Metsera’s Long-Acting GLP-1; Mount Sinai Partners with Noom; Wegovy and Medicare Price Negotiations; New Guidelines for Bariatric Surgery; WeightWatchers CEO is Out.

AT A GLANCE

  • STAT’s Elaine Chen on Novo Nordisk’s trial of cannabinoid CB1 receptor inhibitor monlunabant, with modest 6.4% weight loss and some psychiatric side effects.
  • Metsera announced phase 1 clinical trial results of MET-097, a long-acting injectable GLP-1 drug with weight reduction of 7.5% at day 36.
  • Modern Healthcare on Mount Sinai partnering with Noom, aimed at behavioral approaches to weight loss.
  • Medicare spent $5.6B on Wegovy in 2022, and almost $7.5B in 2023, and may be ready for Medicare price negotiations in 2027; from the Journal of Managed Care & Specialty Pharmacy.
  • Data published by the CDC revealed between 2021 and 2023, the prevalence of obesity in adults was 40.3%, and severe obesity in adults was 9.4%.
  • From the American Heart Journala 50% uptake of semaglutide over four years would prevent 35,633 MACE and 22,117 all-cause mortality events.
  • The two largest two largest metabolic and bariatric surgery [MBS] organizations in the world, the ASMBS and IFSO, partnered to create new guidelines, published in Obesity Surgery.
  • WeightWatchers parts ways with CEO Sima Sistani, after just over two years at the helm of the lifestyle and food tracking business.

NEWS

  • STAT’s Elaine Chen on Novo Nordisk’s phase 2a trial of monlunabant, a cannabinoid CB1 receptor inhibitor, reporting a modest 6.4% weight loss at 16 weeks, along with a higher rate of some psychiatric side effects like anxiety and sleep disturbances.
    • Higher doses revealed limited additional weight loss.
    • Smaller biotechs on the cannabinoid route, Corbus Pharmaceuticals and Skye Bioscience, saw their stocks sink around 60% and 40%, respectively.
    • For context, rimonabant is earlier obesity treatment that blocked CB1 receptors, and was pulled off the European market in the 2000s due to concerns it was linked to a higher risk of suicidal ideations.
    • Corbus CEO Yuval Cohen, said Novo’s data is not affecting the biotech’s plans to continue developing its own CB1 pill; this comes with lower brain penetration, supposedly making it less likely to lead to suicidality.
  • Metsera, a US-based clinical-stage biopharmaceutical company, announced phase 1 clinical trial results of MET-097, a long-acting injectable GLP-1 receptor agonist.
    • From 125 healthy, non-diabetic, overweight or obese adult participants, there was a change in body weight from baseline to 7.5% at day 36, and on to 8.1% at day 57, four weeks after the final dose.
    • The half-life of 380 hours is based on ‘…the ultra-long clearance conferred by HALO, Metsera’s proprietary, novel peptide lipidation platform technology…’ that translates to a 2-3 fold longer half-life than current meds.
    • Dr. Steve Marso, chief medical officer of Metsera was ‘…excited about these positive results, which position MET-097 as an ultra-long acting, potent, yet well tolerated GLP-1 drug candidate.’
  • Modern Healthcare on Mount Sinai partnering with Noom, aimed at behavioral approaches to weight loss.
    • The companies want to open a two-way referral channel between one another, in hopes of filling gaps in treatment; Mount Sinai may refer select populations to download the Noom Weight app, and in return, the app will direct its customers to Mount Sinai specialists working in weight loss.
    • Lauren Lisher, senior vice president of Mount Sinai Solutions, said patients will be responsible for Noom’s membership fee, ranging from $70 a month to $209 annually, with no direct financial exchange between the two companies under the partnership.
  • WeightWatchers parts ways with CEO Sima Sistani, after just over two years at the helm of the lifestyle and food tracking business.
    • Sistani is to be replaced by interim CEO Tara Comonte, a former Shake Shack executive who joined the WW board in June 2023.
    • WW stock earlier this month hit an all-time low of 67 cents and has lost more than 90% of its value over the last 12 months, to a market capitalization of around $65M.

OPINION

  • Medicare spent $5.6B on Wegovy in 2022, and almost $7.5B in 2023, with expectation for the GLP-1 drug to be included in the next round of Medicare price negotiations, with drug pricing to take effect in 2027; as per authors from a paper published in the Journal of Managed Care & Specialty Pharmacy.
    • Medicare will negotiate the prices of up to 15 Part D products for implementation in 2027.
    • The list of products selected for negotiation will be made publicly available by February 2025.
    • Drugs must be on the market for at least seven years before Medicare can choose them for negotiation, and by February 2025, the first approved semaglutide will have been on the market for seven years and one month.
    • Additional drugs mentioned on the prospect list include anti-cancer therapies, inhalers and antidiabetic products.

DATA

  • Data published by the CDC from the NHANES, or National Health and Nutrition Examination Survey, revealed between 2021 and 2023, the prevalence of obesity in adults was 40.3%, with no significant differences between men and women, or in any age group.
    • The prevalence of obesity was lower in adults with a bachelor’s degree or more, than in adults with less education.
    • The prevalence of severe obesity in adults was 9.4%, and was higher in adults ages 20–39 (9.5%) and 40–59 (12.0%) than in adults age 60 and older (6.6%).
    • Strikingly, the prevalence of severe obesity in men (6.7%) was much lower than in women (12.1%) overall and for each age group.
    • Importantly, obesity is defined by body mass index (BMI), which has limitations; body fat may vary by sex, age, and race and Hispanic origin at a given BMI level.
  • Duke University researchers published in the American Heart Journal on the number of major cardiovascular events [MACE] and deaths from any cause, that could be prevented by nationwide uptake of semaglutide.
    • From almost 4.5 million adults in the US potentially eligible for the medication, a 50% uptake of the drug over four years would prevent 35,633 MACE and 22,117 all-cause mortality events.
    • Just think of the lives impacted when expanded to managing adverse sequalae and deaths in patients with type 2 diabetes, chronic kidney disease, and multiple other chronic conditions.
  • The two largest two largest metabolic and bariatric surgery [MBS] organizations in the world, the ASMBS and IFSO, partnered to create new guidelines, based upon the most up to date high quality published literature along with current expert global practice.
    • From Obesity Surgery, the summary of recommendations comprise MBS in Asian, older and pediatric populations, MBS at BMI of 30 and over 60, MBS prior to joint arthroplasty, abdominal hernia, and organ transplantation, MBS in patients with liver cirrhosis or heart failure, the role of multidisciplinary care, and revisional MBS.
    • Kudos to the authors for a comprehensive and detailed approach, updating indications for MBS that have not changed since the NIH proposed them all the way back in 1991.
  • In JAMA Network Open, from just over 33,000 patients with type 2 diabetes and opioid use disorder, those prescribed semaglutide ranged between a 68% to 42% lower risk of opioid overdose during a 1-year follow-up, compared with other antidiabetic medications.
    • The authors, including Dr. Nora Volkow from the National Institute of Drug Abuse, conclude that semaglutide has potential therapeutic value for preventing overdoses.

DR.RAJESH TWENTLY 30 HEALTH


ADDITIONAL TOPICS

  • An IFSO Consensus Conference: The Role of Obesity Management Medications (OMMs) in the Context of Metabolic/Bariatric Surgery (MBS).
  • Julia Belluz at The New York Times asks Are We Thinking About Obesity All Wrong?
  • U.S. Senate Committee on Why Is Novo Nordisk Charging Americans with Diabetes and Obesity Outrageously High Prices for Ozempic and Wegovy?
  • The Lancet publishes on Jens Juul Holst: physician-scientist and co-discoverer of GLP-1.
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