A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

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 Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

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 who are overweight or obese with Type 2 diabetes mellitus (T2DM).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 (Estimated)

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.
360

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

  • Argentina
    • Provincia de Buenos
      • Buenos Aires, Provincia de Buenos, Argentina, 1120
        • Centro Medico Viamonte SRL
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
        • Aggarwal and Associates
      • Brampton, Ontario, Canada, L6S 0C6
        • Centricity Research Brampton Endocrinology
  • Mexico
      • Cuauhtémoc, Mexico, 06100
        • CEMDEC S.A. de C.V.
      • Cuernavaca, Mexico, 62250
        • Instituto de Diabetes Obesidad y Nutricion, SC
      • Culiacán, Mexico, 80230
        • SINACOR
      • Mexicali, Mexico, 21200
        • Centro De Investigacion En Artritis Y Osteopososis
      • Mexico City, Mexico, 03300
        • Clinicos Asociados Bocm, S.C.
      • Mérida, Mexico, 97070
        • Medical Care and Research S.A de C.V
      • San Pedro Garza García, Mexico, 66260
        • Avant Sante Research Center
      • Veracruz, Mexico, 91900
        • FAICIC S de R.L. de C.V
      • Veracruz, Mexico, 91855
        • Sociedad de Metabolismo y Corazón S.C.
  • New Zealand
      • Auckland, New Zealand, 2120
        • Momentum Pukekohe
      • Grafton, New Zealand, 1010
        • Optimal Clinical Trials
      • Tauranga, New Zealand, 3110
        • Tauranga Hospital
      • Wellington, New Zealand, 6021
        • Momentum Wellington
    • Auckland
      • Rosedale, Auckland, New Zealand, 0632
        • Optimal Clinical Trials - North
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00970
        • Isis Clinical Research Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209-8401
        • Central Alabama Research
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham (UAB)
      • Guntersville, Alabama, United States, 35976
        • Lakeview Clinical Research, LLC
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Yuma Clinical Trials
    • California
      • Escondido, California, United States, 92025
        • AMCR Institute
      • Fountain Valley, California, United States, 92708
        • Ark Clinical-Fountain Valley
      • Lake Forest, California, United States, 92630
        • Orange Country Research Center
      • Long Beach, California, United States, 90806
        • Ark Clinical Research
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • Sherman Oaks, California, United States, 91403
        • Asclepes Research Centers
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Flourish Research - Boca Raton
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research
      • Maitland, Florida, United States, 32751
        • K2 Medical Research, LLC - Maitland
      • Maitland, Florida, United States, 32751
        • K2 Medical Research, LLC - Orlando
      • Miami, Florida, United States, 33138
        • Flourish Research Acquisition, LLC
      • Orlando, Florida, United States, 32806
        • K2 Medical Research, LLC - South Orlando
      • St. Petersburg, Florida, United States, 33713
        • Aging Well Associates
      • Tampa, Florida, United States, 33607
        • K2 Medical Research Tampa
      • The Villages, Florida, United States, 32159
        • K2 Summit Research
    • Georgia
      • Fayetteville, Georgia, United States, 30214
        • Privia Medical Group Georgia, LLC
      • Thomasville, Georgia, United States, 31792
        • Privia Medical Group Georgia - Thomasville
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Illinois
      • Lombard, Illinois, United States, 60148
        • Duly Health and Care
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • NOLA Cares, LLC
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Flourish Research Acquisition, LLC dba Flourish Bowie
      • Elkridge, Maryland, United States, 21075
        • Centennial Medical Group
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • NECCR PrimaCare Research LLC
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Olive Branch Family Medical Center; Family Medicine
      • Ridgeland, Mississippi, United States, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New York
      • Brooklyn, New York, United States, 11215
        • Ellipsis Research Group
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Accellacare of Cary
      • Hickory, North Carolina, United States, 28601
        • Accellacare - Hickory
      • Rocky Mount, North Carolina, United States, 27804
        • Accellacare of Rocky Mount
      • Statesville, North Carolina, United States, 28625
        • Accellacare of Piedmont HealthCare
      • Wilmington, North Carolina, United States, 28401
        • Accellacare of Wilmington, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Accellacare Research of Winston Salem
    • Ohio
      • Canton, Ohio, United States, 44718
        • Diabetes and Endocrinology Associates of Stark County, Inc.
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Tekton Research
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Roper St. Francis Physician Partners - Primary Care
    • Tennessee
      • Knoxville, Tennessee, United States, 37912
        • Norwood Family Medicine
      • Knoxville, Tennessee, United States, 37938
        • Summit-Halls Family Practice
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research - Dallas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center Investigation Drug Services
      • Houston, Texas, United States, 77040
        • Juno Research, LLC
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research
      • Stephenville, Texas, United States, 76401
        • Privia Medical Group North Texas - Stephenville
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center

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) ≥25.0 kg/m^2
  • Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World Health Organization classification or other locally applicable standards
  • Have an HbA1c ≥7% and ≤10.5%
  • Management of T2DM with diet and exercise alone, metformin, or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, as monotherapy or in combination, per approved local label
  • At least one self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

  • Have Type 1 Diabetes Mellitus (T1DM), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
  • Have had 1 or more episodes of Level 3 hypoglycemia or have had hypoglycemia unawareness within 3 months prior to screening
  • Have history or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
  • Have evidence of clinically significant autonomic neuropathy (symptoms may include resting tachycardia, orthostatic hypotension, or diabetic diarrhea)
  • Had treatment with any oral antihyperglycemic medications, with the exception of metformin or SGLT-2 inhibitors, within 3 months prior to screening or planned concurrent treatment with these medications during the study
  • Had treatment with injectable antihyperglycemic medication, with the exception of short-term insulin, within 6 months prior to screening or planned concurrent treatment with these medications during the study
  • Self-reported body weight change of >5 kg within 3 months before screening
  • Any unbalanced/extreme diets, such as very low calorie, low carbohydrate, very high protein, ketogenic, or intermittent diets, within 3 months of the screening visit, or plan to be on such diets during the study
  • 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 or procedure for obesity, except for liposuction or abdominoplasty if performed >1 year prior to screening. Participants with a history of devices, such as LAP-BAND® or intragastric balloon, are permitted, if devices were removed >1 year prior to screening.
  • History of clinically significant or active gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction, intestinal obstruction), or chronic use of medications that directly affect GI motility
  • History of chronic pancreatitis or acute pancreatitis or have signs and symptoms of acute pancreatitis at screening
  • Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
  • History or diagnosis of significant active or unstable major depressive disorder or any history/diagnosis of other severe psychiatric conditions (e.g., schizophrenia; bipolar disorder; other serious mood disorder or anxiety disorder, or hyperactivity disorder) within the last year before screening
  • History of any hematologic conditions that may interfere with HbA1c measurement (e.g., hemolytic anemias, sickle cell disease, other hemoglobinopathies)
  • Family or personal history of medullary thyroid carcinoma
  • Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method as required per protocol

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
Drug: Placebo
Placebo will be volume-matched and administered subcutaneously (SC) once weekly.
Experimental: Arm 2: Enicepatide Dose Level 1 (Low)
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
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
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 (High)
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 36
Time Frame: Baseline to Week 36
Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36
Time Frame: Baseline to Week 36
Baseline to Week 36

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
Percent Change in Body Weight from Baseline to Week 28
Time Frame: Baseline and Week 28
Baseline and Week 28
Percent Change in Body Weight from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Change in HbA1c from Baseline to Week 48
Time Frame: Baseline to Week 48
Baseline to Week 48
Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48
Time Frame: Weeks 36 and 48
Weeks 36 and 48
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36
Time Frame: Baseline and Week 36
Baseline and Week 36
Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48
Time Frame: Baseline to Weeks 36 and 48
Baseline to Weeks 36 and 48
Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Time Frame: Baseline to Weeks 16, 28, 36, and 48
Baseline to Weeks 16, 28, 36, and 48
Change in HbA1c from Baseline to Weeks 16 and 28
Time Frame: Baseline to Weeks 16 and 28
Baseline to Weeks 16 and 28
Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Time Frame: Baseline to Weeks 16, 28, 36, and 48
Baseline to Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48
Time Frame: Weeks 16, 28, 36, and 48
Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48
Time Frame: Weeks 16, 28, 36, and 48
Weeks 16, 28, 36, and 48
Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48
Time Frame: Weeks 16, 28, 36, and 48
Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48
Time Frame: Baseline, Weeks 16, 28, 36, and 48
Baseline, Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48
Time Frame: Baseline, Weeks 16, 28, 36, and 48
Baseline, Weeks 16, 28, 36, and 48
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48
Time Frame: Baseline, Weeks 36 and 48
Baseline, Weeks 36 and 48
Change in Waist Circumference from Baseline to Weeks 36 and 48
Time Frame: Baseline, Weeks 36 and 48
Baseline, Weeks 36 and 48
Change in Hip Circumference from Baseline to Weeks 36 and 48
Time Frame: Baseline, Weeks 36 and 48
Baseline, Weeks 36 and 48
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48
Time Frame: Baseline, Weeks 36 and 48
Baseline, Weeks 36 and 48
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48
Time Frame: Baseline, Weeks 36 and 48
Baseline, Weeks 36 and 48
Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48
Time Frame: Baseline to Weeks 16, 28, 36, and 48
Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48
Time Frame: Baseline to Weeks 16, 28, 36, and 48
Baseline to Weeks 16, 28, 36, and 48
Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48
Time Frame: Baseline to Weeks 16, 28, 36, and 48
Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48
Time Frame: Baseline to Weeks 16, 28, 36, and 48
Baseline to Weeks 16, 28, 36, and 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.
November 21, 2024

Primary Completion (Estimated)

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.
June 1, 2026

Study Completion (Estimated)

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.
September 24, 2026

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).
October 3, 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.
October 3, 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.
October 8, 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-388-104
  • XC45544 (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.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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