Health & Wellbeing

FDA approves "game-changing" new weight loss drug

FDA approves "game-changing" n...
Recently completed Phase 3 trials showed Wegovy to be more effective than any other currently available weight-loss medication
Recently completed Phase 3 trials showed Wegovy to be more effective than any other currently available weight-loss medication
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The treatment involves weekly sub-cutaneous injections
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The treatment involves weekly sub-cutaneous injections
Recently completed Phase 3 trials showed Wegovy to be more effective than any other currently available weight-loss medication
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Recently completed Phase 3 trials showed Wegovy to be more effective than any other currently available weight-loss medication

The US Food and Drug Administration (FDA) has approved a new weight management drug called Wegovy (semaglutide). The drug was first approved as a type 2 diabetes treatment in 2017 and has subsequently been described as a “game-changer” for obese or overweight adults.

Semaglutide is a relatively new drug, originally developed to increase insulin secretion as a treatment for type 2 diabetics. It was approved by the FDA as a treatment for diabetes in late 2017.

The drug works by mimicking the actions of a naturally-occurring hormone called GLP-1. As well as influencing blood sugar levels, GLP-1 has been found to play a role in suppressing appetite. The hormone is produced by intestinal cells helping tell the brain when we have eaten enough food.

Several large recently completed Phase 3 trials testing the drug as a weight-loss treatment saw average reductions of 15.3 kg (33.7 lb) after 68 weeks. This made the drug more effective than any other currently available weight-loss medication.

The dose of semaglutide used in Wegovy is around double what is used to treat type 2 diabetes. The drug is administered via a once-weekly sub-cutaneous injection and the FDA notes the treatment is approved for, “chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol).”

It is important to note the trials testing semaglutide for weight loss included significant behavioral changes in their protocols. Alongside the weekly injection all subjects were directed to follow a calorie-controlled diet and engage in at least 150 minutes of physical activity each week.

The treatment involves weekly sub-cutaneous injections
The treatment involves weekly sub-cutaneous injections

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” says John Sharretts, from the FDA’s Center for Drug Evaluation and Research. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”

Novo Nordisk, the pharmaceutical company behind Wegovy, is yet to reveal the market price of the drug but it has been predicted to cost over US$1,000 per month. The current monthly cost of semaglutide for type 2 diabetes is over $850.

Source: FDA

6 comments
6 comments
martinwinlow
I was under the impression that one of the causes (if not the main one) of Type 2 diabetes (T2B) was that the pancreas can't produce sufficient insulin to properly regulate blood sugar - due to being 'worn out' coping with multiple daily hits of massively high blood sugar spikes from ingesting 'food' rammed with very simple carbohydrates ie sugar - and hence the onset of T2B.

If Semaglutide 'increase(s) insulin secretion' how will that work with a patient who already can't produce enough insulin?

I've obviously missed something....
Aross
I'm curious as to how effective this really is. It says in the article "Alongside the weekly injection all subjects were directed to follow a calorie-controlled diet and engage in at least 150 minutes of physical activity each week." Would that not in and of itself provide the necessary weight reduction?
paul314
One of the major "side" effects of the drug at diabetic dosages is appetite suppression, apparently partially due to chronic low-level nausea. So I wouldn't be surprised if this were part of the weight loss effect as well. (It may also be part of the effectiveness in controlling type 2 diabetes, which can be helped by weight loss and by reducing consumption of carbs.)

It would be interesting to see the dropout rates for the studies that supported approval.
Jedi Beavis
If you "follow a calorie-controlled diet and engage in at least 150 minutes of physical activity each week," I would expect to be able to drop less than 40 lbs in 16 months. What does the drug do to help? Besides cost $1,000 a month?
Karmudjun
I see the comments are due to googling the GLP-1 class. Yes, Type II diabetics have issues with INSULIN RESISTANCE due to poor diet, low exercise tolerance or initiative, and possible familial hormone deficiencies of older age. So you may think type II is a disease that starts with an inability to produce insulin on demand - no it is a disease of too much insulin released on demand, precipitous blood glucose drop, liver induced glucose release, high blood glucose again prompting more insulin release, resulting in continued insulin resistance and extreme stress on the insulin producing cells - eventually destroying them.

The population that has trouble loosing weight have that trouble in spite of modifying their diet and exercise habits to compensate. The intricate hormone feed back mechanisms work to the obese patient's disadvantage. If you never enter the metabolic syndrome population, you really can't understand how the issues compound - but go ahead and comment. Medical doctors and some nutritionists are well aware of what you aren't.

Having tried many non-addicting medications prior to prescribing them to my patients, the nausea induced by GLP-1 medications is not a reason to avoid eating - and avoiding eating doesn't work for weight loss either, the body compensates by pulling from protein "stores" (ie., muscles) and fat stores. And since the only major side effect of this class in the prescription population prior to FDA indication expansion - is hypoglycemia. The concern SHOULD be for normal (non-diabetic as well as sub-clinical undiagnosed type II diabetics) who may experience hypoglycemia with the "double dose" of the GLP-1 administered in depot once a week.

Do not use drugs just because - this is no "game changer" for the obese. It is yet another tool after all the others have proven marginal at best.
And Martinwinlos - you aren't wrong in toto, but you have the mechanism of developing type II diabetes backwards, the metabolic syndrome or insulin resistance is the pathway toward the eventual pancreatic failure of beta cell insulin production. A common misconception - and I'm glad to clarify the process. Type II leads into Type I due to the strain on the Pancreas.
clay
What a joke. All the billions of dollars, decades of "advancement" and yet pharmaceuticals and mainstream science still uses the fundamentally flawed playbook of Reduced Calories and MORE insulin?

FAST and eat meat.. the fattier the better. Liver and kidneys are the best.

Personal anecdotes are not "proof" and yet they are worthy of reviewing: I dropped 50 pounds (~23kg) in just under 2.5 months.. not by calorie restriction, low fat, drugs...etc. I did it by FASTing. Just water (with electrolytes) for 7-9 days.. then eating high fat meats for a week.. then fasting again for a week. One week on, one week off...

It would have seemed crazy to think i could even attempt such a thing.. but the human body was *BUILT* for this kind of cycle.
Think about it.

The result:
My blood pressure dropped, blood sugar levels dropped, focus (and I mean FOCUS) improved, brain fog gone.. all around: amazing.

No drugs required, no WaitWatchers required. Just avoid bread and beer (most the time) and avoid added sugar (allolose and others are pretty good alternatives these days)...and eat LOTS of meat with the fat on.

Check with your doc (duh) first. But I recommend finding a doc that is friendly to fasting and keto/carno (e.g. Doc Ken Berry, on youtube, if you are in tennessee).