Retatrutide FDA Approval Tracker

Current Regulatory Status: Investigational Compound

Retatrutide (development code LY3437943) is an investigational drug and is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory body. Developed by Eli Lilly and Company, retatrutide functions as a GLP-1 / GIP / Glucagon receptor agonist. The compound remains under active clinical investigation and is not commercially available or approved for prescription use. For ongoing tracking of regulatory milestones, reference the [FDA Approval Tracker](/retatrutide/fda-approval).

Because retatrutide is investigational, its clinical profile continues to be assessed across multiple global Phase 3 clinical trials evaluating various metabolic, cardiovascular, renal, and musculoskeletal endpoints.

Phase 3 Clinical Trial Architecture

Eli Lilly and Company is evaluating retatrutide across two primary clinical trial programs: the TRIUMPH series (evaluating obesity, overweight, and associated complications) and the TRANSCEND series (evaluating type 2 diabetes). These trials assess the drug across diverse patient cohorts, ranging from primary weight management to major cardiovascular and renal outcomes.

The table below details the Phase 3 clinical trials registered for retatrutide:

Completed Phase 3 Trials and Reported Findings

Several studies in the Phase 3 clinical evaluation program have reached completed recruitment and study milestones:

• TRIUMPH-1 (NCT05929066): Enrolled 2,335 participants with obesity, overweight, knee osteoarthritis, or obstructive sleep apnea. Primary endpoints include percent change from baseline in body weight, change from baseline in Apnea-Hypopnea Index (AHI) events per hour for the GSA1 subset, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score for the GOA1 subset, and percent change in body weight in the extension subset.
• TRIUMPH-4 (NCT05931367): Enrolled 445 participants with obesity, overweight, and knee osteoarthritis. Primary endpoints evaluated change in WOMAC pain subscale score and percent change in body weight compared to placebo.
• TRANSCEND-T2D-1 (NCT06354660): Enrolled 537 participants with type 2 diabetes with inadequate glycemic control on diet and exercise alone, measuring change from baseline in Hemoglobin A1c (HbA1c) (%) against placebo.

In addition to trial registry milestones, regulatory and corporate announcements have detailed Phase 3 study findings. On July 23, 2026, Eli Lilly reported Phase 3 results from the TRIUMPH-2 and TRIUMPH-3 trials. In TRIUMPH-2, adults with obesity or overweight and type 2 diabetes lost up to an average of 49.6 lbs (20.8%) at 80 weeks. In TRIUMPH-3, the trial evaluated adults with severe obesity and established cardiovascular disease, with or without type 2 diabetes. Subsequent pipeline progress and financial results were highlighted in the company's second-quarter results on August 5, 2026.

Active Phase 3 Studies and Completion Timelines

Multiple registration-enabling and outcome studies remain active:

• TRIUMPH-Outcomes (NCT06383390): The largest study in the program, enrolling 10,000 adults living with obesity and atherosclerotic cardiovascular disease or chronic kidney disease. Its primary endpoints assess time to first occurrence of composite cardiovascular endpoints, as well as composite endpoints of End Stage Kidney Disease (ESKD), sustained decline of ≥40% in estimated glomerular filtration rate (eGFR), CV death, or renal death. The study began on April 30, 2024, with a primary completion date scheduled for February 1, 2029.
• TRANSCEND-T2D-2 (NCT06260722): An active comparative study of 1,250 participants evaluating retatrutide against semaglutide in type 2 diabetes, measuring change in HbA1c with a primary completion date of August 1, 2026.
• TRIUMPH-5 (NCT06662383): An active trial of 800 participants evaluating retatrutide against tirzepatide for percent change in body weight, with a primary completion date of November 1, 2026.
• TRIUMPH-7 (NCT07035093): Enrolling 586 participants with obesity, overweight, and chronic low back pain, assessing pain intensity per numeric rating scale and body weight change, with primary completion expected in September 2027.
• TRIUMPH-9 (NCT07357415): A trial of 600 participants living with obesity or overweight measuring percent change in body weight, initiated on January 24, 2026, with primary completion targeted for October 1, 2028.

Additional updates and contextual reporting on trial readouts can be tracked through our [News & Analysis](/news) desk.

Regulatory Enforcement and Black Market Actions

Due to its unapproved, investigational status, retatrutide cannot be legally marketed, compounded, or distributed for clinical use outside authorized clinical trials. On August 12, 2026, Eli Lilly and Company issued a regulatory update calling on online platforms, payment processors, and regulatory agencies to shut down illegal retatrutide black markets, filing six new lawsuits in the United States against black market entities.

Sources

• ClinicalTrials.gov Identifier NCT06383390 (TRIUMPH-Outcomes)
• ClinicalTrials.gov Identifier NCT07357415 (TRIUMPH-9)
• ClinicalTrials.gov Identifier NCT05929066 (TRIUMPH-1)
• ClinicalTrials.gov Identifier NCT05931367 (TRIUMPH-4)
• ClinicalTrials.gov Identifier NCT06662383 (TRIUMPH-5)
• ClinicalTrials.gov Identifier NCT06260722 (TRANSCEND-T2D-2)
• ClinicalTrials.gov Identifier NCT06354660 (TRANSCEND-T2D-1)
• ClinicalTrials.gov Identifier NCT07035093 (TRIUMPH-7)
• Eli Lilly and Company Regulatory Announcement (2026-07-23): *Lilly's triple agonist, retatrutide, successful in two additional Phase 3 obesity trials, delivering significant improvements in weight and A1C*
• Eli Lilly and Company Financial Results (2026-08-05): *Lilly reports second-quarter 2026 financial results, raises full-year guidance, and highlights continued growth and pipeline progress*
• Eli Lilly and Company Regulatory Update (2026-08-12): *Lilly calls on online platforms, payment companies and regulators to shut down the illegal retatrutide black market*