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

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 Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Placebo; Drug: Enicepatide

• Study Type: Interventional
• Enrollment (Actual): 469
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC
    • Homewood, Alabama, United States, 35209
      • Central Alabama Research
  • Arizona
    • Mesa, Arizona, United States, 85210
      • The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
  • California
    • Anaheim, California, United States, 92801
      • Amicis Research Center - Anaheim
    • Fountain Valley, California, United States, 92708
      • Ark Clinical-Fountain Valley
    • Long Beach, California, United States, 90806
      • Ark Clinical Research - Long Beach
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research - Los Angeles
    • Norco, California, United States, 92860
      • Infinity Clinical Research
    • Northridge, California, United States, 91324
      • Amicis Research Center
    • Rancho Cucamonga, California, United States, 91730
      • Prospective Research Innovations Inc.
    • Tustin, California, United States, 92780
      • Orange County Research Center
    • West Hills, California, United States, 91307
      • Amicis Research Center - West Hills
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research, Inc.
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group
  • New York
    • Cedarhurst, New York, United States, 11516
      • Neurobehavioral Research, Inc. (NBR)
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research, Inc
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research - Cincinnati
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes & Endocrinology, P.A.
    • Bellaire, Texas, United States, 77401
      • Apex Mobile Clinical Research
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Research - Dallas
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas, LLC
    • San Antonio, Texas, United States, 78229
      • Pinnacle Clinical Research
    • Seabrook, Texas, United States, 77586
      • Elevate Clinical
    • Waco, Texas, United States, 76710
      • Impact Research Institute
  • Utah
    • St. George, Utah, United States, 84790
      • Chrysalis Clinical Research
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research - Richmond, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1: Placebo; Placebo administered subcutaneously (SC) once weekly.	Drug: Placebo; Placebo will be volume- matched and administered subcutaneously (SC) once weekly.
Experimental: Arm 2: Enicepatide Dose Level 1 (Low); Enicepatide Dose Level 1 administered SC once weekly.	Drug: Enicepatide; Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.; Other Names: RO7795068; RG6640; CT-388
Experimental: Arm 3: Enicepatide Dose Level 2; Enicepatide Dose Level 2 administered SC once weekly.	Drug: Enicepatide; Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.; Other Names: RO7795068; RG6640; CT-388
Experimental: Arm 4: Enicepatide Dose Level 3; Enicepatide Dose Level 3 administered SC once weekly.	Drug: Enicepatide; Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.; Other Names: RO7795068; RG6640; CT-388
Experimental: Arm 5: Enicepatide Dose Level 4; Enicepatide Dose Level 4 administered SC once weekly.	Drug: Enicepatide; Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.; Other Names: RO7795068; RG6640; CT-388
Experimental: Arm 6: Enicepatide Dose Level 5 (High); Enicepatide Dose Level 5 administered SC once weekly.	Drug: Enicepatide; Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.; Other Names: RO7795068; RG6640; CT-388

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Body Weight from Baseline to Week 48	Baseline to Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in Hip Circumference from Baseline to Week 48	Baseline to Week 48
Change in Waist-to-Hip Ratio 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 Glycated Hemoglobin (HbA1c) 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
Change in Fasting C-peptide from Baseline to Week 48	Baseline to 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
Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c	Baseline and Week 48

Collaborators and Investigators

• Sponsor: Carmot Therapeutics, Inc.
• Collaborators: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Carmot Therapeutics, Inc., a Member of the Roche Group

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2024
• Primary Completion (Actual): December 8, 2025
• Study Completion (Actual): December 8, 2025

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: CT-388-103; XC45526 (Other Identifier: Roche Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No