Women on blockbuster weight loss drugs warned to use effective contraception
Pregnant women should not take weight loss drugs, the UK's medicines regulator warned amid concerns that people are using the so-called 'skinny jabs' in unsafe ways.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) also said women should not take weight loss drugs if they are breastfeeding or trying to get pregnant, because there isn't enough safety data to know whether the medicine could affect their baby.
'Anyone who gets pregnant while using them should speak to their healthcare professional and stop the medicine as soon as possible,' the agency said.
Meanwhile, all women taking the jabs should ensure they are using a form of contraception that works, the MHRA said.
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One of the drugs, Mounjaro, may make birth control pills less effective, so the agency says women taking the jab should also use a non-oral form of contraception, like an implant or intrauterine device (IUD).
'Obesity reduces fertility in women. So, women with obesity taking GLP-1 drugs are more likely to get pregnant than before they lost weight,' Dr Channa Jayasena, a reproductive endocrinology researcher at Imperial College London, said in a statement.
'Women are advised to do all they can to prevent pregnancy while taking [these] drugs,' Jayasena added.
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In the UK, women already receive these warnings when they get their prescriptions for the blockbuster jabs, which include Ozempic, Wegovy, Saxenda, and Victoza as well as Mounjaro.
The drugs, known as GLP-1 receptor agonists, work by mimicking hormones that help regulate appetites and make people feel full for longer. They have been approved to treat type 2 diabetes and obesity.
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But the MHRA issued the reminder Thursday due to concerns that the drugs' growing popularity means women are buying them illegally online or at beauty salons, without seeing a doctor.
'Skinny jabs are medicines licensed to treat specific medical conditions and should not be used as aesthetic or cosmetic treatments,' Dr Alison Cave, MHRA's chief safety officer, said in a statement.
'They are not a quick fix to lose weight and have not been assessed to be safe when used in this way,' she added.
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Yahoo
38 minutes ago
- Yahoo
Wave Life Sciences Announces Oral Presentation of Preclinical Data Supporting WVE-007's Mechanism (INHBE) to Reduce Fat, Preserve Muscle, and Induce Healthy Weight Loss at ADA's Annual Scientific Sessions
Presentation to highlight WVE-007 (INHBE GalNAc-siRNA) as a potential novel and unique obesity treatment leading to healthy weight loss and supporting preclinical data demonstrating potent and durable reduction in Activin E resulting in fat loss with muscle preservation New preclinical data demonstrate that a single dose of INHBE siRNA leads to lower inflammation of adipose tissue with strong suppression of pro-inflammatory M1 macrophages in visceral fat in DIO mice, highlighting potential mechanistic insights into the risk reduction for type 2 diabetes (T2D) and coronary artery disease (CAD) suggested by human genetics CAMBRIDGE, Mass., June 20, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced the presentation of preclinical data supporting WVE-007, its GalNAc-siRNA designed to silence INHBE mRNA, an obesity target with strong evidence from human genetics. The data demonstrate the ability of Wave's long-acting GalNAc-siRNA to reduce INHBE mRNA and Activin E protein, induce weight loss mainly through reduction of fat mass, and reduce pro-inflammatory macrophage recruitment in a diet-induced obese (DIO) mouse model. The data were highlighted today in an oral presentation at the American Diabetes Association's 85th Annual Scientific Sessions, taking place June 20 to 23, in Chicago. 'These exciting preclinical data highlighted in today's presentation both recapitulate human genetics findings and continue to support the potential of WVE-007 to drive weight reduction by reducing Activin E to induce lipolysis – or fat breakdown, preferentially reducing visceral fat, and decreasing inflammation of adipose tissue – all without impacting lean muscle mass. These data suggest a highly differentiated therapeutic profile with lower visceral fat, less insulin resistance and less inflammation, supporting potential for risk reduction of T2D, CAD and other obesity-related co-morbidities,' said Erik Ingelsson, MD, PhD, Chief Scientific Officer. 'Silencing of INHBE is an entirely orthogonal mechanism from GLP-1s, which are centrally acting and impact the digestive system and central nervous system to decrease appetite. If these preclinical data translate in the clinic, WVE-007 has the potential to transform the obesity treatment paradigm by delivering healthy weight loss, preservation of muscle mass, and infrequent dosing of once or twice a year. We are evaluating WVE-007 in our ongoing INLIGHT clinical trial in adults living with overweight or obesity, and we are on track to deliver the first clinical data in the second half of this year.' Human genetics provides strong evidence for INHBE as a therapeutic target. Individuals who have a protective loss-of-function variant in one copy of the INHBE gene have a healthier cardiometabolic profile, including less abdominal fat, lower triglycerides, and lower risk of type 2 diabetes and cardiovascular disease. These heterozygous carriers also exhibit favorable associations with liver traits, including reductions in cT1 (reflecting liver inflammation and fibrosis) and ALT (reflecting liver damage), with no impact on liver fat. The oral presentation titled, 'siRNA-INHBE Silencing in Mice Recapitulates Human Genetic Data and Demonstrates Improved Healthy Weight Loss Profile,' highlighted results from studies in DIO mice that evaluated monotherapy (INHBE-siRNA alone) as well as combination (INHBE siRNA and semaglutide), and maintenance (INHBE siRNA when semaglutide treatment is discontinued) treatment settings. Key results are as follows: A single dose of INHBE-siRNA led to robust target engagement, including reduction of INHBE mRNA and Activin E protein, a lipolysis suppressor that is upregulated in obesity. Liver INHBE mRNA was strongly correlated with serum Activin E levels following INHBE-siRNA treatment. A single dose of INHBE-siRNA led to weight loss on par with semaglutide. There was a decrease in diet-induced visceral adipose mass and shrinkage of adipocytes compared with PBS treatment, supporting the restoration of healthy adipose tissue with this mechanism of action. Muscle mass was preserved. Infiltration of activated macrophages in visceral adipose was significantly decreased by a single dose of INHBE-siRNA compared with PBS controls. INHBE-siRNA also significantly reduced proinflammatory M1 macrophage (CD11c positive) recruitment while sustaining levels of anti-inflammatory M2 macrophages in visceral fat, indicating an overall shift away from a pro-inflammatory state. When administered as an add-on to semaglutide, a single dose of INHBE-siRNA doubled the amount of weight loss, highlighting potential for combination treatment. Wave's INHBE siRNA curtailed rebound weight gain when semaglutide treatment was discontinued, highlighting its potential as an off-ramp and maintenance treatment following GLP-1 treatment. The full presentation can be accessed by visiting 'Scientific Presentations' on the Investors section of the Wave Life Sciences website: About Wave Life SciencesWave Life Sciences (Nasdaq: WVE) is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Wave's RNA medicines platform, PRISM®, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and common disorders. Its toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing Wave with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Wave's diversified pipeline includes clinical programs in Alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy, Huntington's disease, and Obesity, as well as several preclinical programs utilizing the company's broad RNA therapeutics toolkit. Driven by the calling to 'Reimagine Possible', Wave is leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Wave is headquartered in Cambridge, MA. For more information on Wave's science, pipeline and people, please visit and follow Wave on X (formerly Twitter) and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding our expectations for WVE-007 and the anticipated therapeutic benefits thereof; the anticipated timing of clinical data from our INLIGHT clinical trial of WVE-007; the novelty of our approach to silence INHBE mRNA in order to achieve healthy, sustainable weight loss and the potential for once- or twice-yearly dosing; the potential benefits of WVE-007 over existing obesity therapies; the potential of WVE-007's mechanism (INHBE) as a novel and unique obesity treatment to induce fat loss, preserve muscle, and drive weight loss; our understanding of our preclinical data for WVE-007 and our expectations of how such data will translate in humans; beliefs that Wave's portfolio of RNA medicines is differentiated, potentially best-in-class and potentially transformative; the broad potential of Wave's RNA medicines pipeline and oligonucleotide chemistry and any benefits that may arise as a result thereof. The words 'may,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'target' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release and actual results may differ materially from those indicated by these forward-looking statements as a result of these risks, uncertainties and important factors, including, without limitation, the risks and uncertainties described in the section entitled 'Risk Factors' in Wave's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as amended, and in other filings Wave makes with the SEC from time to time. Wave undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances. Contact:Kate RauschVP, Corporate Affairs and Investor Relations+1 617-949-4827Investors:InvestorRelations@ Media:MediaRelations@ in to access your portfolio
Yahoo
2 hours ago
- Yahoo
Novo Nordisk's subcutaneous and oral amycretin data published in The Lancet and presented at ADA 2025
Subcutaneous amycretin phase 1b/2a data on the safety, tolerability and weight loss potential in people with overweight or obesity was published in The Lancet and presented at the American Diabetes Association (ADA) Scientific Sessions.1,2 Oral amycretin phase 1 data on the safety, tolerability and weight loss potential in people with overweight or obesity was also published in The Lancet.3 Findings from the clinical trials indicate amycretin appeared tolerable with a safety profile consistent with other GLP-1 and amylin receptor agonists.1,2,3 Bagsværd, Denmark, 20 June 2025 – Novo Nordisk announces subcutaneous amycretin data being presented at the American Diabetes Association (ADA) 85th Scientific Sessions in Chicago, US.1 Full results of two clinical trials evaluating the safety, tolerability and weight loss potential of subcutaneous and oral amycretin in people with overweight or obesity were published today in The Lancet medical journal.1,3 Amycretin is the first treatment that combines GLP-1 and amylin receptor agonism biology in a single molecule. The published and presented results from the once-weekly subcutaneous amycretin phase 1b/2a clinical trial showed that participants who received the treatment demonstrated significantly greater weight loss across the full range of doses investigated compared to placebo. Data being presented at ADA were collected from two parts of the trial; dose escalation (amycretin 60 mg), and dose escalation and maintenance (amycretin 20 mg, 5 mg and 1.25 mg).1,2 No plateauing in weight reduction was observed at the end of treatment (ranging from 20 to 36 weeks) with all tested doses, suggesting that a longer treatment duration may potentially contribute to additional weight loss.1,2 Estimated mean change in body weight from baseline with once-weekly subcutaneous (SC) amycretin: 1,2 * Dose Treatment % Weight change % Weight change duration (SC amycretin) (placebo) 60 mg 36 weeks -24.3% -1.1%20 mg** 36 weeks -22.0% 1.9%5 mg** 28 weeks -16.2% 2.3%1.25 mg** 20 weeks -9.7% 2.0% * If all people adhered to treatment i.e. if all people followed the planned dosing schedule for the full trial period without any treatment discontinuations.** Administered during a 12-week maintenance period. Once-weekly subcutaneous amycretin treatment escalated up to 60 mg appeared tolerable with a safety profile consistent with other GLP-1 and amylin receptor agonists.1,2 The number of treatment-emergent adverse events (TEAEs) increased in a dose-dependent manner, were mostly gastrointestinal, and were comparable to the rate and profile of TEAEs reported in early-phase studies of GLP-1 receptor, GLP-1 receptor/gastric inhibitory polypeptide (GIP) receptor, and amylin receptor agonists.1,2 The majority of TEAEs were mild to moderate in severity and resolved by the end of the study period.1,2 Of the participants who discontinued the trial, the majority were due to non-TEAE reasons.1,2 'As pioneers in obesity innovation, we are exploring multiple biological pathways to develop potentially transformative medicines that support the individual needs and preferences of people with obesity on their weight loss journey towards overall improved health,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'Amycretin is the first investigational treatment that combines GLP-1 and amylin receptor agonism biology in one molecule, working on distinct pathways and offering complementary effects on appetite control. The findings published and presented today are encouraging. We are excited to advance the clinical development of subcutaneous and oral amycretin into phase 3 to assess its potential as a therapeutic option for weight management.' The published once-daily oral amycretin phase 1 clinical trial data showed that participants receiving amycretin achieved greater weight loss compared to placebo.3 After 12 weeks of treatment with amycretin up to 50 mg and up to 2 times 50 mg, participants achieved a mean change in body weight of -10.4% and -13.1% respectively, compared to -1.2% with placebo.3 There were no apparent signs of weight loss plateauing within the 12 weeks of treatment in either of these amycretin-treated groups.3 Once-daily oral amycretin appeared to have an acceptable safety profile and was tolerable in all tested doses, with TEAEs in line with what was expected from targeting GLP-1 and amylin receptors.3 All reported TEAEs occurred in a dose-proportional manner, were mild to moderate in severity, and mostly gastrointestinal. No new safety signals appeared during the study.3 Based on the findings from the oral and subcutaneous amycretin trials, Novo Nordisk recently announced it will advance amycretin into phase 3 trials to further investigate the treatment as a potential new therapeutic option for weight management.4 About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and for adults with type 2 diabetes. Amycretin is developed for subcutaneous and oral administration. Oral amycretin Phase 1 trial - The trial evaluated the single-ascending dose and multiple ascending doses for oral amycretin, up to 2 times 50 mg, in 144 people with overweight or obesity, with a total treatment duration of up to 12 weeks. Subcutaneous amycretin Phase 1b/2a trial - The trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in 125 people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks. About Novo NordiskNovo 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 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung+45 3077 6414mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________References The Lancet: Dahl K, Toubro, S, Dey S, et al. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: Results of a randomised, controlled, phase 1b/2a study. Dahl, K, et al. (2025). Amycretin, a Novel, Unimolecular GLP-1 and Amylin Receptor Agonist: Results of a Phase 1b/2a Clinical Trial. Poster 2002-LB. American Diabetes Association (ADA) 85th Scientific Sessions, Chicago, US, June 20 – 23, 2025. The Lancet: Gasiorek A, Heydorn A, Gabery S, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, randomised, placebo-controlled study. Novo Nordisk Company Announcement. Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development. Available at: Attachment PR250621-ADA-AmycretinError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Bloomberg
2 hours ago
- Bloomberg
Novo's Latest Obesity Drug Shows 24% Weight Loss in Small Trial
Novo Nordisk A/S's latest experimental obesity drug helped patients lose as much as 24.3% of their weight in a small study, showing its potential as a next-generation treatment in the hyper-competitive market. The drug known as amycretin showed signs of improving blood sugar levels with side effects generally in line with other powerful obesity medicines, researchers said in a pair of trials published in The Lancet and due to be presented at the American Diabetes Association conference in Chicago. The 24.3% weight loss came over 36 weeks in a study of the shot version of the compound.
