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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT06525935

Run by

Carmot Therapeutics, Inc.

People needed

469

Starts

2024-08-16

Expected to finish

2025-12-08

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.