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Retatrutide-Obesity
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.
Is there an expanded access program for retatrutide?
Lilly is supporting requests for expanded access to retatrutide for individual patients who meet eligibility criteria. Availability will depend on geography, product supply, and a detailed individual eligibility assessment.
What are the details of the expanded access program for retatrutide?
Retatrutide is an investigational glucose insulinotropic polypeptide receptor (GIPR)/glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) agonist being studied for chronic weight management.1 Retatrutide is not currently approved by the US Food and Drug Administration (FDA).
In rare situations, when individuals cannot join a clinical trial and have exhausted all available medical options, Lilly may provide investigational medicine in coordination with a requesting physician as expanded access.2
Expanded access to retatrutide will end after potential FDA approval and commercial availability.
Expanded Access of Retatrutide (NCT07629401)
Retatrutide may be provided as part of this pre-approval single-patient expanded access.1
For patients to be considered all the following inclusion criteria must be met:
- Age 18 years or older.
- Refractory obesity, defined as BMI ≥ 35 kg/m2 despite adherence to and tolerance of treatment with highest available dose of chronic weight management therapy.
- Two or more serious or life-threatening obesity-related complications for which the patient is currently receiving standard of care.
- Unable to participate in an ongoing clinical trial of retatrutide or a similar/comparable investigational medicine (due to trial eligibility criteria or lack of a reasonably accessible enrolling site).
- All standard treatment options including bariatric surgery discussed with the patient through shared decision-making.1
Patients with a medical contraindication to retatrutide are excluded.1
What is the process to request retatrutide expanded access?
Requests are initiated by the treating physician on behalf of the patient; patients and caregivers should be directed to their treating physician rather than contacting Lilly directly.1
Availability will depend on geography, product supply, and detailed individual eligibility assessment, to ensure consistent application of the general eligibility criteria listed above.1
After reviewing this information if a treating physician believes an individual patient may be a candidate for expanded access they should contact Lilly via the Lilly Answers Center (TLAC) at 1-800-LillyRx (1-800-545-5979).1
Lilly evaluates expanded access requests on a case-by-case basis.
If the information provided by the treating physician meets the initial criteria, Lilly medical will provide a detailed intake form for further evaluation. Approved expanded access requests will require the treating physician to:
- complete a letter of agreement.
- apply to the local regulatory agency (eg FDA) as the sponsor (eg applying physician for the patient specific investigational new drug [IND] for expanded access). The physician must have the capability to manage the retatrutide aligned with Good Clinical Practices. The sponsor must ensure the receipt, storage (in a temperature controlled secure location), dispensing, patient returns, and final destruction or return to Lilly. Direct to patient shipping is not available from Lilly.
- obtain institutional review board (IRB) approval.
- follow all local regulations including adverse event reporting and a final report.3
What is the cost of retatrutide provided through the expanded access program?
Lilly provides products at no cost through the expanded access program.4
Is there any information available on executing an expanded access program?
The following websites may be helpful to physician to understand expanded access including the role and responsibility of the physician:
- U.S. Food & Drug Administration: Expanded Access, Information for Physicians
- Reagan-Udall Foundation for the Food and Drug Administration: For Physicians and Healthcare Providers
References
- Pre-approval expanded access of retatrutide (LY3437943). NCT07629401. Clinicaltrials.gov. Last updated August 6, 2026. Accessed August 11, 2026. https://clinicaltrials.gov/study/NCT07629401
- Eli Lilly and Company Expanded Access website. Accessed August 11, 2026. https://www.lilly.com/science/clinical-trials/expanded-access
- U.S. Food and Drug Expanded Access, Information for Physicians. Accessed August 11, 2026. https://www.fda.gov/news-events/expanded-access/expanded-access-information-physicians
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: August 26, 2026