Approved

Retatrutide: Research Status, Trials, and Mechanism

Registered trials34

Regulatory status

Retatrutide does not have an approved drug label. It remains an investigational compound under clinical study, and no indications, dosing, or safety information have been formally approved by regulators for public use.

What retatrutide is

Retatrutide is a peptide compound currently being studied in clinical trials. Because no approved label exists, details on its mechanism of action and drug classification cannot be confirmed from official labeling data at this time.

Trial footprint

Retatrutide has 34 registered clinical trials. Among these, a Phase 3 study (NCT06383390) is evaluating cardiovascular and kidney outcomes in adults with obesity and is active but not recruiting. Another Phase 3 trial (NCT06260722) is comparing retatrutide with semaglutide in adults with type 2 diabetes who have inadequate glycemic control on metformin, with or without an SGLT2 inhibitor, and is also active but not recruiting. A Phase 1 study (NCT06982859) is examining retatrutide's effects on insulin secretion and insulin sensitivity in adults with type 2 diabetes mellitus.

FAQ

Is retatrutide FDA approved?
No. Retatrutide does not currently have an approved drug label. It remains under clinical investigation, and no indications or uses have been formally approved.
What is retatrutide being studied for?
Registered trials are examining retatrutide in adults with obesity, looking at cardiovascular and kidney outcomes, and in adults with type 2 diabetes, including comparisons with other treatments and effects on insulin secretion and sensitivity.
How many clinical trials involve retatrutide?
There are 34 registered clinical trials involving retatrutide. These span different stages of clinical research, including both early-phase and later-stage studies.
Are there any Phase 3 trials for retatrutide?
Yes. At least two Phase 3 trials are listed, one evaluating cardiovascular and kidney outcomes in adults with obesity, and another comparing retatrutide to semaglutide in adults with type 2 diabetes. Both are currently active but not recruiting new participants.
Can retatrutide be used outside of a clinical trial?
Because retatrutide has no approved label, there is no established, regulator-approved use outside of clinical trial settings. Any use would fall outside of approved medical guidance.
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Sources: ClinicalTrials.gov DailyMed

Updated 2026-11-07