Obese patients who struggle to slim down on today’s blockbuster weight-loss shots are set to be offered retatrutide, an experimental drug that helped patients lose up to a quarter of their body weight in clinical trials.
The move comes amid growing concern over a black market for the experimental drug, known by some users as ‘reta’, which is yet to receive FDA approval.
Regulators have warned that unapproved versions sold online may pose serious health risks.
Last night Eli Lilly, the pharmaceutical company that produces the shot, announced a limited number of patients can apply for early access to its latest weight loss shot, ahead of it being given the green light by the regulator.
Retatrutide, dubbed ‘exercise in a jab,’ is known as a triple agonist because it targets three hormone receptors to help users lose weight – compared to Ozempic’s one and Mounjaro’s two.
‘For a limited number of patients who meet specific medical criteria and cannot enroll in a clinical trial, we believe it is medically appropriate to make authentic retatrutide available before FDA approval, consistent with FDA’s guidance,’ a Lilly spokesperson told STAT News.
The spokesperson added that Lilly has built an expanded access program ‘that does that and are actively reviewing requests from health care providers.’
Eligible patients must be 18 or older, have obesity that has failed to respond to the highest approved dose of weight-loss medication they can safely take, and have at least two serious obesity-related health conditions.
Retatrutide is an appetite-suppressing medication like Mounjaro and Ozempic – but unlike those drugs it is still undergoing clinical trials
Demand for the experimental weight loss jab has surged, with some users accessing it through the black market.
These versions of the unapproved weight loss drug, often from China, have reportedly been sold through influencers and beauty clinics in the US.
Health officials and Eli Lilly have warned repeatedly that these jabs may not be safe to use and that there is no way of knowing that they actually contain retatrutide and do not contain impurities.
In December 2023, a British mother nearly died after injecting herself with a weight loss drug she bought online. Tests later revealed it was a synthetic version of insulin, a hormone that helps to lower blood sugar. The injection caused her blood sugar to crash to potentially fatal low levels.
A spokesman for Eli Lilly said: ‘Any claim that black market retatrutide is the same as Lilly’s genuine medicine as studied in clinical trials is false.’
The FDA sent warning letters to sellers of unapproved drugs warning against marketing medications that had not been cleared for sale in the US.
Eli Lilly is currently conducting phase three of its trial on retatrutide, testing the drug’s effectiveness for a slew of medical conditions including obesity, type 2 diabetes, knee osteoarthritis pain, and sleep apnea, per the company’s website.
Early results from the trial, published on July 23, showed the drug helped patients achieve major weight loss. After 80 weeks, adults with severe obesity and heart disease lost an average of 55.8 lbs.
In 2023, phase two results showed those with obesity and type 2 diabetes who used the drug lost up to 49.6 lbs after the 80 weeks.
Many patients with obesity or overweight-related conditions turn to GLP-1 medications as part of their treatment plan. An estimated 31 million Americans takes one of these drugs to lose weight (stock)
After completing the trials, the company plans to file for approval of retatrutide with the FDA in the first quarter of 2027.
The move comes after Eli Lilly and the FDA granted a 79-year-old man access to the drug through the agency’s ‘compassionate use’ program, which allows patients with serious, life-threatening conditions to try experimental treatments, STAT News initially reported.
The single-patient request listed his symptoms, including severe obesity, obstructive sleep apnea, and pulmonary hypertension, and drew attention from health officials.
Some have speculated the patient was President Trump, who recently turned 80 and has previously voiced interest in weight loss drugs – though the identity has not been confirmed.
White House spokesperson Kush Desai posted on X that the commander-in-chief was not the 79-year-old patient.
