This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
447
Placebo will be volume-matched and administered subcutaneously (SC) once weekly.
Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.
Percent Change in Body Weight from Baseline to Week 36
Time frame: Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36
Time frame: Baseline to Week 36
Percent Change in Body Weight from Baseline to Week 48
Time frame: Baseline to Week 48
Change in HbA1c from Baseline to Week 48
Time frame: Baseline to Week 48
Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48
Time frame: Weeks 36 and 48
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36
Time frame: Baseline and Week 36
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Time frame: Baseline and Week 48
Percent Change in Body Weight from Baseline to Week 28
Time frame: Baseline and Week 28
Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48
Time frame: Baseline to Weeks 36 and 48
Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Time frame: Baseline to Weeks 16, 28, 36, and 48
Change in HbA1c from Baseline to Weeks 16 and 28
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Time frame: Baseline to Weeks 16 and 28
Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Time frame: Baseline to Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48
Time frame: Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48
Time frame: Weeks 16, 28, 36, and 48
Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48
Time frame: Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48
Time frame: Baseline, Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48
Time frame: Baseline, Weeks 16, 28, 36, and 48
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Waist Circumference from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Hip Circumference from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48
Time frame: Baseline, Weeks 36 and 48
Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48
Time frame: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48
Time frame: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48
Time frame: Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48
Time frame: Baseline to Weeks 16, 28, 36, and 48