A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
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
2 other identifiers
interventional
469
1 country
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Aug 2024
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedStudy Start
First participant enrolled
August 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2025
CompletedApril 17, 2026
April 1, 2026
1.3 years
July 23, 2024
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change in Body Weight from Baseline to Week 48
Baseline to Week 48
Secondary Outcomes (15)
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
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 Circumference from Baseline to Week 48
Baseline to Week 48
- +10 more secondary outcomes
Study Arms (6)
Arm 1: Placebo
PLACEBO COMPARATORPlacebo administered subcutaneously (SC) once weekly.
Arm 2: Enicepatide Dose Level 1 (Low)
EXPERIMENTALEnicepatide Dose Level 1 administered SC once weekly.
Arm 3: Enicepatide Dose Level 2
EXPERIMENTALEnicepatide Dose Level 2 administered SC once weekly.
Arm 4: Enicepatide Dose Level 3
EXPERIMENTALEnicepatide Dose Level 3 administered SC once weekly.
Arm 5: Enicepatide Dose Level 4
EXPERIMENTALEnicepatide Dose Level 4 administered SC once weekly.
Arm 6: Enicepatide Dose Level 5 (High)
EXPERIMENTALEnicepatide Dose Level 5 administered SC once weekly.
Interventions
Placebo will be volume- matched and administered subcutaneously (SC) once weekly.
Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carmot Therapeutics, Inc.lead
- Hoffmann-La Rochecollaborator
Study Sites (34)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Central Alabama Research
Homewood, Alabama, 35209, United States
The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
Mesa, Arizona, 85210, United States
Amicis Research Center - Anaheim
Anaheim, California, 92801, United States
Ark Clinical-Fountain Valley
Fountain Valley, California, 92708, United States
Ark Clinical Research - Long Beach
Long Beach, California, 90806, United States
Velocity Clinical Research - Los Angeles
Los Angeles, California, 90057, United States
Infinity Clinical Research
Norco, California, 92860, United States
Amicis Research Center
Northridge, California, 91324, United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730, United States
Orange County Research Center
Tustin, California, 92780, United States
Amicis Research Center - West Hills
West Hills, California, 91307, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Mercury Street Medical Group
Butte, Montana, 59701, United States
Neurobehavioral Research, Inc. (NBR)
Cedarhurst, New York, 11516, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818, United States
Tribe Clinical Research
Greenville, South Carolina, 29607, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731, United States
Apex Mobile Clinical Research
Bellaire, Texas, 77401, United States
Velocity Clinical Research - Dallas
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas, LLC
Dallas, Texas, 75231, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
Elevate Clinical
Seabrook, Texas, 77586, United States
Impact Research Institute
Waco, Texas, 76710, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
National Clinical Research - Richmond, Inc
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Carmot Therapeutics, Inc., a Member of the Roche Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2024
First Posted
July 29, 2024
Study Start
August 16, 2024
Primary Completion
December 8, 2025
Study Completion
December 8, 2025
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share