Eli Lilly to offer early access to 'Godzilla of weight loss drugs' Reta
The manufacturers of Mounjaro are set to give a 'limited number' of patients early access to their experimental obesity drug, Reta, ahead of US FDA approval.
Six weeks after giving a 79-year-old patient early access to its experimental obesity drug, Eli Lilly has confirmed other patients are now also eligible to apply.
A spokesperson said in a statement: "For a limited number of patients who meet specific medical criteria and cannot enrol in a clinical trial, we believe it is medically appropriate to make authentic Retatrutide available before FDA approval, consistent with FDA's guidance."
The 'Godzilla' weight loss drug is yet to be approved by the FDA, and is still being tested in clinical studies.
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However, following an 80-week trial of the drug which concluded in July, Lilly reported that patients with severe obesity and established heart disease lost around 22.6 percent of their body weight while using Retatrutide - which has commonly been shortened to 'Reta'.
The spokesperson added that Lilly has now created an expanded access program, and is actively reviewing requests from healthcare providers.
What are the eligibility requirements?
The company note that eligible patients must be 18 or older, have obesity that hasn't responded to the highest approved dose of weight-loss medication, and have two or more serious or 'life-threatening' obesity-related conditions for which they are currently receiving care.
What is the 'Godzilla' of weight loss drugs?
The new drug works by targeting three different metabolic hormones: GLP-1, GIP and glucagon.
According to The National Library of Medicine, GLP-1s work to help a person feel fuller for longer by slowing down how quickly food leaves the stomach, while GIP works alongside it, encouraging the pancreas to release more insulin when blood sugars rise after eating - helping to reduce hunger and cravings.
Glucagon also helps to regulate blood sugars, while also encouraging the body to break down stored fat and instead use it for energy, which works to support weight loss.
This triple approach is how Reta was coined the 'Godzilla' of the weight loss drugs on the market.
Dr. Cecilia Low Wang, a UCHealth expert on endocrinology, diabetes and metabolism, said: "We've never had a triple-agonist medication. So, this is completely new, and Retatrutide seems to be more potent."
When will Reta be FDA approved?
The pharmaceutical company plans to file for approval for Retatrutide with the FDA in the first quarter of 2027.
What are the side effects?
Those who are currently trialing the drug have taken to a Reddit thread to discuss what side effects they have experienced.
"Fatigue, nausea, insomnia, GERD [gastroesophageal reflux disease], dry mouth," wrote one, which mirrors a lot of other people's experiences when they start a GLP-1 drug.
Another user added: "First few days after my shot I get severe diarrhea, gas and bloating with the occasional nausea."
And a third echoed: "First 2mg dose basically gave me food poisoning symptoms for 2 days. Diarrhea and nausea after eating. Next shot will be 1mg and I’ll see how I feel from there."
In a comment to LADBible Group about the new drug, Eli Lilly previously said: Retatrutide is an investigational, once-weekly, triple hormone receptor agonist, which activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon.
"It is an investigational molecule and cannot legally be sold to the public. It has not been reviewed or approved by any regulatory agency in the world. No one should consider taking anything claiming to be retatrutide outside of a Lilly-sponsored clinical trial. The company continues to warn the public about the potential dangers of fake medicines.
Topics: Weight loss, Drugs, Mounjaro, US News, Health
Mia Williams