incoming chief medical officer at Novo Nordisk. “This is great news for older patients as well as healthcare professionals, as these results build on the importance of our randomised clinical trial data assessing the effectiveness of treatments in a real-life setting. This also supports what we already know from our clinical development programmes that not all GLP-1 RAs are the same.”

Beyond these essential benefits, once-weekly semaglutide was also associated with a 25% risk reduction of heart attack, stroke, hospitalisation for unstable angina or heart failure, and death from any cause (five-point MACE)1.
Ozempic® is the only GLP-1 RA that has proven risk reduction of cardiovascular and kidney events in people with type 2 diabetes3-6. These results provide the first direct comparison of cardiovascular outcomes between Ozempic® and dulaglutide in US Medicare beneficiaries and add to the body of evidence for Ozempic®.

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#483

29/9 deadlinen til DJT og “Most Favoured Nations”-opplegget hans vedr. medisinpriser nærmer seg btw. Risikoavers som jeg er har jeg skalert litt (midlertidig) ned, selv om jeg samtidig antar at Novos internasjonale tilfang innebærer at selskapet ikke blir det mest skadelidende BP’et om det skulle bli en del støy rundt dette.

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