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

Phase 2

Recruiting

• Conditions: Overweight or Obese; Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: Placebo; Drug: CT-388

• Registration Number: NCT06628362
• Lead Sponsor: Carmot Therapeutics, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Study Start: 2024-11-21
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-10
• Primary Completion: 2026-08-10
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Placebo	Placebo	-
Arm 2: CT-388 Dose Level 1 (Low)	CT-388	-
Arm 3: CT-388 Dose Level 2	CT-388	-
Arm 4: CT-388 Dose Level 3	CT-388	-
Arm 5: CT-388 Dose Level 4 (High)	CT-388	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Body Weight from Baseline to Week 36	Baseline to Week 36
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36	Baseline to Week 36

Secondary Outcome Measures

Name	Time	Method
Percent Change in Body Weight from Baseline to Week 48	Baseline to Week 48
Change in HbA1c from Baseline to Week 48	Baseline to Week 48
Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48	Weeks 36 and 48
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36	Baseline and Week 36
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48	Baseline and Week 48
Percent Change in Body Weight from Baseline to Week 28	Baseline and Week 28
Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48	Baseline to Weeks 36 and 48
Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class	Baseline to Weeks 16, 28, 36, and 48
Change in HbA1c from Baseline to Weeks 16 and 28	Baseline to Weeks 16 and 28
Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class	Baseline to Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48	Weeks 16, 28, 36, and 48
Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48	Weeks 16, 28, 36, and 48
Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48	Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48	Baseline, Weeks 16, 28, 36, and 48
Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48	Baseline, Weeks 16, 28, 36, and 48
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Waist Circumference from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Hip Circumference from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48	Baseline, Weeks 36 and 48
Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48	Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48	Baseline to Weeks 16, 28, 36, and 48
Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48	Baseline to Weeks 16, 28, 36, and 48
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48	Baseline to Weeks 16, 28, 36, and 48

Trial Locations

Locations (58)

Pinnacle Research Group, Llc; Central; 🇺🇸 Anniston, Alabama, United States

University of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States

Lakeview Clinical Research, LLC; 🇺🇸 Guntersville, Alabama, United States

AMCR Institute; 🇺🇸 Escondido, 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

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

Excel Medical Clinical Trials, LLC; 🇺🇸 Boca Raton, Florida, United States

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