ACTIVE_NOT_RECRUITING

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

Conditions

Overweight or Obese Type 2 Diabetes Mellitus (T2DM)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-11-21

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06628362

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

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

Study Locations (Sites)

Central Alabama Research

Birmingham, Alabama, 35209-8401

United States

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35233

United States

Lakeview Clinical Research, LLC

Guntersville, Alabama, 35976

United States

Yuma Clinical Trials

Yuma, Arizona, 85364

United States

AMCR Institute

Escondido, California, 92025

United States

Ark Clinical-Fountain Valley

Fountain Valley, California, 92708

United States

Orange Country Research Center

Lake Forest, California, 92630

United States

Ark Clinical Research

Long Beach, California, 90806

United States

Catalina Research Institute, LLC

Montclair, California, 91763

United States

Asclepes Research Centers

Sherman Oaks, California, 91403

United States

Encompass Clinical Research

Spring Valley, California, 91978

United States

Flourish Research - Boca Raton

Boca Raton, Florida, 33434

United States

Tampa Bay Medical Research

Clearwater, Florida, 33761

United States

K2 Medical Research, LLC - Maitland

Maitland, Florida, 32751

United States

K2 Medical Research, LLC - Orlando

Maitland, Florida, 32751

United States

Flourish Research Acquisition, LLC

Miami, Florida, 33138

United States

K2 Medical Research, LLC - South Orlando

Orlando, Florida, 32806

United States

Aging Well Associates

St. Petersburg, Florida, 33713

United States

K2 Medical Research Tampa

Tampa, Florida, 33607

United States

K2 Summit Research

The Villages, Florida, 32159

United States

Privia Medical Group Georgia, LLC

Fayetteville, Georgia, 30214

United States

Privia Medical Group Georgia - Thomasville

Thomasville, Georgia, 31792

United States

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, 30291

United States

Duly Health and Care

Lombard, Illinois, 60148

United States

McFarland Clinic

Ames, Iowa, 50010

United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606

United States

NOLA Cares, LLC

Metairie, Louisiana, 70006

United States

Flourish Research Acquisition, LLC dba Flourish Bowie

Bowie, Maryland, 20715

United States

Centennial Medical Group

Elkridge, Maryland, 21075

United States

NECCR PrimaCare Research LLC

Fall River, Massachusetts, 02721

United States

Olive Branch Family Medical Center; Family Medicine

Olive Branch, Mississippi, 38654

United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Ellipsis Research Group

Brooklyn, New York, 11215

United States

Accellacare of Cary

Cary, North Carolina, 27518

United States

Accellacare - Hickory

Hickory, North Carolina, 28601

United States

Accellacare of Rocky Mount

Rocky Mount, North Carolina, 27804

United States

Accellacare of Piedmont Healthcare

Statesville, North Carolina, 28625

United States

Accellacare of Wilmington, LLC

Wilmington, North Carolina, 28401

United States

Accellacare Research of Winston Salem

Winston-Salem, North Carolina, 27103

United States

Diabetes and Endocrinology Associates of Stark County, Inc.

Canton, Ohio, 44718

United States

Tekton Research

Edmond, Oklahoma, 73013

United States

Roper St. Francis Physician Partners - Primary Care

Mt. Pleasant, South Carolina, 29464

United States

Norwood Family Medicine

Knoxville, Tennessee, 37912

United States

Summit-Halls Family Practice

Knoxville, Tennessee, 37938

United States

FutureSearch Trials of Neurology

Austin, Texas, 78731

United States

Velocity Clinical Research - Dallas

Dallas, Texas, 75230

United States

University of Texas Southwestern Medical Center Investigation Drug Services

Dallas, Texas, 75390

United States

Juno Research, LLC

Houston, Texas, 77040

United States

Consano Clinical Research

Shavano Park, Texas, 78231

United States

Privia Medical Group North Texas - Stephenville

Stephenville, Texas, 76401

United States

Manassas Clinical Research Center

Manassas, Virginia, 20110

United States

Collaborators and Investigators

Sponsor: Carmot Therapeutics, Inc.

Clinical Trials, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-11-21

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2024-11-21

Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

Overweight or Obese
Type 2 Diabetes Mellitus (T2DM)