Current Retatrutide Clinical Status: Retatrutide (LY3437943) is an investigational triple hormone receptor agonist undergoing Phase 3 clinical trials (the TRIUMPH program). Published Phase 2 trials demonstrated dose-dependent effects on metabolic parameters, HbA1c, and liver fat, but it remains an unapproved investigational molecule.
When reviewing scientific and pharmaceutical data on retatrutide, researchers must maintain a strict distinction between three distinct tiers of information:
The landmark clinical investigations of retatrutide have been published across premier peer-reviewed biomedical journals:
48-week, randomized, double-blind Phase 2 trial evaluating 338 adults across 1mg, 4mg, 8mg, and 12mg weekly subcutaneous cohorts. Registered under ClinicalTrials.gov: NCT04881760.
Evaluated glycemic control and HbA1c reductions in patients with type 2 diabetes, demonstrating robust glucose homeostasis alongside insulin sensitization.
Assessed hepatic steatosis via MRI-PDFF, documenting normalisation of liver fat (<5% fat fraction) in over 85% of subjects receiving 8mg or 12mg at 24 weeks.
Preclinical pharmacology detailing triple receptor agonist potency ratios, EC50 binding affinity profiles, and molecular design of LY3437943.
To establish multi-year safety, cardiovascular outcomes, and regulatory endpoints, Eli Lilly initiated the multi-center Phase 3 TRIUMPH registration program registered on ClinicalTrials.gov:
| Trial Name | ClinicalTrials.gov Identifier | Target Population | Primary Endpoints |
|---|---|---|---|
| TRIUMPH-1 | NCT05882045 ↗ | Obesity / Overweight without Diabetes | Percentage change in body weight at Week 72 |
| TRIUMPH-2 | NCT05929066 ↗ | Type 2 Diabetes & Overweight | Change in HbA1c and weight reduction at Week 80 |
| TRIUMPH-3 | NCT05931302 ↗ | Severe Obesity with Established CVD | Cardiovascular risk markers & weight trajectory |
| TRIUMPH-4 | NCT06176469 ↗ | Knee Osteoarthritis & Obesity | WOMAC pain score change & weight reduction |
Crucial Fact: Retatrutide is not approved by the US FDA, Australian TGA, European EMA, or any other international drug authority. It is an unapproved, investigational drug currently undergoing Phase 3 safety auditing.
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