Retatrutide Expanded Access: Who Qualifies and How Doctors Apply

The question this site’s readers ask more than any other is some version of “how do I get retatrutide before it is approved?” Until this summer the only honest answer was a clinical trial. Since August 2026 there is a second, much narrower route: Eli Lilly’s pre-approval expanded access program, registered on ClinicalTrials.gov as NCT07629401. This article sets out what the program is, who it is for, and how a request is made, using the wording of the registry record rather than second-hand summaries.

Two things first. Expanded access is not a way around the eligibility rules; it is a mechanism for a small number of very sick patients who have run out of approved options. And patients cannot apply. Only a treating physician can.

What the program is

Expanded access (often called “compassionate use”) is an FDA pathway that lets a manufacturer provide an investigational drug outside a clinical trial to a patient with a serious condition who has no comparable alternative and cannot join a trial. The physician takes responsibility for the treatment, the FDA reviews the request, and an institutional review board (IRB) must approve it.

Lilly’s record describes the retatrutide program as single-patient expanded access: each request is assessed individually. The record was first posted on June 5, 2026, updated on August 6, 2026, and shows a status of Available. Reporting by STAT News on August 3, 2026 described how the program came to light: a single patient had received retatrutide on a compassionate basis some weeks earlier, other physicians began asking for the same, and Lilly confirmed it was “actively reviewing requests from health care providers”. Lilly’s statement to STAT: “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.”

Who qualifies

The registry lists the criteria as follows. All of them must be met.

Inclusion criteria

1. Age 18 years or older.
2. Refractory obesity, defined as a BMI of 35 kg/m² or higher despite adherence to and tolerance of treatment with the highest available dose of a chronic weight management therapy. In practice that means the patient has already taken a maximum dose of an approved drug such as tirzepatide (Zepbound), semaglutide (Wegovy) or orforglipron (Foundayo), stayed on it, tolerated it, and still has a BMI of 35 or more.
3. Two or more serious or life-threatening obesity-related complications for which the patient is currently receiving standard-of-care treatment.
4. Unable to participate in an ongoing clinical trial of retatrutide or a similar investigational medicine, either because the patient does not meet the trial’s eligibility criteria or because there is no reasonably accessible enrolling site.
5. All standard treatment options, including bariatric surgery, discussed with the patient through shared decision-making.

Exclusion criterion

• Any medical contraindication to retatrutide therapy.

The record adds that availability “will depend on geography, product supply, and detailed individual eligibility assessment”. Meeting every criterion does not guarantee that Lilly will supply the drug.

What the criteria rule out

Read plainly, the program excludes most people who ask about it:

• Anyone with a BMI under 35, regardless of how much weight they want to lose.
• Anyone who has not first tried and stayed on the top dose of an approved obesity medication.
• Anyone with fewer than two serious obesity-related complications under active treatment.
• Anyone who could enroll in a retatrutide trial, or a comparable trial of another investigational drug, at a site they can reasonably reach.
• Anyone who has not had bariatric surgery raised as an option.

It is also not a route for type 2 diabetes alone, sleep apnea alone, or knee osteoarthritis alone; the program is framed around severe, refractory obesity.

How a request is made

The request is initiated by the treating physician on behalf of the patient. The registry record is explicit that “patients and caregivers should be directed to their treating physician rather than contacting Lilly directly.”

The steps, from the record and from FDA’s standard expanded-access process:

1. The physician confirms the patient meets every criterion above and documents that no suitable trial is accessible (ClinicalTrials.gov lists the current retatrutide trials).
2. The physician contacts Lilly through the Lilly Answers Center at 1-800-LillyRx (1-800-545-5979), or by email at ClinicalTrials@lilly.com, and presents the case.
3. If Lilly agrees to supply the drug, the physician submits an individual patient expanded access request to the FDA (Form FDA 3926) and obtains IRB approval.
4. The patient gives informed consent, and the physician manages treatment and reports adverse events.

Reporting after the program was confirmed (Noom, August 20, 2026, citing Lilly’s statements to STAT) said Lilly aims to respond to physician inquiries within five business days. That figure is not in the registry record and we have not verified it with Lilly.

What this program is not

It is not a supply of the black-market product. Lilly’s August 12, 2026 statement on illegal retatrutide sales makes the distinction: the company’s chief medical officer called black-market retatrutide “entirely unverified, unapproved and not worth the risk”. Expanded access supplies the clinical-trial product under medical supervision; it has nothing in common with vials bought online. See Why You Can’t Safely Buy Retatrutide Online.

It is not a preview of the approval. Expanded access decisions are made case by case and say nothing about when or whether the FDA will approve retatrutide. Lilly’s stated plan is a Biologics License Application in the first quarter of 2027.

It is not free of trade-offs. Expanded access patients receive an investigational drug whose full safety profile is still being characterised, including dysesthesia in 6–21% of participants at the 12 mg dose across the four TRIUMPH trials, without the monitoring infrastructure of a trial. Physicians weighing a request should read the safety overview and the TRIUMPH-3 cardiovascular data.

For patients: what to do with this information

If you believe you meet the criteria, the useful action is to bring this article and the ClinicalTrials.gov record (NCT07629401) to the physician who manages your obesity or its complications, and ask whether they would consider making a request. If you do not meet the criteria, which will be most readers, the options are the ones that existed before: a retatrutide clinical trial if one is enrolling near you (our Find a Trial page lists the studies still recruiting and their sites), or an approved therapy now.

Key facts

• Program: Pre-approval Expanded Access of Retatrutide (LY3437943), ClinicalTrials.gov NCT07629401, sponsor Eli Lilly, status Available (verified August 2026).
• Type: single-patient (individual) expanded access.
• Core criteria: age 18+; BMI ≥35 despite the highest dose of an approved weight-management therapy; two or more serious obesity-related complications under treatment; no accessible trial; bariatric surgery discussed.
• Who applies: the treating physician, via 1-800-LillyRx (1-800-545-5979). Patients cannot apply directly.
• Guarantee: none. Supply depends on geography, product availability and individual assessment.