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

NCT06628362 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: CT-388-104XC45544
• Study Type: interventional
• Target: 360
• Locations: 6 countries
• Sites: 70

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

Conditions

Overweight or Obese; Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (24)

• 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

• Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48

  Baseline and Week 48

Study Arms (5)

Arm 1: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Arm 2: Enicepatide Dose Level 1 (Low)

EXPERIMENTAL

Drug: Enicepatide

Arm 3: Enicepatide Dose Level 2

EXPERIMENTAL

Drug: Enicepatide

Arm 4: Enicepatide Dose Level 3

EXPERIMENTAL

Drug: Enicepatide

Arm 5: Enicepatide Dose Level 4 (High)

EXPERIMENTAL

Drug: Enicepatide

Interventions

Placebo DRUG

Placebo will be volume-matched and administered subcutaneously (SC) once weekly.

Arm 1: Placebo

Enicepatide DRUG

Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

Also known as: CT-388, RO7795068, RG6640

Arm 2: Enicepatide Dose Level 1 (Low); Arm 3: Enicepatide Dose Level 2; Arm 4: Enicepatide Dose Level 3; Arm 5: Enicepatide Dose Level 4 (High)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmot Therapeutics, Inc.: lead
• Hoffmann-La Roche: collaborator

Study Sites (70)

Central Alabama Research

Birmingham, Alabama, 35209-8401, United States

Location

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233, United States

Location

Lakeview Clinical Research, LLC

Guntersville, Alabama, 35976, United States

Location

Yuma Clinical Trials

Yuma, Arizona, 85364, United States

Location

AMCR Institute

Escondido, California, 92025, United States

Location

Ark Clinical-Fountain Valley

Fountain Valley, California, 92708, United States

Location

Orange Country Research Center

Lake Forest, California, 92630, United States

Location

Ark Clinical Research

Long Beach, California, 90806, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Asclepes Research Centers

Sherman Oaks, California, 91403, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Flourish Research - Boca Raton

Boca Raton, Florida, 33434, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

K2 Medical Research, LLC - Maitland

Maitland, Florida, 32751, United States

Location

K2 Medical Research, LLC - Orlando

Maitland, Florida, 32751, United States

Location

Flourish Research Acquisition, LLC

Miami, Florida, 33138, United States

Location

K2 Medical Research, LLC - South Orlando

Orlando, Florida, 32806, United States

Location

Aging Well Associates

St. Petersburg, Florida, 33713, United States

Location

K2 Medical Research Tampa

Tampa, Florida, 33607, United States

Location

K2 Summit Research

The Villages, Florida, 32159, United States

Location

Privia Medical Group Georgia, LLC

Fayetteville, Georgia, 30214, United States

Location

Privia Medical Group Georgia - Thomasville

Thomasville, Georgia, 31792, United States

Location

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291, United States

Location

Duly Health and Care

Lombard, Illinois, 60148, United States

Location

McFarland Clinic

Ames, Iowa, 50010, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

NOLA Cares, LLC

Metairie, Louisiana, 70006, United States

Location

Flourish Research Acquisition, LLC dba Flourish Bowie

Bowie, Maryland, 20715, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

NECCR PrimaCare Research LLC

Fall River, Massachusetts, 02721, United States

Location

Olive Branch Family Medical Center; Family Medicine

Olive Branch, Mississippi, 38654, United States

Location

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Ellipsis Research Group

Brooklyn, New York, 11215, United States

Location

Accellacare of Cary

Cary, North Carolina, 27518, United States

Location

Accellacare - Hickory

Hickory, North Carolina, 28601, United States

Location

Accellacare of Rocky Mount

Rocky Mount, North Carolina, 27804, United States

Location

Accellacare of Piedmont Healthcare

Statesville, North Carolina, 28625, United States

Location

Accellacare of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, 27103, United States

Location

Diabetes and Endocrinology Associates of Stark County, Inc.

Canton, Ohio, 44718, United States

Location

Tekton Research

Edmond, Oklahoma, 73013, United States

Location

Roper St. Francis Physician Partners - Primary Care

Mt. Pleasant, South Carolina, 29464, United States

Location

Norwood Family Medicine

Knoxville, Tennessee, 37912, United States

Location

Summit-Halls Family Practice

Knoxville, Tennessee, 37938, United States

Location

FutureSearch Trials of Neurology

Austin, Texas, 78731, United States

Location

Velocity Clinical Research - Dallas

Dallas, Texas, 75230, United States

Location

University of Texas Southwestern Medical Center Investigation Drug Services

Dallas, Texas, 75390, United States

Location

Juno Research, LLC

Houston, Texas, 77040, United States

Location

Consano Clinical Research

Shavano Park, Texas, 78231, United States

Location

Privia Medical Group North Texas - Stephenville

Stephenville, Texas, 76401, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Centro Medico Viamonte SRL

Buenos Aires, Provincia de Buenos, 1120, Argentina

Location

Centricity Research Brampton Endocrinology

Brampton, Ontario, L6S 0C6, Canada

Location

Aggarwal and Associates

Brampton, Ontario, L6T 0G1, Canada

Location

CEMDEC S.A. de C.V.

Cuauhtémoc, 06100, Mexico

Location

Instituto de Diabetes Obesidad y Nutricion, SC

Cuernavaca, 62250, Mexico

Location

SINACOR

Culiacán, 80230, Mexico

Location

Centro De Investigacion En Artritis Y Osteopososis

Mexicali, 21200, Mexico

Location

Clinicos Asociados Bocm, S.C.

Mexico City, 03300, Mexico

Location

Medical Care and Research S.A de C.V

Mérida, 97070, Mexico

Location

Avant Santé Research Center

San Pedro Garza García, 66260, Mexico

Location

Sociedad de Metabolismo y Corazon S.C.

Veracruz, 91855, Mexico

Location

FAICIC S de R.L. de C.V

Veracruz, 91900, Mexico

Location

Optimal Clinical Trials - North

Rosedale, Auckland, 0632, New Zealand

Location

Momentum Pukekohe

Auckland, 2120, New Zealand

Location

Optimal Clinical Trials

Grafton, 1010, New Zealand

Location

Tauranga Hospital

Tauranga, 3110, New Zealand

Location

Momentum Wellington

Wellington, 6021, New Zealand

Location

ISIS Clinical Research Center

Guaynabo, 00970, Puerto Rico

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Trials

  Carmot Therapeutics, Inc., a Member of the Roche Group

  STUDY DIRECTOR

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: October 3, 2024
• First Posted: October 8, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); NZ (5); AR (1); ME (9); US (52); CA (2)