STAT reports on Eli Lilly drug trial of tirzetapide as a treatment for the liver disease MASH, with ‘…74% of adults in the trial taking the drug were free of MASH after 52 weeks.’
This impact beyond weight loss per se, is important to further define the role of anti-obesity medications to treat clinically significant disease, from fatty liver disease to diabetes to hypertension.
There is a hope ‘…that insurers will be swayed by evidence these medications provide other health benefits…’ moving away from weight loss as a cosmetic treatment.
CNBC reports on Eli Lilly sales of Zepbound, which won approval from U.S. regulators in early November, at $175.8 million for the fourth quarter of 2023.
Eli Lilly is the largest pharmaceutical company based in the U.S. with a market cap of roughly $673 billion, and total fourth quarter revenue of $9.35 billion.
The forecasted 2024 revenue was stated to be between $40.4 billion to $41.6 billion, supported by increasing demand for tirzetapide.
In addition, Mounjaro booked $2.21 billion in sales for the fourth quarter, up from just $279.2 million in the same period a year ago.
The only way is up…
OPINION
Business Insider reporter Shelby Livingston notes ‘…startup Ro just started prescribing “compounded” semaglutide, an alternative to Ozempic.’
Ro ‘…started prescribing the compounded drug about two months ago to ensure that its patients can stay on medication when brand-name drugs are hard to find…’ as a backup, spurred on by supply shortages.
Whilst there are multiple webistes, medspas and telehealth clinics prescribing compounded weight loss drugs, Ro has taken a stance to ‘…effectively endorse compounded semaglutide by prescribing it.’
Compounded drugs may be of poor quality and just not work, or potentially harmful if contaminated with other ingredients; the drugs are not tested or approved by the US Food and Drug Administration.
There have been 165 reports to the FDA of adverse events related to compounded semaglutide from August 2021 through January 23, 2024; this is very small number, even though it is unknown how many Americans are taking the compounded drug.
Novo Nordisk and Eli Lilly have taken legal action against compounding pharmacies, and medspas that are prescribing such drugs too.
In counter, ‘…Weight Watchers, Noom, and Found, are steering clear of compounded GLP-1s.’
Ro says ‘…patients can trust that it’s done the legwork to ensure its compounded semaglutide is safe and works…’ with ‘…extensive quality checks by third-party labs that Ro hired.’
Dani Blum at The New York Times looks ‘…for ways to counteract the muscle loss that can happen…’ on weight loss drugs.
Gyms offering strength-training programs, nutritionists focused upon protein-rich meal plans, and pharmaceutical companies are exploring drugs to regulate muscle mass.
Noom now has ‘…a Muscle Defense program that includes fitness videos and a protein tracker.’
Milliman, an international actuarial and consulting firm based in Seattle, Washington, explores the concept of an obesity center of excellence.
Austin Barrington and colleagues outline a white paper, commissioned by Eli Lilly, to develop a ‘…targeted obesity care model combined with a risk-sharing financial component may align provider and employer incentives for treatment of obesity.’
Employee wellness programs, obesity telehealth programs, and traditional clinical services inclusive of anti-obesity medications and bariatric surgery are considered.
The financial implications of obesity to an employer are significant, with ‘…each one-unit BMI increase is associated with an additional cost of $253 per person per year…’ and additional impact on absenteeism and presenteeism.
Centers of excellence have ‘…been implemented to improve value in multiple conditions and medical episodes from cancer to knee replacement…’ to provide best-in- class care through a specific provider network.
A center of excellence provides comprehensive and effective obesity care, with a personalized treatment plan, comprising lifestyle support, medication, and surgical therapies.
Scope of services, patient eligibility, the provider network, and a technology platform are essential components, supplanted by financial structures and contracting.
I welcome and support the Milliman approach, to be fully aligned with twenty30 health, to deliver whole-person, longitudinal, multimodal care for over one hundred million Americans managing with obesity and related diseases.
Thank you.
No-zempic is leaving lots of people behind, from Yasmin Tayag at The Atlantic.
Anita from Arizona and Tina from Florida simply did not lose any weight on the drug; they respond weakly or did not respond.
Somewhere between one in six to one in three people are non-responders, due to genetics, metabolism, and other unknown effects.
It may be that one drug works better for them than another – think of it like chemotherapy; it does not work the same for everyone, with the same tumor type.
Indeed, patients like Anita and Tina may be great candidates for bariatric surgery – which again though, does not yield the same result for everybody.
Newer and better drugs will help, but the human body is amazing in its diversity; indeed the ‘…disease is simply too complex, with too many drivers, for a single type of medication to treat it.’
DATA
A fascinating publication in Nature Medicine this week, focuses upon AMG 133, known as maridebart cafraglutide, or Maritide, an antibody developed by Amgen that impacts GLP-1 and its lesser known cousin, GIP, or glucose-dependent insulinotropic polypeptide.
The drug has been shown to reduce body weight in laboratory mice and monkeys, as well as impact blood glucose, insulin, and cholesterol levels.
An additional study recruited 49 obese human subjects – some of whom were injected with the drug just once; those on the highest 840mg single dose maintained a total weight loss of 8.2% at up to five months – let me say that again… this was just based on a single shot.
An additional group received three shots of 420mg over two months – they lost almost 15% of total body weight by the third dose, and without any further medications, maintained this to an 11% weight loss at seven months, which was five months since their last dose.
Having a drug that is taken monthly is a competitive edge; the additional durability out to five months since the last injection has game-changing potential – data from Zepbound and Wegovy trials show a weight rebound much sooner after stopping the drug.
Past colleague and friend Prof Carel Le Roux publishes in The Lancet on almost 400 subjects enrolled to receive varying doses of survodutide for 46 weeks; the highest dose led to almost 15% total body weight loss.
Survodutide, developed by Boehringer Ingelheim works on GLP-1 and glucagon hormones, in that it reduces appetite with the novel impact to also increase liver energy expenditure.
A 600 patient study in the journal Hypertension evaluated the role of tirzetapide in 24h blood pressure reduction by about 10 points.
In addition, nighttime systolic BP, which is a stronger predictor for cardiovascular death and all-cause death than daytime and 24-hour systolic BP, was also significantly reduced by tirzepatide.
Once again, we are seeing the role of GLP-1 medications beyond weight loss; exactly how we need to think of treatment for people with obesity and related metabolic disease.
From 100 subjects enrolled, almost half those who had undergone gastric bypass were in remission, or cured, of their high blood pressure.
The total number of medications taken were reduced from 3 per day, to less than 1 per day, whilst maintaining a normal blood pressure.
Indeed, bariatric surgery ‘…represents an effective and durable strategy to control hypertension and related polypharmacy in subjects with obesity…’ with a concomitant reduction in medical expenditures too.