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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Arm 1: Placebo
  • Drug: Placebo
    Placebo will be volume-matched and administered subcutaneously (SC) once weekly.
Experimental
Arm 2: CT-388 Dose Level 1 (Low)
  • Drug: CT-388
    CT-388 will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.
Experimental
Arm 3: CT-388 Dose Level 2
  • Drug: CT-388
    CT-388 will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.
Experimental
Arm 4: CT-388 Dose Level 3
  • Drug: CT-388
    CT-388 will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.
Experimental
Arm 5: CT-388 Dose Level 4 (High)
  • Drug: CT-388
    CT-388 will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

Recruiting Locations

University of Alabama at Birmingham (UAB)
Birmingham, Alabama 35233

More Details

Status
Recruiting
Sponsor
Carmot Therapeutics, Inc.

Study Contact

Reference Study ID: CT-388-104 Roche Study ID: XC45544
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.