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Pre-approval Expanded Access of Retatrutide (LY3437943)

Pre-approval Expanded Access of Retatrutide (LY3437943)

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT07629401
Enrollment
Unknown
Registered
2026-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Obesity-related Complications

Keywords

Retatrutide, LY3437943, Expanded Access

Brief summary

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.

Detailed description

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.

Interventions

DRUGRetatrutide

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Contacts

CONTACTPhysician Inquiries for Lilly Clinical Trial Information:
ClinicalTrials@lilly.com1-800-LillyRx (1-800-545-5979)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026