Pre-approval Expanded Access of Retatrutide (LY3437943)
August 3, 2026 updated by: Eli Lilly and Company
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.
Study Overview
Status
Available
Conditions
Intervention / Treatment
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.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 1, 2026
First Submitted That Met QC Criteria
June 1, 2026
First Posted (Actual)
June 5, 2026
Study Record Updates
Last Update Posted (Actual)
August 6, 2026
Last Update Submitted That Met QC Criteria
August 3, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27979
- J1I-MC-Y001 (Registry Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.