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> Record changed: 2026-11-04

# A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

NCT05882045

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

Participants

1,946

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

Lead sponsor

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

Start date

2023-05-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

Number of sites

169

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Title and summary

**Summary**

The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Acronym**

TRIUMPH-3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Short title**

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Official title**

A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Dates

**Completion date**

2026-05-14

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**First posted**

2023-05-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Registry last updated**

2026-07-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Primary completion date**

2026-04-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Start date**

2023-05-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Size and sites

**Actual participants**

1,946

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Participants**

1,946

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Protocol amendments**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Number of sites**

169

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Lead sponsor**

Eli Lilly and Company

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Identifiers

**Registry ID**

NCT05882045

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**ClinicalTrials.gov ID**

NCT05882045

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Outcomes

### Primary outcomes

1. Percent Change from Baseline in Body Weight  
Timeframe: Baseline, Week 80

### Secondary outcomes

1. Change from Baseline in Body Mass Index (BMI)  
Timeframe: Baseline, Week 80
2. Change from Baseline in Waist Circumference  
Timeframe: Baseline, Week 80
3. Percent Change from Baseline in Total Cholesterol  
Timeframe: Baseline, Week 80
4. Percent Change from Baseline in Triglycerides  
Timeframe: Baseline, Week 80
5. Change from Baseline in Systolic Blood Pressure (SBP)  
Timeframe: Baseline, Week 80
6. Change from Baseline in Diastolic Blood Pressure (DBP)  
Timeframe: Baseline, Week 80
7. Change from Baseline in Hemoglobin A1c (HbA1c)  
Timeframe: Baseline, Week 80
8. Percent Change from Baseline in Fasting Insulin  
Timeframe: Baseline, Week 80
9. Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score  
Timeframe: Baseline, Week 80
10. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)  
Timeframe: Baseline to Week 80  
AUC is presented as a single average measure of AUC across the study duration.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

- Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
- Have established cardiovascular (CV) disease with at least 1 of the following:

  - prior myocardial infarction
  - prior ischemic or hemorrhagic stroke, or
  - symptomatic peripheral arterial disease
- Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

### Exclusion criteria

- Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- Have a prior or planned surgical treatment of obesity.
- Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
- Have Type 1 diabetes.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Sites

- Central Phoenix Medical ClinicPhoenix, United States
- Valley Clinical Trials, Inc.Covina, United States
- Neuro-Pain Medical CenterFresno, United States
- Valley ResearchFresno, United States
- Collaborative Neuroscience Research, LLCLos Alamitos, United States
- Velocity Clinical Research, WestlakeLos Angeles, United States
- Valley Clinical Trials, Inc.Northridge, United States
- Velocity Clinical Research, Panorama CityVan Nuys, United States
- Chase Medical Research, LLCWaterbury, United States
- Indago Research & Health Center, IncHialeah, United States
- Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonville, United States
- Clinical Neuroscience Solutions, Inc.Orlando, United States
- Charter Research - Winter ParkOrlando, United States
- Progressive Medical ResearchPort Orange, United States
- Pacific Diabetes & Endocrine CenterHonolulu, United States
- Elite Clinical TrialsBlackfoot, United States
- Humphreys Diabetes CenterBoise, United States
- Northwestern UniversityChicago, United States
- Great Lakes Clinical Trials - GurneeGurnee, United States
- Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research CooperativeSpringfield, United States
- Brengle Family MedicineIndianapolis, United States
- Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United States
- Cotton O'Neil Diabetes & EndocrinologyTopeka, United States
- MedVadis Research CorporationWaltham, United States
- StudyMetrix ResearchCity of Saint Peters, United States

And 144 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## References

- Related resource (trials.lilly.com)  
Source: [trials.lilly.com](https://trials.lilly.com/en-US/trial/405675)

### Other registry identifiers (3)

- 2023
- 2023-503659-88-00
- J1I-MC-GZBM

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05882045)

## Related records

### Drugs (1)

- [Retatrutide](https://trialight.com/data/asset/retatrutide-1c18d390-804a-469b-95a1-d654ddcca41e.md)

### Lead sponsors (1)

- [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md)

### Conditions (2)

- [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md)
- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition

### Targets (3)

- [GCGR](https://trialight.com/data/target/gcgr-418174f7-cf4a-56a4-9273-4cd98d0bc903.md)
- [GIPR](https://trialight.com/data/target/gipr-5b65dd73-9875-5aca-be7a-5469a7290f0c.md)
- [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md)

---

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