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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06628362




Registration number
NCT06628362
Ethics application status
Date submitted
3/10/2024
Date registered
8/10/2024
Date last updated
22/08/2025

Titles & IDs
Public title
A Study of CT-388 in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
Scientific 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
Secondary ID [1] 0 0
XC45544
Secondary ID [2] 0 0
CT-388-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight or Obese 0 0
Type 2 Diabetes Mellitus (T2DM) 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - CT-388

Placebo comparator: Arm 1: Placebo -

Experimental: Arm 2: CT-388 Dose Level 1 (Low) -

Experimental: Arm 3: CT-388 Dose Level 2 -

Experimental: Arm 4: CT-388 Dose Level 3 -

Experimental: Arm 5: CT-388 Dose Level 4 (High) -


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

Treatment: Drugs: CT-388
CT-388 will be administered subcutaneously (SC) once weekly at the randomized dosing regimen.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change in Body Weight from Baseline to Week 36
Timepoint [1] 0 0
Baseline to Week 36
Primary outcome [2] 0 0
Change in Glycated Hemoglobin (HbA1c) from Baseline to Week 36
Timepoint [2] 0 0
Baseline to Week 36
Secondary outcome [1] 0 0
Percent Change in Body Weight from Baseline to Week 48
Timepoint [1] 0 0
Baseline to Week 48
Secondary outcome [2] 0 0
Change in HbA1c from Baseline to Week 48
Timepoint [2] 0 0
Baseline to Week 48
Secondary outcome [3] 0 0
Percentage of Participants with HbA1c <7.0% at Weeks 36 and 48
Timepoint [3] 0 0
Weeks 36 and 48
Secondary outcome [4] 0 0
Percentage of Participants with Body Weight Reduction =5%, =10%, =15%, =20%, and =25% from Baseline to Week 36
Timepoint [4] 0 0
Baseline and Week 36
Secondary outcome [5] 0 0
Percentage of Participants with Body Weight Reduction =5%, =10%, =15%, =20%, and =25% from Baseline to Week 48
Timepoint [5] 0 0
Baseline and Week 48
Secondary outcome [6] 0 0
Percent Change in Body Weight from Baseline to Week 28
Timepoint [6] 0 0
Baseline and Week 28
Secondary outcome [7] 0 0
Absolute Change in Body Weight (kg) from Baseline to Weeks 36 and 48
Timepoint [7] 0 0
Baseline to Weeks 36 and 48
Secondary outcome [8] 0 0
Percent Change in Body Weight from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Timepoint [8] 0 0
Baseline to Weeks 16, 28, 36, and 48
Secondary outcome [9] 0 0
Change in HbA1c from Baseline to Weeks 16 and 28
Timepoint [9] 0 0
Baseline to Weeks 16 and 28
Secondary outcome [10] 0 0
Change in HbA1c from Baseline to Weeks 16, 28, 36, and 48 by Obesity Class
Timepoint [10] 0 0
Baseline to Weeks 16, 28, 36, and 48
Secondary outcome [11] 0 0
Percentage of Participants with HbA1c =6.5% at Weeks 16, 28, 36, and 48
Timepoint [11] 0 0
Weeks 16, 28, 36, and 48
Secondary outcome [12] 0 0
Percentage of Participants with HbA1c <5.7% at Weeks 16, 28, 36, and 48
Timepoint [12] 0 0
Weeks 16, 28, 36, and 48
Secondary outcome [13] 0 0
Change in 7-point Self-Monitored Blood Glucose (SMBG) Profile at Weeks 16, 28, 36, and 48
Timepoint [13] 0 0
Weeks 16, 28, 36, and 48
Secondary outcome [14] 0 0
Percentage of Participants who Achieve HbA1c =6.5% and =10.0% Weight Reduction at Weeks 16, 28, 36, and 48
Timepoint [14] 0 0
Baseline, Weeks 16, 28, 36, and 48
Secondary outcome [15] 0 0
Percentage of Participants who Achieve HbA1c <7.0% and =5.0% Weight Reduction at Weeks 16, 28, 36, and 48
Timepoint [15] 0 0
Baseline, Weeks 16, 28, 36, and 48
Secondary outcome [16] 0 0
Change in Body Mass Index (BMI) from Baseline to Weeks 36 and 48
Timepoint [16] 0 0
Baseline, Weeks 36 and 48
Secondary outcome [17] 0 0
Change in Waist Circumference from Baseline to Weeks 36 and 48
Timepoint [17] 0 0
Baseline, Weeks 36 and 48
Secondary outcome [18] 0 0
Change in Hip Circumference from Baseline to Weeks 36 and 48
Timepoint [18] 0 0
Baseline, Weeks 36 and 48
Secondary outcome [19] 0 0
Change in Waist-to-Hip Ratio from Baseline to Weeks 36 and 48
Timepoint [19] 0 0
Baseline, Weeks 36 and 48
Secondary outcome [20] 0 0
Change in Waist-to-Height Ratio from Baseline to Weeks 36 and 48
Timepoint [20] 0 0
Baseline, Weeks 36 and 48
Secondary outcome [21] 0 0
Change in Fasting Plasma Glucose from Baseline to Weeks 16, 28, 36, and 48
Timepoint [21] 0 0
Baseline to Weeks 16, 28, 36, and 48
Secondary outcome [22] 0 0
Change in Fasting Insulin from Baseline to Weeks 16, 28, 36, and 48
Timepoint [22] 0 0
Baseline to Weeks 16, 28, 36, and 48
Secondary outcome [23] 0 0
Change in Fasting C-peptide from Baseline to Weeks 16, 28, 36, and 48
Timepoint [23] 0 0
Baseline to Weeks 16, 28, 36, and 48
Secondary outcome [24] 0 0
Change in Fasting Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) from Baseline to Weeks 16, 28, 36, and 48
Timepoint [24] 0 0
Baseline to Weeks 16, 28, 36, and 48

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
Argentina
State/province [23] 0 0
Provincia de Buenos
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Mexico
State/province [25] 0 0
Cuauhtémoc
Country [26] 0 0
Mexico
State/province [26] 0 0
Cuernavaca
Country [27] 0 0
Mexico
State/province [27] 0 0
Culiacán
Country [28] 0 0
Mexico
State/province [28] 0 0
Mexicali
Country [29] 0 0
Mexico
State/province [29] 0 0
Mexico City
Country [30] 0 0
Mexico
State/province [30] 0 0
Mérida
Country [31] 0 0
Mexico
State/province [31] 0 0
San Pedro Garza García
Country [32] 0 0
Mexico
State/province [32] 0 0
Veracruz
Country [33] 0 0
New Zealand
State/province [33] 0 0
Auckland
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
New Zealand
State/province [35] 0 0
Grafton
Country [36] 0 0
New Zealand
State/province [36] 0 0
Tauranga
Country [37] 0 0
New Zealand
State/province [37] 0 0
Wellington
Country [38] 0 0
Puerto Rico
State/province [38] 0 0
Guaynabo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Carmot Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Carmot Therapeutics, Inc., a Member of the Roche Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID: CT-388-104 Roche Study ID: XC45544
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06628362