# Tirzepatide delivers 20%+ weight loss in late-stage trial.



## Eddy Edson (Apr 29, 2022)

Up-coming new T2D & obesity med tirzepatide continues to show brilliant data in trials.


__ https://twitter.com/i/web/status/1519645448620945410
Kind of next-generation med after Ozempic/Wegovy.  Similar side effects: gastro, nausea quite common.  I guess reducing those has to be a goal for other new drugs.


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## travellor (Apr 29, 2022)

Sounds excellent news.


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## Eddy Edson (Apr 29, 2022)

Useful review of the new weight-loss drug lansdscape: https://www.metaculus.com/notebooks...-of-the-next-generation-of-weight-loss-drugs/

And a story today on the developing Novo Nordisk (Wegovy/Ozempic) vs Eli Lilly (Tirzepatide) fight, including their new drug pipelines and the side-effects issue, below. The competition has to be good for reducing the very high prices for these drugs currently.









						Novo fights back
					

A day after Lilly’s strong clinical showing in obesity, Novo comes out swinging.




					www.evaluate.com
				




_The strength of Novo’s sales in obesity and diabetes, led by Wegovy and Ozempic respectively, allowed it to substantially raise its guidance for 2022. Its sales outlook was lifted from 6-10% to 10-14%, and operating profit growth upped from 4-8% to 9-13%. 

Novo’s management is correct in that it would be premature to write the Danish group off, as impressive as yesterday’s data on Lilly’s tirzepatide were. Firstly Novo has a sizeable head start: Wegovy was approved in the US last summer. Doctors were already familiar with the drug in its guise as the diabetes therapy Ozempic, which reached the market in 2017. 

The importance of this market occupancy was underlined by Lilly’s handbrake turn over filing. The group had previously said it would wait for full data from tirzepatide’s Surmount programme in obesity, due in a year or so, before going to regulators. It now hoping to fast-track approval for tirzepatide, with the aim of cutting into Novo’s dominance as soon as possible.

Secondly, the battle will be as much about tolerability as anti-obesity efficacy. Though tirzepatide looks less toxic than Wegovy so far, a lot more data are still due from the Surmount studies. Neither drug is particularly clean, and if patients have to take them chronically to maintain weight loss any advantage on side effects will become hugely important.

....

Competition in the future will also be about the various next-gen compounds the two groups are pursuing. 

Novo is working on cagrisema, a combination of Wegovy with an amylin analogue currently in phase 2 for diabetes and phase 1 for obesity. This is to enter a phase 3 obesity study this year, with Novo looking for weight loss of 25% or more.

Lilly has it own long-acting amylin agonist, which it has just moved into phase 1; the long-term plan here is to combine it with tirzepatide. Yesterday’s data suggest that if it comes down to adding amylin to the obesity therapies, Lilly could have the better backbone for such a combo._


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## Eddy Edson (May 13, 2022)

FDA approves tirzepatide for T2D: https://www.fda.gov/news-events/pre...novel-dual-targeted-treatment-type-2-diabetes

Branded as "Mounjaro".

_Today, the U.S. Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies. 

...

Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones involved in blood sugar control. Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control. Mounjaro is administered by injection under the skin once weekly, with the dose adjusted as tolerated to meet blood sugar goals. 

Three different doses of Mounjaro (5 milligrams, 10 milligrams and 15 milligrams) were evaluated in five clinical trials as either a stand-alone therapy or as an add-on to other diabetes medicines. The efficacy of Mounjaro was compared to placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogs.

On average, patients randomized to receive the maximum recommended dose of Mounjaro (15 milligrams) had lowering of their hemoglobin A1c (HbA1c) level (a measure of blood sugar control) by 1.6% more than placebo when used as stand-alone therapy, and 1.5% more than placebo when used in combination with a long-acting insulin. In trials comparing Mounjaro to other diabetes medications, patients who received the maximum recommended dose of Mounjaro had lowering of their HbA1c by 0.5% more than semaglutide, 0.9% more than insulin degludec and 1.0% more than insulin glargine. 

Obesity was common among study participants, with an average body mass index of 32 to 34 kilograms/height in meters squared reported at the time of enrollment. Among patients randomized to the maximum recommended dose, the average weight loss with Mounjaro was 15 pounds more than placebo when neither were used with insulin and 23 pounds more than placebo when both were used with insulin. The average weight loss with the maximum recommended dose of Mounjaro was 12 pounds more than semaglutide, 29 pounds more than insulin degludec and 27 pounds more than insulin glargine. Those patients receiving insulin without Mounjaro tended to gain weight during the study. 

Mounjaro can cause nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain. 

Mounjaro causes thyroid C-cell tumors in rats. It is unknown whether Mounjaro causes such tumors, including medullary thyroid cancer, in humans. Mounjaro should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2. 

Mounjaro has not been studied in patients with a history of pancreas inflammation (pancreatitis), and it is not indicated for use in patients with type 1 diabetes. _


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## Eddy Edson (May 13, 2022)

Summarising the tirzepatide trial results: 



__ https://twitter.com/i/web/status/1525204435974094852


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