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ACTIVE NOT RECRUITING

NCT06628362

PHASE2

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

Sponsor: Carmot Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2024-11-21

Completion Date

2026-11-30

Last Updated

2026-01-07

Healthy Volunteers

Conditions

Overweight or Obese Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Placebo

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

DRUG

CT-388

CT-388 will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

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

Locations (70)

Central Alabama Research

Birmingham, Alabama, United States

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Lakeview Clinical Research, LLC

Guntersville, Alabama, United States

Yuma Clinical Trials

Yuma, Arizona, United States

AMCR Institute

Escondido, California, United States

Ark Clinical-Fountain Valley

Fountain Valley, California, United States

Orange Country Research Center

Lake Forest, California, United States

Ark Clinical Research

Long Beach, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Asclepes Research Centers

Sherman Oaks, California, United States

Encompass Clinical Research

Spring Valley, California, United States

Flourish Research - Boca Raton

Boca Raton, Florida, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

K2 Medical Research, LLC - Maitland

Maitland, Florida, United States

K2 Medical Research, LLC - Orlando

Maitland, Florida, United States

Flourish Research Acquisition, LLC

Miami, Florida, United States

K2 Medical Research, LLC - South Orlando

Orlando, Florida, United States

Aging Well Associates

St. Petersburg, Florida, United States

K2 Medical Research Tampa

Tampa, Florida, United States

K2 Summit Research

The Villages, Florida, United States

Privia Medical Group Georgia, LLC

Fayetteville, Georgia, United States

Privia Medical Group Georgia - Thomasville

Thomasville, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Duly Health and Care

Lombard, Illinois, United States

McFarland Clinic

Ames, Iowa, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

NOLA Cares, LLC

Metairie, Louisiana, United States

Flourish Research Acquisition, LLC dba Flourish Bowie

Bowie, Maryland, United States

Centennial Medical Group

Elkridge, Maryland, United States

NECCR PrimaCare Research LLC

Fall River, Massachusetts, United States

Olive Branch Family Medical Center; Family Medicine

Olive Branch, Mississippi, United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Ellipsis Research Group

Brooklyn, New York, United States

Accellacare of Cary

Cary, North Carolina, United States

Accellacare - Hickory

Hickory, North Carolina, United States

Accellacare of Rocky Mount

Rocky Mount, North Carolina, United States

Accellacare of Piedmont Healthcare

Statesville, North Carolina, United States

Accellacare of Wilmington, LLC

Wilmington, North Carolina, United States

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, United States

Diabetes and Endocrinology Associates of Stark County, Inc.

Canton, Ohio, United States

Tekton Research

Edmond, Oklahoma, United States

Roper St. Francis Physician Partners - Primary Care

Mt. Pleasant, South Carolina, United States

Norwood Family Medicine

Knoxville, Tennessee, United States

Summit-Halls Family Practice

Knoxville, Tennessee, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Velocity Clinical Research - Dallas

Dallas, Texas, United States

University of Texas Southwestern Medical Center Investigation Drug Services

Dallas, Texas, United States

Juno Research, LLC

Houston, Texas, United States

Consano Clinical Research

Shavano Park, Texas, United States

Privia Medical Group North Texas - Stephenville

Stephenville, Texas, United States

Manassas Clinical Research Center

Manassas, Virginia, United States

Centro Medico Viamonte SRL

Buenos Aires, Provincia de Buenos, Argentina

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Aggarwal and Associates

Brampton, Ontario, Canada

CEMDEC S.A. de C.V.

Cuauhtémoc, Mexico

Instituto de Diabetes Obesidad y Nutricion, SC

Cuernavaca, Mexico

SINACOR

Culiacán, Mexico

Centro De Investigacion En Artritis Y Osteopososis

Mexicali, Mexico

Clinicos Asociados Bocm, S.C.

Mexico City, Mexico

Medical Care and Research S.A de C.V

Mérida, Mexico

Avant Santé Research Center

San Pedro Garza García, Mexico

Sociedad de Metabolismo y Corazon S.C.

Veracruz, Mexico

FAICIC S de R.L. de C.V

Veracruz, Mexico

Optimal Clinical Trials - North

Rosedale, Auckland, New Zealand

Momentum Pukekohe

Auckland, New Zealand

Optimal Clinical Trials

Grafton, New Zealand

Tauranga Hospital

Tauranga, New Zealand

Momentum Wellington

Wellington, New Zealand

ISIS Clinical Research Center

Guaynabo, Puerto Rico