Eli Lilly offers new weight loss drug to some patients before FDA approval

Eli Lilly will allow a limited number of patients early access to retatrutide, its next-generation weight loss drug, before it gets FDA approval. 

The company confirmed the news to Reuters. 

Retatrutide early access

What they're saying:

"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 company ⁠spokesperson told Reuters. 

Who's Eligible:

Patients must be aged 18 or older, have treatment-resistant obesity and have at least ​two serious or life-threatening obesity-related complications. They also have to be unable to participate in retatrutide clinical trials or other comparable treatments. 

RELATED: Doctors warn rapid weight loss from popular medications can cause back pain

According to STAT News, the move comes after Lilly granted a 79-year-old patient exclusive access to the drug, prompting doctors to ask for an expanded early-access program. 

What is retatrutide? 

Big picture view:

Retatrutide is the next step in the class of drugs known as GLP-1s. Retatrutide is a first-of-its kind triple agonist, meaning it mimics three different hormones that regulate appetite and metabolism.  Zepbound and Mounjaro, Eli Lilly’s other blockbuster weight loss drugs, are dual agonists, while Novo Nordisk’s Wegovy and Ozempic are singular agonists. 

RELATED: Retatrutide, Eli Lilly's next obesity drug, fueled dramatic weight loss in clinical trial

Lilly announced the clinical trial results in a news release in May, though they haven’t been peer-reviewed or published in a medical journal. 

By the numbers:

According to Eli Lilly, the trial included 2,339 patients who were obese or overweight. Participants on the highest dose lost just over 70 pounds on average, or 28.7% of their body weight, after 80 weeks. 

RELATED: New GLP-1 drugs could suppress desire for more than just food, study suggests

For patients with a body mass index (BMI) of over 35, the heaviest people in the trial, the weight loss was even higher: They lost an average of 85 pounds, or 30.3% of their body weight, after two years. According to The New York Times, that’s on par with patients who have gastric bypass surgery. 

Clinical trial participants who took Zepbound lost an average of 50 pounds over 72 weeks, while those who took semaglutide, or Wegovy, lost about 33 pounds.

Retatrutide for pain

Lilly also reported that trial participants saw "substantial relief" from osteoarthritis pain, another sign that these blockbuster drugs are treating more than obesity. Zepbound is FDA-approved to treat sleep apnea, while Wegovy is FDA-approved to treat heart disease. These drugs are also being studied to potentially treat alcohol and substance use disorders. 

What they're saying:

"People with obesity and knee osteoarthritis often live with pain and restricted mobility, and may eventually require total joint replacement," Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said in a statement in May. "We are encouraged by the results … which highlight the powerful effect of retatrutide, a first-in-class triple agonist, on body weight, pain and physical function. We believe retatrutide could become an important option for patients with significant weight loss needs and certain complications, including knee osteoarthritis."

Retatrutide side effects

Dig deeper:

With more weight loss also came more side effects, like nausea, vomiting, diarrhea and constipation, Lilly reported. The company said 11% of participants on the highest dose left the study because of side effects. That’s a higher dropout rate than previous clinical trials for other obesity drugs. 

When will retatrutide hit the market? 

What's next:

Eli Lilly hasn’t released a date for when it will seek approval by the Food and Drug Administration. The company said it has more retatrutide trials planned this year.

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