Diabetes Mellitus, Type 2
Conditions
Keywords
Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Incretins
Brief summary
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.
Interventions
DRUGRetatrutide
Administered SC.
DRUGSemaglutide
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have Type 2 Diabetes (T2D) * Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) * Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2)
Exclusion criteria
* Have Type 1 Diabetes (T1D) * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification IV congestive heart failure * Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * Have a known clinically significant gastric emptying abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) (%) | Baseline, Week 80 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in HbA1c (%) | Baseline, Week 80 |
| Percentage of Participants Who Achieve HbA1c ≤ 6.5% | Week 80 |
| Percentage of Participants Who Achieve HbA1c < 5.7% | Week 80 |
| Percent Change from Baseline in Body Weight | Week 80 |
| Change from Baseline in Body Weight | Baseline, Week 80 |
| Percentage of Participants Who Achieve Weight Reduction of ≥ 5% | Week 80 |
| Percentage of Participants Who Achieve Weight Reduction of ≥ 10% | Week 80 |
| Percentage of Participants Who Achieve Weight Reduction of ≥ 15% | Week 80 |
| Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction | Week 80 |
| Percent Change from Baseline in Triglycerides | Week 80 |
| Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol | Week 80 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 80 |
Countries
Argentina, Canada, Mexico, Puerto Rico, United States
Contacts
STUDY_DIRECTORCall 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
Outcome results
None listed