NCT06525935CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered for 48 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
Carmot Therapeutics, Inc.63 sites in 1 country469 target enrollmentStarted: August 16, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Carmot Therapeutics, Inc.
- Enrollment
- 469
- Locations
- 63
- Primary Endpoint
- Percent Change in Body Weight from Baseline to Week 48
Study Overview
Brief Summary
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 with obesity or who are overweight with at least one weight-related comorbidity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female, 18 to 75 years of age
- •Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- •At least one self-reported unsuccessful effort to lose body weight
Exclusion Criteria
- •Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
- •Self-reported body weight change of >5 kg within 3 months before randomization
- •Any unbalanced/extreme diets within 3 months of the screening visit, or plan to be on such diets during the study
- •Current or recent participation in an organized weight reduction program
- •Current or recent use of any treatment that promotes weight loss or glucose metabolism
- •Current or recent use of treatment that may cause weight gain
- •Prior or planned surgical treatment for obesity
- •Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
- •History of chronic pancreatitis or acute pancreatitis within 6 months before screening
- •Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
- •History of major depressive disorder within 2 years of screening, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion)
- •Family or personal history of medullary thyroid carcinoma
- •Serum calcitonin ≥ 20 ng/L
- •Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method
Arms & Interventions
Arm 1: Placebo
Placebo Comparator
Placebo administered subcutaneously (SC) once weekly.
Intervention: Placebo (Drug)
Arm 6: Enicepatide Dose Level 5 (High)
Experimental
Enicepatide Dose Level 5 administered SC once weekly.
Intervention: Enicepatide (Drug)
Arm 2: Enicepatide Dose Level 1 (Low)
Experimental
Enicepatide Dose Level 1 administered SC once weekly.
Intervention: Enicepatide (Drug)
Arm 3: Enicepatide Dose Level 2
Experimental
Enicepatide Dose Level 2 administered SC once weekly.
Intervention: Enicepatide (Drug)
Arm 4: Enicepatide Dose Level 3
Experimental
Enicepatide Dose Level 3 administered SC once weekly.
Intervention: Enicepatide (Drug)
Arm 5: Enicepatide Dose Level 4
Experimental
Enicepatide Dose Level 4 administered SC once weekly.
Intervention: Enicepatide (Drug)
Outcomes
Primary Outcomes
Percent Change in Body Weight from Baseline to Week 48
Time Frame: Baseline to Week 48
Secondary Outcomes
- Percent Change in Body Weight from Baseline to Week 48 by Obesity Class(Baseline to Week 48)
- Change in Body Mass Index (BMI) from Baseline to Week 48(Baseline to Week 48)
- Change in Waist-to-Hip Ratio from Baseline to Week 48(Baseline to Week 48)
- Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48(Baseline and Week 48)
- Absolute Change in Body Weight (kg) from Baseline to Week 48(Baseline to Week 48)
- Change in Waist-to-Height Ratio from Baseline to Week 48(Baseline to Week 48)
- Change in Waist Circumference from Baseline to Week 48(Baseline to Week 48)
- Change in Hip Circumference from Baseline to Week 48(Baseline to Week 48)
- Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48(Baseline to Week 48)
- Change in Fasting C-peptide from Baseline to Week 48(Baseline to Week 48)
- Change in Fasting Plasma Glucose from Baseline to Week 48(Baseline to Week 48)
- Change in Fasting Insulin from Baseline to Week 48(Baseline to Week 48)
- Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c(Baseline and Week 48)
- Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48(Baseline to Week 48)
- Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48(Baseline to Week 48)
Investigators
Study Sites (63)
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