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

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).

Conditions

Overweight or Obese, Type 2 Diabetes Mellitus (T2DM)

Study Overview

Study Details

Study overview

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).

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

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

Condition
Overweight or Obese
Intervention / Treatment

-

Contacts and Locations

Guntersville

Lakeview Clinical Research, LLC, Guntersville, Alabama, United States, 35976

Maitland

K2 Medical Research, LLC, Maitland, Florida, United States, 32751

Orlando

K2 Medical Research, LLC, Orlando, Florida, United States, 32751

Tampa

K2 Medical Research Tampa, Tampa, Florida, United States, 33607

The Villages

K2 Summit Research, The Villages, Florida, United States, 32159

Cary

Accellacare of Cary, Cary, North Carolina, United States, 27518

Hickory

Accellacare - Hickory, Hickory, North Carolina, United States, 28601

Rocky Mount

Accellacare of Rocky Mount, Rocky Mount, North Carolina, United States, 27804

Statesville

Accellacare of Piedmont Healthcare, Statesville, North Carolina, United States, 28625

Winston Salem

Accellacare Research of Winston Salem, Winston Salem, North Carolina, United States, 27103

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 or diet and exercise and treatment with 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, non-proliferative diabetic retinopathy that requires acute treatment
  • * Have presence of active neuropathy (including 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 participation in an organized weight reduction program
  • * 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 for obesity
  • * Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility
  • * History of chronic pancreatitis or acute pancreatitis within 6 months before screening
  • * Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
  • * History of major depressive disorder within 2 years of screening
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Carmot Therapeutics, Inc.,

Clinical Trials, STUDY_DIRECTOR, Carmot Therapeutics, Inc., a Member of the Roche Group

Study Record Dates

2026-05-31