Oral Semaglutide: Diabesity Business As Usual Is Doomed

Wachet auf! As if the clues were not already present, an announcement yesterday makes it plain. Competitors in the sleepy diabesity market had best wake up. The first ever oral GLP-1 agonist for diabetes and obesity – semaglutide – is looking good in clinical trials. That means everyone else had better get serious about innovation. Or risk becoming irrelevant.

Phase 3 Results

The results announced yesterday were from PIONEER 1, a phase 3 study with three different doses of oral semaglutide. As an injection, FDA approved this drug late last year for type-2 diabetes. Studies of the injectable form are ongoing for obesity.

Just showing that this drug can work in an oral form without too much nausea was plenty of good news. But in fact it was comparable to – or maybe a little better than – the rate of nausea typically seen with injections. That was a good surprise. What’s more, at the highest dose tested, researchers saw significant weight loss: 4.7% versus baseline. That’s noteworthy because this was a study of doses for treating type 2 diabetes.

Dosing for obesity will be higher and, presumably, more effective. We’re still waiting for a good look at efficacy in obesity. This study was the second and the largest to date showing that oral semaglutide works for type 2 diabetes. If all goes well, Novo Nordisk will complete additional diabetes studies and file for approval in 2019.

Obesity filings will come later.

Business As Usual: A Slow Motion Disaster

Reading the reaction of stock analysts was mildly entertaining. Will an oral GLP-1 drug put a big dent in Lilly’s prospects for Trulicity? It’s a once-weekly injectable GLP-1 product expected to be a multi-billion dollar blockbuster. Nope, says Bernstein’s Tim Anderson:

Given the high-growth nature of the GLP-1 category, there will be enough room for both companies’ products to grow.

That kind of complacency led GSK and Sanofi to become irrelevant in the diabetes market. GSK pushed Avandia for years, despite the fact that it caused weight gain. When problems with long-term outcomes cropped up, the company eventually had to throw in the towel.

Sanofi also has dim prospects in the diabetes market. For years, that company counted on little tweaks to insulin products for growth. Sanofi also failed to develop viable obesity drugs and gave up.

But here’s the news flash. More of the same old injectables for diabetes will not be good enough. Ignoring obesity will no longer work for anyone. Not for doctors or for patients, and certainly not for biomedical innovators. Diabetes and obesity are enormous threats to health and they are inseparable.

If Lilly doesn’t get serious about innovating for obesity, its diabetes portfolio will also fade. Diabesity business as usual is a recipe for failure.

Click here for more from FiercePharma and here for more from Reuters. For an earlier phase 2 study of oral semaglutide published in JAMA, click here.

Complacent, photograph © Madilyn Peiper / flickr

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February 23, 2018

2 Responses to “Oral Semaglutide: Diabesity Business As Usual Is Doomed”

  1. February 23, 2018 at 8:01 pm, Brian Scott Edwards MD said:

    The treatment for Chronic obesity is multiple diet medications.
    Seven simple steps.
    Metformin should be started for pre-diabetics with fasting glucose greater than 99..
    Liraglutide (Victoza) injection should be second drug for obese diabetic type 2. The new oral semaglutide will be good for those who don’t want to take injections if it works and is tolerable)
    Canagliflozin (Invokana) should then be added for further glucose control for type 2 Diabetes.
    Great news is these medications are covered by insurance.
    Hopefully during this period the patient has been on LCHF (low carbohydrate high fat) or some form of Atkins diet or South Beach Diet.
    Check that carbohydrates are low enough to cause nutritional ketosis with urine strips or blood sticks.
    To lose more weight and then maintain weight loss a patient will eventually need to be on either Qysemia, Contrave or Belviq for the rest of their lives.
    Good news is people only need to walk 20 to 30 minutes a day or achieve 5,000 to 10,000 steps a day. Exercise is for health not weight loss.
    Drink decaf coffee in morning so that afternoon hunger can be treated with a strong cup of regular coffee.

    Insulin and Bariatric surgery should be reserved for those who fail the above and have morbid obesity.

  2. February 24, 2018 at 3:18 am, Ted said:

    Interesting ideas here, thanks for sharing them.

    I’ve yet to see a singular protocol that works for everyone with obesity. I’m also not a big fan of the term “morbid obesity.” See this publication for more perspective: