A Study of CT-388 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

Phase 2

Active, not recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: Placebo; Drug: CT-388

• Registration Number: NCT06525935
• 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 with obesity or who are overweight with at least one weight-related comorbidity.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-23
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-29
• Study Start: 2024-08-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-17
• Primary Completion: 2026-01-17
• Study Completion: 2026-02-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Male or female, 18 to 75 years of age
• Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and <30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
• At least one self-reported unsuccessful effort to lose body weight

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Exclusion Criteria

• Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state
• Self-reported body weight change of >5 kg within 3 months before randomization
• Any unbalanced/extreme 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
• Serum calcitonin ≥ 20 ng/L
• Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Placebo	Placebo	Placebo administered subcutaneously (SC) once weekly.
Arm 2: CT-388 Dose Level 1 (Low)	CT-388	CT-388 Dose Level 1 administered SC once weekly.
Arm 3: CT-388 Dose Level 2	CT-388	CT-388 Dose Level 2 administered SC once weekly.
Arm 4: CT-388 Dose Level 3	CT-388	CT-388 Dose Level 3 administered SC once weekly.
Arm 5: CT-388 Dose Level 4	CT-388	CT-388 Dose Level 4 administered SC once weekly.
Arm 6: CT-388 Dose Level 5 (High)	CT-388	CT-388 Dose Level 5 administered SC once weekly.

Primary Outcome Measures

Name	Time	Method
Percent Change in Body Weight from Baseline to Week 48	48 Weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48	48 Weeks
Absolute Change in Body Weight (kg) from Baseline to Week 48	48 weeks
Percent Change in Body Weight from Baseline to Week 48 by Obesity Class	48 weeks
Change from Baseline to Week 48 in body weight-related parameters (Body Mass Index, waist circumference, hip circumference, waist-to-hip ratio, and waist-to-height ratio)	48 weeks
Change from Baseline to Week 48 in markers of glucose metabolism	48 weeks
Proportion of patients with normoglycemia, prediabetes, and diabetes at baseline and Week 48	48 Weeks
Number of participants with at least one Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), Adverse Event of Special Interest (AESI), AE leading to study drug discontinuation	53 Weeks
Treatment-Emergent Adverse Events (TEAEs) That Occurred in >10% of Enrolled Participants	53 Weeks
Number of Participants with Documented Hypoglycemia	53 Weeks
Change from Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score	53 Weeks
Number of participants with Columbia Suicide Severity Rating Scale (C-SSRS) Events from Baseline through 53 Weeks	53 Weeks
Change from Baseline in safety laboratory values, vital signs, and electrocardiograms	53 Weeks

Trial Locations

Locations (34)

Alabama Clinical Therapeutics, LLC; 🇺🇸 Birmingham, Alabama, United States

Central Alabama Research; 🇺🇸 Homewood, Alabama, United States

The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health; 🇺🇸 Mesa, Arizona, United States

Amicis Research Center - Anaheim; 🇺🇸 Anaheim, California, United States

Ark Clinical-Fountain Valley; 🇺🇸 Fountain Valley, California, United States

Ark Clinical Research - Long Beach; 🇺🇸 Long Beach, California, United States

Velocity Clinical Research - Los Angeles; 🇺🇸 Los Angeles, California, United States

Infinity Clinical Research; 🇺🇸 Norco, California, United States

Amicis Research Center; 🇺🇸 Northridge, California, United States

Prospective Research Innovations Inc.; 🇺🇸 Rancho Cucamonga, California, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

Amicis Research Center - West Hills; 🇺🇸 West Hills, California, United States

Tampa Bay Medical Research, Inc.; 🇺🇸 Clearwater, Florida, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Louisville Metabolic and Atherosclerosis Research Center (L-MARC); 🇺🇸 Louisville, Kentucky, United States

The Center for Pharmaceutical Research; 🇺🇸 Kansas City, Missouri, United States

Mercury Street Medical Group; 🇺🇸 Butte, Montana, United States

Neurobehavioral Research, Inc. (NBR); 🇺🇸 Cedarhurst, New York, United States

Lucas Research, Inc; 🇺🇸 Morehead City, North Carolina, United States

Velocity Clinical Research - Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Velocity Clinical Research, Providence; 🇺🇸 East Greenwich, Rhode Island, United States

Tribe Clinical Research; 🇺🇸 Greenville, South Carolina, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Knoxville, Tennessee, United States

Clinical Research Associates, Inc.; 🇺🇸 Nashville, Tennessee, United States

Texas Diabetes & Endocrinology, P.A.; 🇺🇸 Austin, Texas, United States

Apex Mobile Clinical Research; 🇺🇸 Bellaire, Texas, United States

Velocity Clinical Research - Dallas; 🇺🇸 Dallas, Texas, United States

FutureSearch Trials of Dallas, LLC; 🇺🇸 Dallas, Texas, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States

Elevate Clinical; 🇺🇸 Seabrook, Texas, United States

Impact Research Institute; 🇺🇸 Waco, Texas, United States

Chrysalis Clinical Research; 🇺🇸 St. George, Utah, United States

National Clinical Research - Richmond, Inc; 🇺🇸 Richmond, Virginia, United States