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NCT06525935

PHASE2

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

Sponsor: Carmot Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants with obesity or who are overweight with at least one weight-related comorbidity.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Weekly CT-388 Administered for 48 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

469

Start Date

2024-08-16

Completion Date

2025-12-08

Last Updated

2026-10-05

Healthy Volunteers

Conditions

Obesity Overweight

Interventions

DRUG

Placebo

Placebo will be volume- matched and administered subcutaneously (SC) once weekly.

DRUG

Enicepatide

Enicepatide will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.

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 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, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course 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 of childbearing potential and not using a highly effective contraceptive method

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (34)