A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
- 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.
- Short title
- A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-12-08
- First posted
- 2024-07-29
- Registry last updated
- 2026-10-05
- Primary completion date
- 2025-12-08
- Start date
- 2024-08-16
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Carmot Therapeutics, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06525935
- ClinicalTrials.gov ID
- NCT06525935
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percent Change in Body Weight from Baseline to Week 48
Timeframe: Baseline to Week 48
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Timeframe: Baseline and Week 48
Absolute Change in Body Weight (kg) from Baseline to Week 48
Timeframe: Baseline to Week 48
Percent Change in Body Weight from Baseline to Week 48 by Obesity Class
Timeframe: Baseline to Week 48
Change in Body Mass Index (BMI) from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Waist Circumference from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Hip Circumference from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Waist-to-Hip Ratio from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Waist-to-Height Ratio from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Fasting Plasma Glucose from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Fasting Insulin from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Fasting C-peptide from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48
Timeframe: Baseline to Week 48
Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48
Timeframe: Baseline to Week 48
Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c
Timeframe: Baseline and Week 48
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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
- 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
- Alabama Clinical Therapeutics, LLCBirmingham, United States
- Central Alabama ResearchHomewood, United States
- The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver HealthMesa, United States
- Amicis Research Center - AnaheimAnaheim, United States
- Ark Clinical-Fountain ValleyFountain Valley, United States
- Ark Clinical Research - Long BeachLong Beach, United States
- Velocity Clinical Research - Los AngelesLos Angeles, United States
- Infinity Clinical ResearchNorco, United States
- Amicis Research CenterNorthridge, United States
- Prospective Research Innovations Inc.Rancho Cucamonga, United States
- Orange County Research CenterTustin, United States
- Amicis Research Center - West HillsWest Hills, United States
- Tampa Bay Medical Research, Inc.Clearwater, United States
- Progressive Medical ResearchPort Orange, United States
- Louisville Metabolic and Atherosclerosis Research Center (L-MARC)Louisville, United States
- The Center for Pharmaceutical ResearchKansas City, United States
- Mercury Street Medical GroupButte, United States
- Neurobehavioral Research, Inc. (NBR)Cedarhurst, United States
- Lucas Research, IncMorehead City, United States
- Velocity Clinical Research - CincinnatiCincinnati, United States
- Velocity Clinical Research, ProvidenceEast Greenwich, United States
- Tribe Clinical ResearchGreenville, United States
- Alliance for Multispecialty Research, LLCKnoxville, United States
- Clinical Research Associates, Inc.Nashville, United States
- Texas Diabetes & Endocrinology, P.A.Austin, United States
And 9 more, listed on the interactive page.
Other registry identifiers
- XC45526
Related records
Drugs (1)
Collaborators (1)
Lead sponsors (1)
Conditions (1)
- Obesity disorder Primary condition