The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
320
Administered SC
Administered SC
Nephrology Consultants
Huntsville, Alabama, United States
Clinical Research Institute of Arizona (CRI) - Sun City West
Sun City West, Arizona, United States
Kidney & Hypertension Center - Apple Valley
Apple Valley, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
Change from Baseline in Hemoglobin A1c (HbA1c) (%)
Time frame: Baseline, Week 52
Percentage of Participants Achieving HbA1c <7.0%
Time frame: Week 52
Percentage of Participants Achieving HbA1c ≤6.5%
Time frame: Week 52
Change from Baseline in Fasting Serum Glucose
Time frame: Baseline, Week 52
Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL
Measured during the CGM session that occurs during 30 days prior to Week 52
Time frame: Week 52
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 52
Change from Baseline in Body Weight
Time frame: Baseline, Week 52
Percentage of Participants Achieving Weight Reduction of ≥5%
Time frame: Week 52
Percentage of Participants Achieving Weight Reduction of ≥10%
Time frame: Week 52
Percentage of Participants Achieving Weight Reduction of ≥15%
Time frame: Week 52
Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction
Time frame: Week 52
Percent Change from Baseline in Non-HDL Cholesterol
Time frame: Baseline, Week 52
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 52
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 52
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EndoTrials Center for Clinical Research
La Mesa, California, United States
UCLA South Bay Endocrinology
Torrance, California, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
Encore Medical Research - Weston
Weston, Florida, United States
Orita Clinical Research
Decatur, Georgia, United States
...and 66 more locations