Evidence memo / Metabolic & weight

Retatrutide

Also: LY3437943 · triple receptor agonist

An investigational triple receptor agonist with strong phase 2 obesity and metabolic signals plus a large Phase 3 program. It is not approved by FDA, and late-stage outcomes, durability, tolerability, and product-identity boundaries remain the Watchlist center of gravity.

Controlled human dataPhase 2 / Phase 3InvestigationalSafety / regulatory watch

The verdict

Our read at a glance.

Whether Lilly's investigational LY3437943/retatrutide can convert strong early obesity, type 2 diabetes, and MASLD signals into durable clinical outcomes with an acceptable tolerability and safety boundary.

The signal
Published direct evidence is strongest for phase 1/2 and phase 2a signals: obesity, type 2 diabetes, liver fat/MASLD, eating behavior, lipids, kidney parameters, and body composition. Many Phase 3 and outcomes records are active or completed, but full peer-reviewed Phase 3 and outcomes evidence remains the boundary.
The unknown
Whether Phase 3 publications and regulatory review confirm durable benefit-risk, discontinuation and maintenance patterns, lean-mass implications, cardiovascular and renal outcomes, MASLD/MASH outcomes, gallbladder and pancreatitis risk, and tolerability at scale.
Our read
High signal, still provisional. Retatrutide belongs on the Watch Closely list because the early signal is unusually strong, but the clinical boundary is still being written by Phase 3 results, outcomes studies, and regulators.

The explainer

Watch the 31:01 explainer.

31K views · May 2026

The mechanism

How it works.

Retatrutide is an investigational peptide drug that activates three metabolic hormone receptors at once: GLP-1, GIP, and glucagon. The GLP-1 and GIP arms act on the brain and pancreas to blunt appetite, slow stomach emptying, and increase glucose-dependent insulin release, while the added glucagon-receptor activity raises energy expenditure and pushes the liver to burn fat. In phase 2 trials this combination drove large body-weight reductions, but the long-term benefit and risk balance has not yet been confirmed in completed phase 3 outcome studies.

Safety & regulatory boundary

The consequential part.

Retatrutide is investigational and not approved by FDA as of 2026-05-16. Lilly's studied product is not interchangeable with compounded, research-use, export-only, non-Lilly, or internet-market products using the same name. GI tolerability and heart-rate signal are direct safety-watch areas.

What's next

What we're watching.

Full Phase 3 publications, regulatory filings, posted registry results, adverse-event patterns, discontinuation and maintenance data, lean-mass analyses, MASLD/MASH data, and cardiovascular, kidney, sleep-apnea, osteoarthritis, and pain outcomes.

Context

Why this is discussed.

Retatrutide sits near the center of obesity-drug attention because early human data suggested large body-weight effects and because TRIUMPH, TRANSCEND, and related outcomes programs are testing broader cardiometabolic, kidney, pain, sleep-apnea, and liver questions.

The evidence base

66 cited references.

Regulatory & labels6

FDA concerns with unapproved GLP-1 drugs used for weight loss

U.S. Food and Drug Administration · Current FDA page

FDA GSRS: Retatrutide, UNII NOP2Y096GV

FDA Global Substance Registration System · Current database page

EMA pediatric investigation plan decision for retatrutide

European Medicines Agency · 2024-09-13

FDA warning letter context for offered retatrutide products

U.S. Food and Drug Administration · 2026-03-31

Registered trials21

ClinicalTrials.gov: LY3437943 early safety study

ClinicalTrials.gov · NCT03841630; completed

ClinicalTrials.gov: Retatrutide phase 2 type 2 diabetes study

ClinicalTrials.gov · NCT04867785; results posted 2023

ClinicalTrials.gov: Retatrutide phase 2 obesity or overweight study

ClinicalTrials.gov · NCT04881760; results posted 2023

ClinicalTrials.gov: Retatrutide TRIUMPH-3

ClinicalTrials.gov · NCT05882045; active not recruiting

ClinicalTrials.gov: Retatrutide TRIUMPH-1

ClinicalTrials.gov · NCT05929066; active not recruiting

ClinicalTrials.gov: Retatrutide TRIUMPH-2

ClinicalTrials.gov · NCT05929079; active not recruiting

ClinicalTrials.gov: Retatrutide TRIUMPH-4

ClinicalTrials.gov · NCT05931367; completed

ClinicalTrials.gov: Retatrutide renal-function study

ClinicalTrials.gov · NCT05936151; completed

ClinicalTrials.gov: Retatrutide TRIUMPH-Outcomes

ClinicalTrials.gov · NCT06383390; active not recruiting

ClinicalTrials.gov: Retatrutide TRANSCEND-T2D-2

ClinicalTrials.gov · NCT06260722; active not recruiting

ClinicalTrials.gov: Retatrutide TRANSCEND-T2D-3

ClinicalTrials.gov · NCT06297603; active not recruiting

ClinicalTrials.gov: Retatrutide TRANSCEND-T2D-1

ClinicalTrials.gov · NCT06354660; completed

ClinicalTrials.gov: Retatrutide TRIUMPH-5

ClinicalTrials.gov · NCT06662383; active not recruiting

ClinicalTrials.gov: Retatrutide TRIUMPH-6

ClinicalTrials.gov · NCT06859268; active not recruiting

ClinicalTrials.gov: Retatrutide hypoglycemia-response study

ClinicalTrials.gov · NCT06982846; active not recruiting

ClinicalTrials.gov: Retatrutide TRIUMPH-7

ClinicalTrials.gov · NCT07035093; recruiting

ClinicalTrials.gov: SYNERGY-Outcomes MASLD master study

ClinicalTrials.gov · NCT07165028; recruiting

ClinicalTrials.gov: Retatrutide TRIUMPH-9 study record

ClinicalTrials.gov · NCT07357415; recruiting

Indexed literature (PubMed)34

Sponsor & other sources5

WHO proposed INN list 128: retatrutide

World Health Organization · 2022

What to know about retatrutide

Eli Lilly and Company · Current sponsor page

Retatrutide TRANSCEND-T2D-1 sponsor topline release

Eli Lilly and Company · 2026-03-19

Retatrutide TRIUMPH-4 sponsor topline release

Eli Lilly and Company · 2025-12-11

Lilly Q1 2026 results: retatrutide pipeline status

Eli Lilly and Company · 2026-04-30

Keep reading

Related published memos.