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

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

  • Overweight or Obese
  • Type 2 Diabetes Mellitus (T2DM)

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.
    Other names:
    • RO7795068
    • RG6640
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.
    Other names:
    • RO7795068
    • RG6640
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.
    Other names:
    • RO7795068
    • RG6640
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.
    Other names:
    • RO7795068
    • RG6640

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