The ‘King Kong’ of weight loss drugs could be approved in the US within months, its manufacturer says.
In a recent trial, patients who received a weekly 15milligram (mg) shot of Mounjaro lost 15.7 percent of their body weight over 72 weeks on average. For comparison, those in the placebo group lost just 3.3 percent of their weight over the same period.
Eli Lilly, which manufactures the drug, said the results paved the way for it to be approved to treat weight loss. Tirzepatide, the active drug behind Mounjaro, was approved for patients with type 2 diabetes last year.
The drug functions as both a GLP-1 and GIP drug which both triggers hormones that the body to stop eating and increase the body’s secretion of insulin.
It is following in the footsteps of its rivals Ozempic and Wegovy, which were also developed as a type 2 diabetes drug before earning approval for weight loss.
Eli Lilly, which manufactures tirzepatide sold under the brand name Mounjaro, said the results paved the way for the drug to be approved for weight loss. It is already approved to treat type 2 diabetes (Image of Mounjaro at a pharmacy in Provo, Utah)
A total of 938 patients were recruited from eight countries — including the US, Japan and Russia — for the trial, dubbed SURMOUNT-2.
Each participant was both obese and suffering from type 2 diabetes. In the trial, they were split into three equal groups to receive either a weekly 15mg or 10mg of Mounjaro or a placebo.
In the larger dosage group, participants on Mounjaro lost 34.4pounds (lbs) on average. This is compared to just 7lbs in the placebo group.
Participants in the 10mg group lost 13.4 percent of their body weight on average, equivalent to about 29.8lbs (13.5kg) each.
The study also found that about 86 percent of patients who received 15mg and 82 percent of those who received 10mg of Mounjaro lost at least five percent of their body weight.
In the placebo group only 30 percent of patients reached this benchmark.
Jeff Emmick, the senior vice president for product development at Lilly, said: ‘Obesity is a difficult-to-manage disease and it’s even more difficult for people living with type 2 diabetes.
‘The degree of mean weight reduction seen in SURMOUNT-2 has not been previously achieved in phase three clinical trials for obesity or overweight and type 2 diabetes.’
He suggested that the results should lead to the Food and Drug Administration (FDA) approving the drug for weight loss.
It was not clear how much the drugs would cost for weight loss treatment.
They are currently priced at around $1,180 a month — or nearly $300 a shot — for type 2 diabetes treatment.
Mounjaro received the green light for type 2 diabetes patients in May last year, but many doctors have also started prescribing it off-label for weight loss.
Celebrities that have used the drug include comedian Rosie O’Donnell, 60, who alleged she lost 10lbs (4.5kg) in three weeks while on the drug.
Speaking about the drug in a TikTok video, she said: ‘I’d say it feels like freedom. Freedom from intrusive thoughts about food, about what you’re eating.
‘I think it’s fantastic.’
Side effects of taking the drug reported during the trial included nausea, diarrhea, vomiting and constipation.
Rosie O’Donnell is pictured above. She has used Mounjaro to help her lose weight
Mounjaro works by triggering feelings of fullness in patients even when they haven’t eaten — to help them cut calorie consumption and lose weight.
Like semaglutide — sold under brand names Ozempic and Wegovy — it targets the receptors for hormone GLP-1 to trigger feelings of fullness.
But it also targets receptors for the hormone GIP which has a similar effect.
This double-whammy effect has earned it the nickname of ‘King Kong’ among weight loss drugs.
Dr Julio Rosenstock, a veteran diabetes doctor in Texas, told the Wall Street Journal earlier this month that Ozempic and Wegovy were the ‘gorillas’ of weight loss.
He added, however: ‘But tirzepatide is really a King Kong.’]
The FDA approved Wegovy as a weight loss treatment in June, 2021.
This was based on phase three trial results that found patients lost an average of 12.4 percent of their body weight after taking the weekly injections for 68 weeks.
Patients on the drug were about 46 years old and classified as extremely obese.
In a second arm of the study involving patients with type 2 diabetes who were also extremely obese, participants lost about 6.2 percent of their body weight in 68 weeks.
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Read more at DailyMail.co.uk