The decision comes after STAT revealed that the company had provided the unapproved medication to an anonymous 79-year-old adult through a “compassionate use” pathway allowed by the U.S. Food and Drug Administration (FDA).
This doesn’t mean retatrutide is now broadly available to the public. The once-weekly injection, which targets three hormone receptors in the body — GLP-1, GIP, and glucagon — is still in clinical trials, and FDA approval isn’t expected until sometime next year.
Retatrutide Has Produced Unprecedented Weight Loss in Trials
Interest in early access to retatrutide is high because the drug has produced striking weight loss in studies. “We are all eagerly awaiting FDA approval of retatrutide, which has shown unprecedented weight loss results in clinical trials,” says Sun Kim, MD, an associate professor of medicine and an endocrinologist at Stanford Health Care in California.
In phase 3 results released by Lilly, people who took the highest dose of retatrutide lost 25 percent of their starting weight on average, over 80 weeks, when the analysis included participants who dropped out of the study early. In an analysis estimating the effect on only the participants who remained on treatment, average weight loss reached 28.3 percent.
How Does the FDA Define ‘Compassionate Use,’ and Who Might Qualify?
Expanded access, also called compassionate use, allows someone with a serious or life-threatening condition to receive an experimental drug outside a clinical trial. The FDA says compassionate use may be considered when:
- There is no satisfactory treatment for the patient’s condition.
- The person cannot join a trial.
- The possible benefit justifies the risks.
- Providing the drug will not interfere with its development.
“Compassionate use is an important pathway for patients with life-threatening conditions such as advanced cancer or severe infectious diseases, but the application process is complex and time-consuming,” says Dr. Kim.
While obesity is associated with major health risks, its complications are generally less immediate, making compassionate use more difficult to justify under current standards, she says.
According to Lilly, to qualify for retatrutide through its compassionate use program, a person must:
- Be age 18 or older.
- Be unable to participate in a clinical trial.
- Have refractory obesity.
- Have at least two serious obesity-related complications.
- Have discussed all standard treatment options with a doctor.
Refractory obesity means that sufficient weight loss hasn’t occurred despite lifestyle changes and treatment, says Yuval Pinto, MD, an obesity and family medicine doctor at Johns Hopkins Medicine in Baltimore. Serious complications could include type 2 diabetes, high blood pressure, heart disease, heart failure, or certain heart rhythm disorders, he says.
Kim points out that one part of the criteria remains unclear: What does it mean to have “discussed” all standard options?
“Does this simply mean that available treatments have been reviewed with the patient, or does it require that they have actually tried them?” Kim asks. “If it is the latter, would patients also be expected to undergo — or be deemed ineligible for — bariatric surgery before qualifying? Clear guidance would be helpful.”
Only One U.S. Clinical Trial for Retatrutide Is Currently Recruiting
While studies on retatrutide are still ongoing, the ones currently enrolling participants are not general obesity trials. As of August 4, 2026, ClinicalTrials.gov listed only one retatrutide trial recruiting participants, for people with high-risk metabolic dysfunction-associated steatotic liver disease, the condition formerly known as nonalcoholic fatty liver disease.
“Clinical trials aren’t available in every region, leaving some patients with no realistic path to access the drug before approval,” Kim says. Even when a trial is available, a person may not meet its requirements, or they may be randomly assigned to receive a placebo (dummy drug).
How to Apply for Compassionate Use
Patients cannot apply directly to Lilly for compassionate use of retatrutide. A treating doctor must support the request and contact the drugmaker. If Lilly agrees to supply the drug, authorization from the FDA and an institutional review board would also be required.
Lilly’s general expanded-access policy says that it will respond within five business days after receiving the required medical information, although the doctors interviewed by STAT described delays and little clarity about the process.
Should You Ask Your Doctor About Compassionate Use Retatrutide?
It may be reasonable to ask for compassionate use retatrutide if you have severe obesity with serious complications, have tried available treatments without enough improvement, and cannot join an appropriate clinical trial.
“If I had tried everything and nothing helped, then yes, I would consider it as a last resort,” Dr. Pinto says. “But it wouldn’t be my first choice, because retatrutide isn’t FDA-approved.”
Some doctors interviewed by STAT questioned whether Lilly would provide meaningful access beyond a small number of exceptional cases. Others said that they wanted more safety data before using retatrutide outside of the close monitoring of a clinical trial.
Lilly has not said how many requests it will approve, how long treatment would continue, or who would pay for related monitoring and care. That leaves a substantial gap between being potentially eligible and actually receiving the medication.
“I don’t see compassionate use as a viable option for retatrutide for the majority of patients,” says Kim.
Compounded Retatrutide Remains Illegal (and Risky)
Kim points out that some people are already obtaining retatrutide through unapproved channels like compounding pharmacies — a decision that comes with significant risks.
These products may contain the wrong amount, contaminants, or a different ingredient. Selling compounded retatrutide is also illegal. For these reasons, people should avoid products sold online as compounded or “research” retatrutide.
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