This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
469
Percent Change in Body Weight from Baseline to Week 48
Time frame: Baseline to Week 48
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Time frame: Baseline and Week 48
Absolute Change in Body Weight (kg) from Baseline to Week 48
Time frame: Baseline to Week 48
Percent Change in Body Weight from Baseline to Week 48 by Obesity Class
Time frame: Baseline to Week 48
Change in Body Mass Index (BMI) from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Waist Circumference from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Hip Circumference from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Waist-to-Hip Ratio from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Waist-to-Height Ratio from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Fasting Plasma Glucose from Baseline to Week 48
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Central Alabama Research
Homewood, Alabama, United States
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
Mesa, Arizona, United States
Amicis Research Center - Anaheim
Anaheim, California, United States
Ark Clinical-Fountain Valley
Fountain Valley, California, United States
Ark Clinical Research - Long Beach
Long Beach, California, United States
Velocity Clinical Research - Los Angeles
Los Angeles, California, United States
Infinity Clinical Research
Norco, California, United States
Amicis Research Center
Northridge, California, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, United States
...and 24 more locations
Time frame: Baseline to Week 48
Change in Fasting Insulin from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Fasting C-peptide from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48
Time frame: Baseline to Week 48
Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48
Time frame: Baseline to Week 48
Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c
Time frame: Baseline and Week 48