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Brief Summary:
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overweight and Obesity | Drug: Retatrutide Drug: Placebo | Phase 3 |
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| Study Type : | Interventional (Clinical Trial) |
| EstimatedEnrollment : | 10000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | 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 the Decline in Kidney Function in Participants With Body Mass Index ≥27 kg/m^2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease. |
| Estimated Study Start Date : | May 2024 |
| Estimated Primary Completion Date : | February 2029 |
| Estimated Study Completion Date : | February 2029 |
Resource links provided by the National Library of Medicine 
MedlinePlus related topics: KidneyDiseases
U.S. FDA Resources
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| Arm | Intervention/treatment |
|---|---|
| Experimental: Retatrutide Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose. | Drug: Retatrutide Administered SC Other Name: LY3437943 |
| Placebo Comparator: Placebo Participants will receive matching placebo administered SC. | Drug: Placebo Administered SC |
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Primary Outcome Measures :
- Time to First Occurrence of Composite Endpoints [TimeFrame: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 [TimeFrame: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 a second measurement at the earliest 4 weeks after the initial measurement at the central laboratory, initiation of dialysis for at least 30 days, receiving a kidney transplant.
Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure 1 month after the initial result.
Secondary Outcome Measures :
- Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3) [TimeFrame:Randomization up to Study Completion (Approximate 248 Weeks)]
MACE-3 includes CV death, nonfatal MI, and nonfatal stroke.
- Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF [TimeFrame:Randomization up to Study Completion (Approximate 248 Weeks)]
Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF.
- Time to Occurrence of All-Cause Death [TimeFrame:Randomization up to Study Completion (Approximate 248 Weeks)]
Time to all-cause death.
- Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death [TimeFrame:Randomization up to Study Completion (Approximate 248 Weeks)]
- Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline [TimeFrame:Randomization up to Study Completion (Approximate 248 Weeks)]
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)
- Participants may be with or without type 2 diabetes (T2D) unless 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)
- eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g, or
- eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (eGFR is calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin c equation as determined by central lab)
Exclusion Criteria:
Diabetes related:
- Participants have Type 1 Diabetes or 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 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
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06383390
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | ClinicalTrials.gov@lilly.com |
Locations
Show 349 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
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| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT06383390 |
| Other Study ID Numbers: | 18584 J1I-MC-GZBO ( Other Identifier: Eli Lilly and Company ) 2023-508630-34-00 ( Other Identifier: EU CTR Number ) |
| First Posted: | April 25, 2024 Key Record Dates |
| Last Update Posted: | April 25, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
| Supporting Materials: | Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting. |
| Access Criteria: | research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
| URL: | http://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
Keywords provided by Eli Lilly and Company:
| Cardiovascular Disease Kidney Disease Overweight Obesity Major Adverse Cardiovascular Events (MACE) | Atherosclerotic Cardiovascular Disease (ASCVD) Renal Outcomes Cardiovascular Risk Reduction Kidney Disease Progression Cardiometabolic Risk Factors |
Additional relevant MeSH terms:
| Cardiovascular Diseases Obesity Overweight | Overnutrition Nutrition Disorders Body Weight |
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