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Retatrutide

Phase 3

Type 2 Diabetes | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jul 20, 2026

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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,320
FDA Designations
No designations recorded
Clinical trial landscape

Retatrutide · 17 trials · 18 indications

Phase 3 13Phase 2 1Phase 1 3
NCT07357415A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or OverweightObesity
ACTIVE NOT_RECRUITING600 Analytics
NCT07232719A Study of Retatrutide (LY3437943) in Participants With Obesity or OverweightObesity
ACTIVE NOT_RECRUITING250 Analytics
NCT07035093A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back PainObesity
RECRUITING586 Analytics
NCT06859268A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With ObesityObesity
ACTIVE NOT_RECRUITING643 Analytics
NCT06662383A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have ObesityObesity
ACTIVE NOT_RECRUITING800 Analytics
NCT06383390The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)Atherosclerotic Cardiovascular Disease (ASCVD)
ACTIVE NOT_RECRUITING10,000 Analytics
NCT06354660Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)Diabetes Type 2
COMPLETED537 Analytics
NCT06297603Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)Type 2 Diabetes
ACTIVE NOT_RECRUITING320 Analytics
NCT06260722Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)Diabetes Mellitus, Type 2
ACTIVE NOT_RECRUITING1,250 Analytics
NCT05931367A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the KneeObesity
COMPLETED445 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight
Obesity
NCT07357415600
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PHASE3ACTIVE NOT_RECRUITING
A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight
Obesity
NCT07232719250
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PHASE3RECRUITING
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
Obesity
NCT07035093586
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PHASE3ACTIVE NOT_RECRUITING
A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity
Obesity
NCT06859268643
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PHASE3ACTIVE NOT_RECRUITING
A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity
Obesity
NCT06662383800
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PHASE3ACTIVE NOT_RECRUITING
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Atherosclerotic Cardiovascular Disease (ASCVD)
NCT0638339010,000
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PHASE3COMPLETED
Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
Diabetes Type 2
NCT06354660537
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PHASE3ACTIVE NOT_RECRUITING
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
Type 2 Diabetes
NCT06297603320
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PHASE3ACTIVE NOT_RECRUITING
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Diabetes Mellitus, Type 2
NCT062607221,250
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PHASE3COMPLETED
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
Obesity
NCT05931367445
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Study Endpoints
Primary Endpoints
Percent Change from Baseline in Body Weight
Baseline, Week 104
Change from Baseline in Pain Intensity Per Numeric Rating Scale
Baseline, up to 72 weeks
Time to First Occurrence of Composite Endpoints
Randomization up to Study Completion (Approximate 248 Weeks)

A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF).

Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death
Randomization up to Study Completion (Approximate 248 Weeks)

ESKD is defined as the following individual components: persistent eGFR \<15 mL/min/1.73 m\^2 confirmed by 2 measurements at least 4 weeks apart at the central laboratory, initiation of dialysis for at least 28 days, receiving a kidney transplant. Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure at least 4 weeks after the first result.

Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Baseline, Week 40
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Baseline, Week 68
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Baseline, Week 80
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset
Baseline, Week 80
Percent Change from Baseline in Body Weight to
Baseline, Week 104
Change from Baseline in Glomerular Filtration Rate (mGFR)
Baseline, Week 24

The GFR in milliliter/minute per1.73 square meter (mL/min/1.73 m²) using iohexol clearance (mGFR-measured glomerular filtration rate)

Time-to-Event of Recovery of Plasma Glucose (PG) Concentration from 48 Milligram per Deciliter (48 mg/dL) to 70 mg/dL (tPG_nadir-70 mg/dL)
Within 60 minutes after nadir

Time-to-event of recovery of PG concentration from 48 mg/dL to 70 mg/dL.

Change from Baseline in Total Clamp Disposition Index (cDI) for Comparison of Retatrutide With Placebo
Baseline, Week 28

Change from baseline in total cDI for comparison of retatrutide with placebo

Pharmacokinetics (PK): Area Under Concentration From Time Zero to Infinity (AUC[0-∞]) of Metoprolol
Day 1 to Day 3

PK: AUC (0-∞) of Metoprolol

Pharmacokinetics (PK): AUC (0-∞) of Metoprolol with Retatrutide
Day 9 to Day 11

PK: AUC (0-∞) of Metoprolol with Retatrutide

PK: Maximum Concentration (Cmax) of Metoprolol
Day 1 to Day 3

PK: Cmax of Metoprolol

PK: Cmax of Metoprolol with Retatrutide
Day 9 to Day 11
Secondary Endpoints
Change from Baseline in Waist Circumference
Baseline, Week 104
Percent Change from Baseline in Triglycerides
Baseline, Week 104
Change from Baseline in Systolic Blood Pressure
Baseline, Week 104
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Retatrutide Dose Escalation 1EXPERIMENTALParticipants will receive retatrutide subcutaneously (SC)
Retatrutide Dose Escalation 2EXPERIMENTALParticipants will receive retatrutide SC
Retatrutide Dose Escalation 3EXPERIMENTALParticipants will receive retatrutide SC
Retatrutide Dose 1EXPERIMENTALParticipants will receive retatrutide subcutaneously (SC)
Retatrutide Dose 2EXPERIMENTALParticipants will receive retatrutide SC
PlaceboPLACEBO_COMPARATORParticipants will receive placebo SC
RetatrutideEXPERIMENTALParticipants will receive Retatrutide subcutaneously (SC)
Retatrutide Dose 1 to Retatrutide Dose 2EXPERIMENTALParticipants will receive retatrutide dose 1 administered SC for 80 weeks, then retatrutide dose 2 administered SC for an additional 36 weeks
Retatrutide Dose 1 to PlaceboPLACEBO_COMPARATORParticipants will receive retatrutide dose 1 administered SC for 80 weeks, then placebo administered SC for an additional 36 weeks
TirzepatideACTIVE_COMPARATORParticipants will receive tirzepatide administered SC
Retatrutide Dose Level 1EXPERIMENTALParticipants will receive retatrutide administered subcutaneously (SC).
Retatrutide Dose Level 2EXPERIMENTALParticipants will receive retatrutide administered SC.
Retatrutide Dose Level 3EXPERIMENTALParticipants will receive retatrutide administered SC.
Retatrutide Dose 3EXPERIMENTALParticipants will receive retatrutide administered SC.
SemaglutideACTIVE_COMPARATORParticipants will receive semaglutide administered SC.
Retatrutide Extension PeriodEXPERIMENTALParticipants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.
Interventions
NameTypeDescription
RetatrutideDRUGAdministered SC
PlaceboDRUGAdministered SC
TirzepatideDRUGAdministered SC
SemaglutideDRUGAdministered SC.
MetoprololDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Have a Body Mass Index (BMI) at screening * ≥ 30 kilogram per square meter (kg/m2) OR * ≥ 27 kg/m2 with presence of at least one of the following weight-related conditions at screening: high blood pressure, abnormal levels of lipid, obstructive sleep apnea, heart disease ...

Countries:United StatesArgentinaCanadaUnited KingdomPolandGermanyPuerto RicoAustraliaAustriaBelgiumBrazilCzechiaDenmarkFranceGreeceHungaryIndiaIsraelItalyMexicoNetherlandsNew ZealandRomaniaSlovakiaSpainTurkey (Türkiye)UkraineSingapore
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Competitive Landscape -Type 2 Diabetes 148 trials

Top 20 of 33 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY17PHASE3Retatrutide
Amgen Inc.AMGN4PHASE3Maridebart cafraglutide
Novo Nordisk A/S Sponsored ADR Class BNVO21PHASE3semaglutide
Pfizer Inc.PFE1PHASE3PF-08653944
Oramed Pharmaceuticals IncorporatedORMP1PHASE3ORMD-0801
ProKidney Corp. Class APROK1PHASE3Renal Autologous Cell Therapy
NewAmsterdam Pharma Company N.V.NAMS1PHASE3obicetrapib, ezetimibe daily
AstraZeneca PLCAZN3PHASE2AZD6234
Alnylam Pharmaceuticals, IncALNY2PHASE2ALN-4324
MediciNova, Inc.MNOV1PHASE2MN-001
MannKind CorporationMNKD1PHASE2Technosphere Insulin
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE1ARO-ALK7
Merck & Co., Inc.MRK1PHASE1MK-1403, additive coformulation
Abbott LaboratoriesABT7N/AUndisclosed
Insulet CorporationPODD5 - Undisclosed
Milestone Pharmaceuticals, Inc.MIST2PHASE2CX11
Biomea Fusion IncBMEA2PHASE2icovamenib
Unity Health TorontoUBX1PHASE3Undisclosed
DexCom, Inc.DXCM6N/AUndisclosed
Design Therapeutics, Inc.DSGN1PHASE2Farxiga, Onglyza, Metformin Mix Treat type 2 diabetes, China Import
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Recent Changes (Last 90 Days)
LOWJul 20, 2026NCT06297603lastUpdatePostDate: changed
LOWJul 20, 2026NCT06383390lastUpdatePostDate: changed
LOWJul 20, 2026NCT06662383primaryCompletionDate: changed
LOWJul 20, 2026NCT06297603lastUpdatePostDate: changed
LOWJul 20, 2026NCT06383390lastUpdatePostDate: changed
LOWJul 20, 2026NCT06662383primaryCompletionDate: changed
MEDIUMJul 19, 2026NCT06982846TRIAL_REMOVED: changed
MEDIUMJul 19, 2026NCT06982846TRIAL_REMOVED: changed
MEDIUMJul 19, 2026NCT06982846TRIAL_REMOVED: changed
MEDIUMJul 19, 2026NCT06982846TRIAL_REMOVED: changed
MEDIUMJul 17, 2026NCT06982859Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 17, 2026NCT06982859Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 17, 2026NCT06982859Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 4, 2026NCT05929066TRIAL_REMOVED: changed
MEDIUMJul 4, 2026NCT05929066TRIAL_REMOVED: changed
MEDIUMJul 4, 2026NCT05929066TRIAL_REMOVED: changed
LOWJun 18, 2026NCT06383390lastUpdatePostDate: changed
HIGHJun 18, 2026NCT06982846Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWJun 18, 2026NCT06383390lastUpdatePostDate: changed
HIGHJun 18, 2026NCT06982846Status: ACTIVE_NOT_RECRUITING → COMPLETED