Retatrutide
Retatrutide (GLP-1/GIP/GCGR Triple Receptor Agonist)
Evidence & Status
- Strong Human Evidence
- Strong
At a Glance
An investigational triple hormone receptor agonist targeting GLP-1, GIP, and glucagon receptors. Published Phase II trials reported findings in obesity and type 2 diabetes; Phase III TRIUMPH-1 is completed and TRIUMPH-Outcomes is active not recruiting, without posted results identified in this audit.
Plain English
Researchers study Retatrutide because it simultaneously activates three hormone pathways involved in metabolic regulation — GLP-1, GIP, and glucagon receptors. Published Phase II trials investigated obesity and type 2 diabetes. Its Phase III program includes completed TRIUMPH-1 and active-not-recruiting TRIUMPH-Outcomes; the registry status of those studies does not by itself establish treatment efficacy. Retatrutide remains investigational and is not FDA-approved.
Overview
Retatrutide (LY3437943) is an investigational triple agonist of the GIP, GLP-1, and glucagon receptors. Verified human evidence in this record consists of controlled Phase II obesity and type 2 diabetes studies. It remains investigational and is not FDA-approved; trial findings and any future Phase III results must remain tied to their specific population, protocol, and primary source.
Research Summary
Retatrutide has published controlled human Phase II evidence in obesity and type 2 diabetes while it remains investigational. Phase III TRIUMPH-1 (NCT05929066) is completed; TRIUMPH-Outcomes (NCT06383390) is active not recruiting, with no posted results identified in this audit. Registry records support trial status and design only, not efficacy conclusions. No FDA-approved indication or approved dosing exists.
Research Areas
- Investigational obesity research
- Investigational type 2 diabetes research
Safety & Risks
Serious Risks
- Long-term human safety and clinical outcomes remain incompletely characterized; not approved for use outside clinical trials
Reported Side Effects
- Nausea
- Vomiting
- Diarrhea
- Decreased appetite
- Constipation
- Injection site reactions
- Elevated heart rate (dose-dependent)
- Decreased lean mass at highest doses
Legal Status by Region
- United States
- Investigational; Phase III TRIUMPH-1 (NCT05929066) is completed and TRIUMPH-Outcomes (NCT06383390) is active not recruiting; no FDA-approved form
- United Kingdom
- Current authorization status not established in this record
- Australia
- Current authorization status not established in this record
- Canada
- Current authorization status not established in this record
Citations & Sources
- Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial
The New England Journal of Medicine · 2023
PMID 37366315 · DOI 10.1056/NEJMoa2301972
- Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA
Lancet · 2023
PMID 37385280 · DOI 10.1016/S0140-6736(23)01053-X
- TRIUMPH-1: Retatrutide in adults with obesity or overweight (NCT05929066).
Registry NCT05929066
- The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes).
Registry NCT06383390