Could Retatrutide Be The Next Ozempic?

A new weight loss medication called retatrutide is drawing attention, though it hasn’t yet been approved by the FDA. Early studies show promising results, with the potential to help people lose a significant amount of weight. Developed by Eli Lilly, retatrutide is a triple-hormone receptor agonist, meaning it targets three key hormones involved in regulating hunger and metabolism: GIP (gastric inhibitory peptide), GLP-1 (glucagon-like peptide-1), and GCG (glucagon). These hormones help control appetite, regulate insulin production, and manage blood sugar, all of which can aid in weight loss.

Testing shows positive results so far.

In clinical trials, retatrutide has shown impressive results. In the TRIUMPH-4 trial, participants using the 12 mg dose lost an average of 71.2 lbs (32.3 kg) over 68 weeks. This study involved adults with obesity or those who were overweight and had knee osteoarthritis, without diabetes. Participants were given retatrutide along with a healthy diet and exercise plan. Results from other studies also show substantial weight loss, with some participants losing up to 24.2% of their body weight after 48 weeks of treatment, according to Drugs.com.

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In a 2023 Phase 2 clinical trial, which was published in the New England Journal of Medicine, retatrutide was tested on adults with a BMI of 30 or higher, or those with a BMI of 27 to less than 30 along with weight-related conditions. Participants were randomly assigned to receive different doses of retatrutide or a placebo. At 24 weeks, those who took the higher doses of retatrutide (8 mg and 12 mg) lost a significant amount of weight, with the 12 mg group showing a 17.5% reduction in body weight, compared to just 1.6% in the placebo group. After 48 weeks, weight loss in the 12 mg group reached 24.2%, showing that the drug could lead to substantial, sustained weight reduction.

What are the side effects of retatrutide?

The most common side effects of retatrutide were gastrointestinal, including nausea and vomiting, which were generally mild to moderate. These side effects were more common in participants taking higher doses, but they were partially alleviated by starting with a lower dose. There were also small increases in heart rate, which peaked at 24 weeks but decreased afterward. Despite these side effects, the results of the trials suggest that retatrutide could be an effective tool for weight loss, especially for those struggling with obesity.

It’s not FDA approved just yet.

Now, take that information with caution. Although retatrutide shows strong promise, it’s important to note that it’s not yet available for general use. Eli Lilly has not yet submitted the trial data to the FDA for approval, meaning it is still considered an experimental drug. 

“People should wait to take medications until they are approved by the FDA to maximize safety,” Richard Siegel, MD, co-director of the Diabetes and Lipid Center at Tufts Medical Center and endocrinologist at Tufts Medicine Weight & Wellness Center–Stoneham, told SELF in an interview published April 14. “All scientific data in animals initially and then humans are carefully reviewed by the FDA for any signals that a medication may be harmful.”

Currently, the only way to access it is through participation in clinical trials, but some pharmacies have been selling the drug online. The FDA issued a cautionary press release in February warning people to steer clear of the drug until it has been approved. 

“FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss,” the press release read in part. “This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed.”

The agency also warned that some versions of retatrutide being sold right now may be fraudulent or improperly stored, particularly the injectable form of the drug. Compounded drugs should only be used for patients whose medical needs cannot be addressed by an FDA-approved medication.

There is no set timeline for when the drug will be available to the public, so those interested in it should keep an eye out for updates. 

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