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

Last updated: February 13, 2025
Sponsor: Carmot Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Placebo

CT-388

Clinical Study ID

NCT06525935
CT-388-103
XC45526
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 previouslydiagnosed with at least 1 of the following weight-related comorbidities, such as:prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovasculardisease

  • At least one self-reported unsuccessful effort to lose body weight

Exclusion

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 beon 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 glucosemetabolism

  • 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, orchronic use of medications that directly affect GI motility

  • History of chronic pancreatitis or acute pancreatitis within 6 months beforescreening

  • Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) ordiagnosed monogenetic or syndromic forms of obesity

  • History of major depressive disorder within 2 years of screening, or anyhistory/diagnosis of other severe psychiatric conditions (Note: Prospectiveparticipants with depression or anxiety whose disease state, in the opinion of theInvestigator, is considered stable and expected to remain stable throughout thecourse of the study, may be considered for inclusion)

  • 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 ofchildbearing potential and not using a highly effective contraceptive method

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 16, 2024
Estimated Completion Date:
February 21, 2026

Connect with a study center

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • Central Alabama Research

    Homewood, Alabama 35209
    United States

    Site Not Available

  • The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Amicis Research Center - Anaheim

    Anaheim, California 92801
    United States

    Site Not Available

  • Ark Clinical-Fountain Valley

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Ark Clinical Research - Long Beach

    Long Beach, California 90806
    United States

    Site Not Available

  • Velocity Clinical Research - Los Angeles

    Los Angeles, California 90057
    United States

    Site Not Available

  • Infinity Clinical Research

    Norco, California 92860
    United States

    Site Not Available

  • Amicis Research Center

    Northridge, California 91324
    United States

    Site Not Available

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Orange County Research Center

    Tustin, California 92780
    United States

    Site Not Available

  • Amicis Research Center - West Hills

    West Hills, California 91307
    United States

    Site Not Available

  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Uptown Research Institute

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • The Center for Pharmaceutical Research

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Mercury Street Medical Group

    Butte, Montana 59701
    United States

    Site Not Available

  • Neurobehavioral Research, Inc. (NBR)

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Lucas Research, Inc

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Velocity Clinical Research - Cincinnati (New Horizons Clinical Research)

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Tribe Clinical Research

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Clinical Research Associates, Inc.

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas 78731
    United States

    Site Not Available

  • Apex Mobile Clinical Research

    Bellaire, Texas 77401
    United States

    Site Not Available

  • FutureSearch Trials of Dallas, LLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Velocity Clinical Research - Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Pinnacle Clinical Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Elevate Clinical

    Seabrook, Texas 77586
    United States

    Site Not Available

  • Impact Research Institute

    Waco, Texas 76710
    United States

    Site Not Available

  • Chrysalis Clinical Research

    St. George, Utah 84790
    United States

    Site Not Available

  • National Clinical Research - Richmond, Inc

    Richmond, Virginia 23294
    United States

    Site Not Available

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