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ACTIVE_NOT_RECRUITINGPHASE2

A Study of 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

NCT06628362•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).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

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

Key Dates

Start Date

November 21, 2024

Primary Completion Date

August 10, 2026

Completion Date

November 30, 2026

Last Updated

January 7, 2026

Enrollment

360

ESTIMATED participants

Conditions

Overweight or ObeseType 2 Diabetes Mellitus (T2DM)

Interventions

Placebo

DRUG

CT-388

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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