Clinical trial NCT06628362: A Study of CT-388 in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
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 Subcutaneously for 48 Weeks to Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Overweight or Obese
Type 2 Diabetes Mellitus (T2DM)
Lead sponsor: Carmot Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2024-10-08
Enrollment: 360
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 who are overweight or obese with Type 2 diabetes mellitus (T2DM).


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 75 years of age
* Body mass index (BMI) ≥25.0 kg/m\^2
* Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) according to the World Health Organization classification or other locally applicable standards
* Have an HbA1c ≥7% and ≤10.5%
* Management of T2DM with diet and exercise alone, metformin, or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, as monotherapy or in combination, per approved local label
* At least one self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

* Have Type 1 Diabetes Mellitus (T1DM), history of ketosis or hyperosmolar state/coma, or any other types of diabetes except T2DM
* Have had 1 or more episodes of Level 3 hypoglycemia or have had hypoglycemia unawareness within 3 months prior to screening
* Have history or presence of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment
* Have evidence of clinically significant autonomic neuropathy (symptoms may include resting tachycardia, orthostatic hypotension, or diabetic diarrhea)
* Had treatment with any oral antihyperglycemic medications, with the exception of metformin or SGLT-2 inhibitors, within 3 months prior to screening or planned concurrent treatment with these medications during the study
* Had treatment with injectable antihyperglycemic medication, with the exception of short-term insulin, within 6 months prior to screening or planned concurrent treatment with these medications during the study
* Self-reported body weight change of \>5 kg within 3 months before screening
* Any unbalanced/extreme diets, such as very low calorie, low carbohydrate, very high protein, ketogenic, or intermittent diets, within 3 months of the screening visit, or plan to be on such diets during the study
* 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 or procedure for obesity, except for liposuction or abdominoplasty if performed \>1 year prior to screening. Participants with a history of devices, such as LAP-BAND® or intragastric balloon, are permitted, if devices were removed \>1 year prior to screening.
* History of clinically significant or active gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction, intestinal obstruction), or chronic use of medications that directly affect GI motility
* History of chronic pancreatitis or acute pancreatitis or have signs and symptoms of acute pancreatitis at screening
* Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity
* History or diagnosis of significant active or unstable major depressive disorder or any history/diagnosis of other severe psychiatric conditions (e.g., schizophrenia; bipolar disorder; other serious mood disorder or anxiety disorder, or hyperactivity disorder) within the last year before screening
* History of any hematologic conditions that may interfere with HbA1c measurement (e.g., hemolytic anemias, sickle cell disease, other hemoglobinopathies)
* Family or personal history of medullary thyroid carcinoma
* Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method as required per protocol

Primary outcomes:
measure: Percent Change in Body Weight from Baseline to Week 36
timeFrame: Baseline to Week 36
measure: Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Percent Change in Body Weight from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Change in HbA1c from Baseline to Week 48
timeFrame: Baseline to Week 48
measure: Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48
timeFrame: Weeks 36 and 48
measure: Percentage of Participants with Body Weight Reduction ≥5%, ≥10%, ≥15%, ≥20%, and ≥25% from Baseline to Week 36
timeFrame: Baseline and Week 36
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: Percent Change in Body Weight from Baseline to Week 28
timeFrame: Baseline and Week 28
measure: Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48
timeFrame: Baseline to Weeks 36 and 48
measure: Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
timeFrame: Baseline to Weeks 16, 28, 36, and 48
measure: Change in HbA1c from Baseline to Weeks 16 and 28
timeFrame: Baseline to Weeks 16 and 28
measure: Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
timeFrame: Baseline to Weeks 16, 28, 36, and 48
measure: Percentage of Participants with HbA1c ≤6.5% at Weeks 16, 28, 36, and 48
timeFrame: Weeks 16, 28, 36, and 48
measure: Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48
timeFrame: Weeks 16, 28, 36, and 48
measure: Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48
timeFrame: Weeks 16, 28, 36, and 48
measure: Percentage of Participants who Achieve HbA1c ≤6.5% and ≥10.0% Weight Reduction at Weeks 16, 28, 36, and 48
timeFrame: Baseline, Weeks 16, 28, 36, and 48
measure: Percentage of Participants who Achieve HbA1c <7.0% and ≥5.0% Weight Reduction at Weeks 16, 28, 36, and 48
timeFrame: Baseline, Weeks 16, 28, 36, and 48
measure: Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48
timeFrame: Baseline, Weeks 36 and 48
measure: Change in Waist Circumference from Baseline to Weeks 36 and 48
timeFrame: Baseline, Weeks 36 and 48
measure: Change in Hip Circumference from Baseline to Weeks 36 and 48
timeFrame: Baseline, Weeks 36 and 48
measure: Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48
timeFrame: Baseline, Weeks 36 and 48
measure: Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48
timeFrame: Baseline, Weeks 36 and 48
measure: Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48
timeFrame: Baseline to Weeks 16, 28, 36, and 48
measure: Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48
timeFrame: Baseline to Weeks 16, 28, 36, and 48
measure: Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48
timeFrame: Baseline to Weeks 16, 28, 36, and 48
measure: Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48
timeFrame: Baseline to Weeks 16, 28, 36, and 48
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, Llc; Central
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research, LLC
state: Alabama
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Lake Forest
country: United States
facility: Orange Country Research Center
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Sherman Oaks
country: United States
facility: Asclepes Research Centers
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials, LLC
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Lutz
country: United States
facility: ASCLEPES Research Centers
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research, LLC - Maitland
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research, LLC - Orlando
state: Florida
city: Miami
country: United States
facility: Flourish Research Acquisition, LLC
state: Florida
city: Orlando
country: United States
facility: K2 Medical Research, LLC - South Orlando
state: Florida
city: Tampa
country: United States
facility: K2 Medical Research Tampa
state: Florida
city: The Villages
country: United States
facility: K2 Summit Research
state: Florida
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Lombard
country: United States
facility: Accellacare of Duly Health and Care
state: Illinois
city: Ames
country: United States
facility: McFarland Clinic
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Metairie
country: United States
facility: NOLA Cares, LLC
state: Louisiana
city: Bowie
country: United States
facility: Flourish Research Acquisition, LLC dba Flourish Bowie
state: Maryland
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research LLC
state: Massachusetts
city: Flint
country: United States
facility: Ahmed Arif Medical Research Center (AA MRC LLC)
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center; Family Medicine
state: Mississippi
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG
state: Mississippi
city: Brooklyn
country: United States
facility: Ellipsis Research Group
state: New York
city: Cary
country: United States
facility: Accellacare of Cary
state: North Carolina
city: Hickory
country: United States
facility: Accellacare - Hickory
state: North Carolina
city: Rocky Mount
country: United States
facility: Accellacare of Rocky Mount
state: North Carolina
city: Statesville
country: United States
facility: Accellacare of Piedmont Healthcare
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare of Wilmington, LLC
state: North Carolina
city: Winston Salem
country: United States
facility: Accellacare Research of Winston Salem
state: North Carolina
city: Canton
country: United States
facility: Diabetes and Endocrinology Associates of Stark County, Inc.
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC (AMR Norman)
state: Oklahoma
city: Mount Pleasant
country: United States
facility: Roper St. Francis Physician Partners - Primary Care
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatrics Associates of Bristol; PMG Research of Bristol
state: Tennessee
city: Jefferson
country: United States
facility: Accellacare - Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: Norwood Family Medicine
state: Tennessee
city: Knoxville
country: United States
facility: Summit-Halls Family Practice
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research - Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center Investigation Drug Services
state: Texas
city: Houston
country: United States
facility: Juno Research, LLC
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research
state: Texas
city: Cuauhtemoc
country: Mexico
facility: CEMDEC S.A. de C.V.
city: Cuernavaca
country: Mexico
facility: Instituto de Diabetes Obesidad y Nutricion, SC
city: Culiacan
country: Mexico
facility: SINACOR
city: Merida
country: Mexico
facility: Medical Care and Research S.A de C.V
city: Mexicali
country: Mexico
facility: Centro De Investigacion En Artritis Y Osteopososis
city: Mexico City
country: Mexico
facility: Clinicos Asociados Bocm, S.C.
city: San Pedro Garza García
country: Mexico
facility: Avant Santé Research Center
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C.
Study officials:
affiliation: Carmot Therapeutics, Inc., a Member of the Roche Group
name: Clinical Trials
role: STUDY_DIRECTOR
References: