Posted on 05/09/2022 10:40:21 AM PDT by Red Badger
An experimental drug being clinically investigated for its effects on body weight in obese and overweight people has delivered record-breaking weight loss for participants in the trial – on par with surgical options, the company behind the drug suggests.
Tirzepatide, developed by American pharmaceutical company Eli Lilly and Company (Lilly), is a once-weekly injection that promotes weight loss by mimicking the effects of natural hormones called incretins. These hormones lower blood sugar after we eat, in addition to regulating metabolic processes related to digestion.
In the case of tirzepatide, which is not yet available on the market pending further clinical study, the drug is a synthetic combination of two particular incretins, called GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide).
The former hormone, GLP-1, is the basis of the anti-diabetes medication semaglutide, which was approved in the US as a weight-loss drug in 2021, representing the first time the FDA had endorsed a new treatment for weight loss in several years.
That approval was granted on the back of results described as a 'game-changer' for weight loss, but it looks like tirzepatide's formulation – thanks to the addition of GIP alongside GLP-1 – might well change the game again.
In Phase 3 results from the ongoing SURMOUNT–1 clinical trial investigating the effects of tirzepatide, researchers enrolled 2,539 participants who were either overweight or obese (with one weight-related comorbidity but without type 2 diabetes).
The participants received tirzepatide or a placebo over the course of 72 weeks, along with support to follow a reduced-calorie diet and increase their levels of physical activity.
Tirzepatide was administered at one of three different doses (either 5, 10, or 15 milligrams in the weekly injection), but all three groups saw significant levels of weight loss over the course of the study.
On the highest dose (15 mg), participants saw average weight reductions of 22.5 percent of their body weight (24 kg or 52 lb), while the 10 mg dose achieved 21.4 percent weight loss (22 kg or 49 lb), and 5 mg saw a 16 percent body weight reduction (16 kg or 35 lb).
By comparison, the placebo group lost only 2.4 percent of their body weight (2 kg or 5 lb). Previously, the semaglutide weight loss trials averaged a roughly 17 percent weight loss.
"Tirzepatide is the first investigational medicine to deliver more than 20 percent weight loss on average in a phase 3 study," says clinical research physician Jeff Emmick, the vice president of product development at Lilly.
While the results have not yet been peer-reviewed, Lilly says they will be submitted for such consideration in the future. Meanwhile, study in the SURMOUNT-1 trial is ongoing, alongside related SURMOUNT trials, the results of which are expected to be announced in 2023.
However, we do already know that tirzepatide does not agree with everyone who takes it. While the averaged weight-loss results do appear to slightly outperform treatment with semaglutide, and are about on par with the weight loss patients might expect from bariatric surgery, some participants in the tirzepatide arm experienced adverse effects.
Depending on dose, up to one-third of the group on tirzepatide experienced nausea, while diarrhea was also relatively common (for 18.7–23 percent of participants). Some people also experienced vomiting and constipation, although it's worth noting only a small percentage of participants left the study due to these effects.
Yet another potential barrier to stomaching tirzepatide is the issue of price – assuming subsequent research results convince the FDA to approve the drug for weight-loss patients, that is. (The drug has already been submitted for regulatory review for diabetes treatment.)
As others have noted, semaglutide – sold as a weight-loss drug under the brand-name Wegovy by Danish pharmaceutical company Novo Nordisk – sells for over US$1,300 per month, and very few patients can afford such an expensive medication, especially when drugs like this are rarely covered by health insurance.
If tirzepatide follows a similar pricing strategy – upon its expected but not-yet-assured future release – this could be another case of a potentially brilliant, life-changing medication that many people sadly won't be able to buy.
"The drugs themselves appear to be great, but Wegovy is expensive, and the others probably will be too," neuroscience and obesity researcher Stephan Guyenet told Gizmodo.
"This is especially true in the US, where Wegovy costs about four times more than in other countries. So the main question becomes one of access."
Aside from the economics, the impressive results of these medications nonetheless suggest we might soon be able to transform the treatment of obesity – a complex and harmful epidemic that has resisted our control for decades.
If we can realize that promise, and ensure equitable access to this new generation of obesity medications, we stand to improve the health of millions of people around the world, researchers say.
"This is extremely exciting, albeit preliminary data showing bariatric surgery-level weight loss from a medication, one that likely affords numerous other metabolic benefits," Scott Kahan, the director of the National Center for Weight and Wellness in Washington, DC, told Healio.
"Continued development of tirzepatide and similar agents could portend a sea change in obesity treatment, similar to how cholesterol and heart disease management was transformed by the advent of statin medications and how HIV management was transformed by antiretroviral medications."
Whether the reason for obesity is medical or not, once you’re there, you’re there. And at risk for all the (very expensive) maladies that come with it.
It is foolhardy for insurance companies not to cover the great bulk of the cost for those who comply with the diet and exercise regimen. The saved costs from preventing great amounts of obesity related illness would repay the cost of the drug many times over.
Where do I get me some?.......................
Don’t forget the other benefits of your advice. Less money spent on food, eating healthier foods, less fat, (obesity has been associated with cardiac disease, certain cancers, less trips to the wrapper, can wear your older clothes(when we were skinnier)....less medicines....win all around..
The COVID jabs are effective too. You lose a lot of weight when you die.
Have you tried any fasting? I’ve lost 220lbs over the last 5 years by following a low carb diet and fasting 48-120 per week (2-5 days). Yes, I was wearing circus tents, now I’m a curvy XL. I do extended fasts due to my extreme weight and apparently useless metabolism. The results have been pretty astounding, I don’t even have loose skin because the autophagy of long fasts tightens it all up.
My husband lost 50lbs just with the low carb, he hasn’t ever really fasted more than 24 hours. He could stand to lose another 10-15. He’d probably shake them off like dust just doing a single 36 hour fast per week.
I appreciate that losing weight is difficult, but if you are that heavy…not losing weight on 1,000 calories a day…I have to call you on that.
Unless your new doc is an endocrinologist, and they are waiting a paper on you…your numbers don’t work. From a pure physics point of view, moving that much weight throughout a day takes at least 2,400 calories to just maintain. No one’s body is as efficient as you write.
The live tapeworm eggs will do it for sure!!
;-)
Wish I could say I did it on purpose. ;-)
“Anyone who follows a reduced calorie diet and increase their physical activity will loose weight.”
Wish it was that easy. The drug is used to cut the amount of sugar in the blood. But what do you do with hypoglycemia which already displays low sugar counts, and requires much larger food intakes than Hyper? Insulin resistance comes into focus and there are many times other things that impact exercise and how much can be accomplished. It is more than just pushing yourself away from the table and running a lap.
Also, it has been proven that diabetes is tied into heredity. It can be effected by stress, sleep, and diet, even low carb diets like Atkins or Keto aren’t by themselves the answer to the illness and the other effects from it. People don’t die from diabetes. They are killed by the effects of it like heart attack and stroke.
I read the MSDS for this, and it appears to be like ozempic, a semaglutide injection, a once-weekly noninsulin medicine that along with diet and exercise, may help improve blood sugar in adults with type 2. But it also occasionally passes out the same side effects that may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation. And weight loss is not guaranteed in all patients. Like mentioned above, it is not recommended for all patients either. Wish it was good for all. And diabetes is not a science. It is a daily effort to control a number of problems and side effects so the expectations of most patients can be very different. And very hard to reach in that most.
wy69
Take a look at people on the ‘Carnivore’ diet. Side effects are beneficial as well as the weight loss, ease of following the simple rules, control of appetite, improvement in teeth, gums, skin health, digestive tract happiness, sleep better... Take the 30 day challenge!
Got it documented. Back when I was 30 I had to go down to 900 calories a day to lose 25 pounds in 6 months. Was on a plan that provided the food - Nutra System - and ate nothing out of the plan. My wife works with me - we are literally a mom and pop shop - and she sees EVERYTHING I eat. I have kept food diaries, weighed and measured everything I ate, I log my exercise. It seems that my burn-calories-by-existing count is in the 500 to 600 calories a day instead of the around 2000 it should be. My body temp is 95 to 96 degrees, all the time. My insurance will not pay for an endocrinologist for "weight loss".
As an aside, I have wicked bad sleep apnea. My CPAP gets me down to 5 to 10 instances per hour, but without it I am over 90 instances per hour. My respiration drops to about 10 to 12 per hour while sleeping, a little low. My apena is a combination of obstructive and central (neurological). When I was on the amphetamine my apena (with CPAP) dropped to about 3 instances per hour. No one can explain it.
For Healthcare Professionals
Applies to teriparatide: subcutaneous solution
General
The more commonly reported side effects have included arthralgia, pain, and nausea.
Hypersensitivity
Rare (less than 0.1%): Anaphylaxis, possible allergic events soon after injection (e.g., acute dyspnea, oro/facial edema, generalized urticaria, chest pain, edema (mainly peripheral)
Postmarketing reports: Drug hypersensitivity, angioedema, urticaria[Ref]
Oncologic
Frequency not reported: Osteosarcoma[Ref]
Cases of bone tumor and osteosarcoma have been reported during the postmarketing period; however, an increased risk of osteosarcoma was not observed in observational studies. Two osteosarcoma surveillance safety studies (US claims-based database studies) designed to assess the incidence rate of osteosarcoma showed 3 osteosarcoma cases among 379,283 patients and zero cases among 153,316 patients receiving this drug. A similar risk for osteosarcoma has been observed with comparators. The interpretation of these results suggests caution as data sources do not allow for complete measurement and control for confounders.[Ref]
Genitourinary
Frequency not reported: Urolithiasis
Cardiovascular
Common (1% to 10%): Hypotension, hypertension, palpitations, chest pain, angina pectoris
Uncommon (0.1% to 1%): Tachycardia, cardiac murmur
Frequency not reported: Peripheral edema[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, vomiting, hiatus hernia, gastro-esophageal reflux disease, constipation, diarrhea, dyspepsia, gastrointestinal disorder, tooth disorder
Uncommon (0.1% to 1%): Hemorrhoids[Ref]
Musculoskeletal
Very common (10% or more): Pain in limb, arthralgia (10%)
Common (1% to 10%): Muscle cramps, neck pain, leg cramps
Uncommon (0.1% to 1%): Myalgia, arthralgia, back cramp/pain
Postmarketing reports: Muscle spasms of the leg or back[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache, sciatica, syncope[Ref]
Respiratory
Common (1% to 10%): Dyspnea, rhinitis, cough increased, pharyngitis, pneumonia
Uncommon (0.1% to 1%): Emphysema[Ref]
Dermatologic
Common (1% to 10%): Rash, sweating increased[Ref]
Endocrine
Frequency not reported: Transient hypoparathyroidism[Ref]
Hematologic
Common (1% to 10%): Anemia[Ref]
Local
Common (1% to 10%): Mild and transient injection site events (e.g., pain, swelling, erythema, localized bruising, pruritus, minor bleeding at injection site)
Uncommon (0.1% to 1%): Injection site erythema, injection site reaction[Ref]
Metabolic
Common (1% to 10%): Hypercholesterolemia
Uncommon (0.1% to 1%): Hypercalcemia (greater than 2.76 mmol/L), hyperuricemia, weight gain, alkaline phosphatase increase
Postmarketing reports: Calciphylaxis, worsening of previously stable cutaneous calcification[Ref]
Other
Very common (10% or more): Pain (21%)
Common (1% to 10%): Vertigo, fatigue, asthenia, syncope[Ref]
Psychiatric
Common (1% to 10%): Depression, insomnia[Ref]
Renal
Uncommon (0.1% to 1%): Urinary incontinence, polyuria, micturition urgency, nephrolithiasis
Rare (less than 0.1%): Renal failure/impairment[Ref]
For the Consumer
Applies to teriparatide: subcutaneous solution
Side effects requiring immediate medical attention
Along with its needed effects, teriparatide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking teriparatide:
More common
Confusion
constipation
depression
dry mouth
headache
incoherent speech
increased urination
loss of appetite
metallic taste
muscle weakness
nausea
stomach pain
thirst
unusual tiredness
vomiting
weight loss
Less common
Arm, back, or jaw pain
chest pain, discomfort, tightness, or heaviness
cough
fainting
fast or irregular heartbeat
fever or chills
nausea
sneezing
sore throat
sweating
trouble breathing
Incidence not known
Hives or welts, itching, skin rash
redness of the skin
swelling or puffiness of the mouth and face
Side effects not requiring immediate medical attention
Some side effects of teriparatide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Acid or sour stomach
belching
blurred vision
body aches or pain
diarrhea
difficulty having a bowel movement (stool)
difficulty with moving
dizziness
heartburn
hoarseness
indigestion
lack or loss of strength
muscle pain, stiffness, or spasm
nervousness
pain in the joints
pounding in the ears
runny or stuffy nose
tender, swollen glands in the neck
trouble with swallowing
voice changes
Less common
Back pain
discomfort
discouragement
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
feeling of constant movement of self or surroundings
feeling sad or empty
indigestion
irritability
lack of appetite
leg cramps
loss of interest or pleasure
neck pain
sensation of spinning
sleeplessness
stomach cramps
swollen mouth and tongue
tiredness
tooth disorder
trouble concentrating
trouble sleeping
unpleasant taste
urge to have bowel movement
Incidence not known
Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
flushing
unusually warm skin
https://www.drugs.com/sfx/teriparatide-side-effects.html
Typical long, long list of potential side effects of a drug. Somehow the public was never shown such a list for Covid “vaccines”. Instead scenes with butterflies and fields of daisies advised people to help others by getting the jab.
“metabolic issues”
That would be funny if it wasn’t so serious. Fact: Most ‘metabolic issues’ are an effect of lifestyle disease.
One such ‘disease’ was acid reflux.
Those proton pump inhibitors which used to be RX ONLY are now OTC and reeking havoc upon those self-diagnosing themselves.
If this drug remains RX only, I’d be satisfied.
But I seriously doubt that will be the case.
Don’t forget the dexedrine.
Then there was Jimmy Buffet’s temporary diet, losing weight without speed eating sunflower seeds, drinking lots of carrot juice and soaking up rays.
“Depending on dose, up to one-third of the group on tirzepatide experienced nausea, while diarrhea was also relatively common (for 18.7–23 percent of participants). Some people also experienced vomiting and constipation, although it’s worth noting only a small percentage of participants left the study due to these effects.”
So, the “success” of this drug at helping people lose weight is proportional to the amount of digestive distress it causes.
Would it be surprising to discover that people with digestive distress also ate less as a result?
Unimpressed.
Cases of bone tumor and osteosarcoma have been reported during the postmarketing period;...The interpretation of these results suggests caution as data sources do not allow for complete measurement and control for confoundersI'm sure the proclamation will be "Safe & effective".
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.