Clinical trial NCT06525935: A Study of CT-388 in Participants With Obesity or 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight
Lead sponsor: Carmot Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2024-07-29
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Body Weight from Baseline to Week 48
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 48
timeFrame: Baseline and Week 48
measure: Absolute Change in Body Weight (kg) from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Percent Change in Body Weight from Baseline to Week 48 by Obesity Class
timeFrame: Baseline to Week 48
measure: Change in Body Mass Index (BMI) from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Waist Circumference from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Hip Circumference from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Waist-to-Hip Ratio from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Waist-to-Height Ratio from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Fasting Plasma Glucose from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Fasting Insulin from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Fasting C-peptide from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in Quantitative Insulin Sensitivity Check Index (QUICKI) from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Percentage of Participants with Shift in Glycemic Status from Baseline to Week 48, Based on Fasting Plasma Glucose and HbA1c
timeFrame: Baseline and Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Homewood
country: United States
facility: Central Alabama Research
state: Alabama
city: Mesa
country: United States
facility: The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health
state: Arizona
city: Anaheim
country: United States
facility: Amicis Research Center - Anaheim
state: California
city: Fountain Valley
country: United States
facility: Ark Clinical-Fountain Valley
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research - Long Beach
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research - Los Angeles
state: California
city: Norco
country: United States
facility: Infinity Clinical Research
state: California
city: Northridge
country: United States
facility: Amicis Research Center
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations Inc.
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: West Hills
country: United States
facility: Amicis Research Center - West Hills
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Louisville
country: United States
facility: Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
state: Kentucky
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc. (NBR)
state: New York
city: Morehead City
country: United States
facility: Lucas Research, Inc
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Cincinnati
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Greenville
country: United States
facility: Tribe Clinical Research
state: South Carolina
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Bellaire
country: United States
facility: Apex Mobile Clinical Research
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research - Dallas
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LLC
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Seabrook
country: United States
facility: Elevate Clinical
state: Texas
city: Waco
country: United States
facility: Impact Research Institute
state: Texas
city: St. George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc
state: Virginia
Study officials:
affiliation: Carmot Therapeutics, Inc., a Member of the Roche Group
name: Clinical Trials
role: STUDY_DIRECTOR
References: