DelfaGLP-1 Atlas

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Active not recruitingPhase 3

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

745

Recruiting sites

—

Enrollment

10,000

estimated

Study population

Cardiovascular disease, Chronic kidney disease, Obesity / overweight

Key I/E criteria

•BMI ≥27•Established ASCVD/CKD•eGFR ≤45•UACR ≥30

Primary endpoints

•4-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke, Heart-failure hospitalization)•Custom renal composite (End-stage renal disease, eGFR, change, Cardiovascular death, Renal death)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06383390
Org study ID18584
Secondary ID2023-508630-34-00EU CTR Number
Secondary IDJ1I-MC-GZBOEli Lilly and Company

Timeline

Milestones

Study first posted2024-04-25actual
Study start2024-04-30actual
Last update posted2026-04-20actual
Primary completion2029-02estimated (month precision)
Study completion2029-02estimated (month precision)

Assets

Investigational agents

Retatrutide

Study populations

Who this study enrolls

Cardiovascular diseaseChronic kidney diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age45 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower
•Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following:
–Coronary artery disease
–Cerebrovascular disease
–Peripheral arterial disease
–Chronic kidney disease defined as:
–eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR >30 milligram/gram (mg/g) (0.030 mg/mg)
–eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g (0.100 mg/mg), or
–eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab)
•A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)

Exclusion criteria

Diabetes related:

•Participants have Type 1 Diabetes or any history of diabetic ketoacidosis

CV related:

•Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization:
–Myocardial infarction
–Acute coronary syndrome
–Stroke, or
–Coronary, peripheral, or carotid artery arterial revascularization procedure.
•Have acute decompensated heart failure requiring hospitalization.
•Have New York Heart Association (NYHA) Classification Class IV heart failure at screening

Kidney related:

•Participants have an eGFR <20 mL/min/1.73 m^2 at screening
•Have UACR >5000 mg/g (5.000 mg/mg) at screening
•Have received any form of dialysis ≤ 90 days from the date of randomization
•Have either undergone a kidney transplant or have a transplant procedure scheduled

Other medical conditions:

•Participants have had or plan to have a surgical treatment for obesity,
•Have a history of chronic or acute pancreatitis
•Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
•Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
4
Renal / kidney
3

Cardiovascular outcomes

4 endpoints
Primary/protocol endpoint

Time to First Occurrence of Composite Endpoints

Time frame:Randomization up to Study Completion (Approximate 248 Weeks)

4-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Heart-failure hospitalization, Urgent heart-failure visit

Secondary/protocol endpoint

Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3)

Time frame:Randomization up to Study Completion (Approximate 248 Weeks)

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Secondary/protocol endpoint

Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF

Time frame:Randomization up to Study Completion (Approximate 248 Weeks)

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Heart-failure hospitalization, Urgent heart-failure visit

Secondary/protocol endpoint

Time to Occurrence of All-Cause Death

Time frame:Randomization up to Study Completion (Approximate 248 Weeks)

All-cause death

time to event, event

SNOMED 419620001

Renal / kidney

3 endpoints
Primary/protocol endpoint

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

Time frame:Randomization up to Study Completion (Approximate 248 Weeks)

Custom renal composite

time to event, event

componentsEnd-stage renal disease, eGFR, change, Cardiovascular death, Renal death

Secondary/protocol endpoint

Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death

Time frame:Randomization up to Study Completion (Approximate 248 Weeks)

Custom renal composite

time to event, event

componentseGFR, change, End-stage renal disease, Renal death

Secondary/protocol endpoint

Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline

Time frame:Randomization up to Study Completion (Approximate 248 Weeks)

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.