Eli Lilly will allow more patients to seek access to retatrutide, its experimental triple-agonist weight-loss drug, through an expanded compassionate use program, STAT News reported on August 3 (STAT). The move comes weeks after STAT revealed that the company provided the unapproved medication to one anonymous 79-year-old patient — reported to be former President Donald Trump — through the FDA’s compassionate use pathway (we covered that story here).
Who qualifies
According to Lilly, a patient must:
- Be at least 18 years old
- Be unable to participate in a clinical trial
- Have refractory obesity — meaning insufficient weight loss despite lifestyle changes and treatment
- Have at least two serious obesity-related complications, such as type 2 diabetes, high blood pressure, heart disease, heart failure, or certain heart rhythm disorders
- Have discussed all standard treatment options with a doctor
The criteria were first reported by STAT and summarized by Everyday Health and KFF Health News (Everyday Health; KFF Health News).
What’s still unclear
Clinicians quoted by STAT and Everyday Health note the gaps: Lilly has not said how many requests it will approve, how long treatment would continue, or who would pay for monitoring and care. Exactly what “discussed all standard treatment options” means — reviewed versus actually tried — is also unspecified, Stanford endocrinologist Sun Kim told Everyday Health. “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,” she said.
“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,” Kim added. “I don’t see compassionate use as a viable option for retatrutide for the majority of patients.”
The process is physician-driven: patients cannot apply directly. A treating doctor must contact Lilly, and authorization from the FDA and an institutional review board is required. Lilly’s general expanded-access policy says it responds within five business days of receiving the required medical information.
A drug still in trials
Retatrutide remains unapproved worldwide, and Lilly’s FDA filing is expected in the first quarter of 2027. As of August 4, only one retatrutide trial in the United States was recruiting participants — a study in metabolic dysfunction-associated steatotic liver disease — leaving many patients with no realistic trial pathway. Meanwhile, compounded or “research” retatrutide sold online remains illegal and potentially dangerous, and regulators on both sides of the border have warned against it (FDA: unapproved GLP-1 drugs).
Canadian context
Lilly’s expanded access program is a U.S. pathway: Canadian patients cannot apply directly. The Canadian analogue remains Health Canada’s Special Access Programme (SAP), which permits a physician to request an unapproved drug for a specific patient with a serious or life-threatening condition — historically used far more restrictively than U.S. expanded access (how to get retatrutide in Canada).
The practical takeaway for Canadians is unchanged: the realistic pathways to retatrutide are clinical trial enrollment at Canadian sites or, in exceptional cases, an SAP request — not the compassionate use headlines, and certainly not anything sold online. If a seller invokes “compassionate use” in an advertisement, that is a red flag: no legitimate compassionate-use retatrutide is available for purchase anywhere (black market warnings).
Sources
- STAT: Eli Lilly to allow more patients to apply for special access to unapproved obesity drug (August 3, 2026)
- Everyday Health: Drugmaker to Offer Early Access to Experimental GLP-1 Retatrutide (August 4, 2026)
- KFF Health News: Eli Lilly Opens Compassionate Use Pathway for Patients Needing Experimental Obesity Drug (August 4, 2026)
- FDA: Expanded Access
- FDA: FDA’s concerns with unapproved GLP-1 drugs used for weight loss
Disclaimer: GetRetatrutide.ca is an independent educational resource. This article does not constitute medical advice. Retatrutide is not approved by Health Canada or the FDA.