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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,250
Administered SC.
Administered SC.
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time frame: Baseline, Week 80
Change from Baseline in HbA1c (%)
Time frame: Baseline, Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5%
Time frame: Week 80
Percentage of Participants Who Achieve HbA1c < 5.7%
Time frame: Week 80
Percent Change from Baseline in Body Weight
Time frame: Week 80
Change from Baseline in Body Weight
Time frame: Baseline, Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 5%
Time frame: Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 10%
Time frame: Week 80
Percentage of Participants Who Achieve Weight Reduction of ≥ 15%
Time frame: Week 80
Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction
Time frame: Week 80
Percent Change from Baseline in Triglycerides
Time frame: Week 80
Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol
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University of Alabama - Department of Nutrition Sciences
Birmingham, Alabama, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
Long Beach Research Institute
Long Beach, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
New Age Medical Research Corporation
Miami, Florida, United States
South Broward Research
Miramar, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
...and 67 more locations
Time frame: Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 80