A Study of Enicepatide (CT-388) in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

April 14, 2026 updated by: Carmot Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
469

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change in Body Weight from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
Time Frame: Baseline and Week 48
Baseline and Week 48
Absolute Change in Body Weight (kg) from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Percent Change in Body Weight from Baseline to Week 48 by Obesity Class
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Body Mass Index (BMI) from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Waist Circumference from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Hip Circumference from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Waist-to-Hip Ratio from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Waist-to-Height Ratio from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Fasting Plasma Glucose from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Fasting Insulin from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in Fasting C-peptide from Baseline to Week 48
Time Frame: Baseline to Week 48
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
Baseline to Week 48
Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48
Time Frame: 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
Time Frame: Baseline and Week 48
Baseline and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Carmot Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Carmot Therapeutics, Inc., a Member of the Roche Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings