Pre-approval Expanded Access of Retatrutide (LY3437943)

Pre-approval Expanded Access of Retatrutide (LY3437943)

Provide pre-approval single-patient expanded access of retatrutide (LY3437943), an investigational GLP-1/GIP/glucagon triple receptor agonist being studied for chronic weight management, for adults with severe obesity (body mass index [BMI] greater than or equal to [≥]35 kilogram per square meter [kg/m²] and at least two serious or life-threatening obesity-related complications who are refractory to the best approved therapy and are unable to participate in an ongoing clinical trial of retatrutide or a comparable investigational medicine.

Treating physicians who believe an individual patient may be a candidate for expanded access should contact Lilly via the Lilly Answers Center at 1-800-LillyRx (1-800-545-5979). 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. Availability will depend on geography, product supply, and detailed individual eligibility assessment, to ensure consistent application of the general eligibility criteria listed above.

All of the following criteria must be met:

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Medical contraindication to retatrutide therapy