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

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: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM); Overweight or Obese
• Intervention / Treatment: Drug: Placebo; Drug: Enicepatide

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Provincia de Buenos
    • Buenos Aires, Provincia de Buenos, Argentina, 1120
      • Centro Médico 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

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) ≥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

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Percent Change in Body Weight from Baseline to Week 36	Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36	Baseline to Week 36

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
Percent Change in Body Weight from Baseline to Week 28	Baseline and Week 28
Percent Change in Body Weight from Baseline to Week 48	Baseline to Week 48
Change in HbA1c from Baseline to Week 48	Baseline to Week 48
Percentage of Participants with HbA1c <7.0% at 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	Baseline and Week 36
Absolute Change in Body Weight (kg) from 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	Baseline to Weeks 16, 28, 36, and 48
Change in HbA1c from 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	Baseline to Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c ≤6.5% at 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	Weeks 16, 28, 36, and 48
Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at 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	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	Baseline, Weeks 16, 28, 36, and 48
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Waist Circumference from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Hip Circumference from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Fasting Plasma Glucose from 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	Baseline to Weeks 16, 28, 36, and 48
Change in Fasting C-peptide from 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	Baseline to Weeks 16, 28, 36, and 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): November 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 24, 2026

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 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: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID 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