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A Study of CT-868 in Type 1 Diabetes Mellitus

Primary Purpose

Overweight, Obese, Type 1 Diabetes Mellitus

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CT-868
CT-868 Pen Injector
: CT-868 Pen Injector, Placebo
Sponsored by
Carmot Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, 18 years of age or older at the time of signing informed consent Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit Body mass index greater than or equal to27.0 kg/m2 Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit Exclusion Criteria: Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit

Sites / Locations

  • Carmot Therapeutic Investigational Site 106
  • Carmot Therapeutics Investigational Site 113
  • Carmot Therapeutics Investigational Site 112
  • Carmot Therapeutics Investigational Site 116
  • Carmot Therapeutics Investigational Site 104
  • Carmot Therapeutics Investigational Site 114
  • Carmot Therapeutics Investigational Site 107
  • Carmot Therapeutics Investigational Site 111
  • Carmot Therapeutics Investigational Site 110
  • Carmot Therapeutics Investigational Site 102
  • Carmot Therapeutics Investigational Site 101
  • Carmot Therapeutics Investigational Site 103
  • Carmot Therapeutics Investigational Site 105
  • Carmot Therapeutics Investigational Site 108
  • Carmot Therapeutics Investigational Site 115
  • Carmot Therapeutics Investigational Site 109

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CT-868 Low Dose

CT-868 Medium Dose

CT-868 High Dose

CT-868 Placebo

Arm Description

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks.

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks.

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks.

Participants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks.

Outcomes

Primary Outcome Measures

Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline

Secondary Outcome Measures

Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
To assess the percentage of participants achieving HbA1c of <7.0%.
To assess the percentage of participants achieving HbA1c of ≤6.5%.
To assess the percentage of participants achieving HbA1c of <5.7%.
Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.
Change in insulin doses from baseline when comparing CT-868 to placebo.

Full Information

First Posted
September 14, 2023
Last Updated
September 29, 2023
Sponsor
Carmot Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06062069
Brief Title
A Study of CT-868 in Type 1 Diabetes Mellitus
Official Title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 19, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carmot Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese, Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT-868 Low Dose
Arm Type
Experimental
Arm Description
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks.
Arm Title
CT-868 Medium Dose
Arm Type
Experimental
Arm Description
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks.
Arm Title
CT-868 High Dose
Arm Type
Experimental
Arm Description
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks.
Arm Title
CT-868 Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks.
Intervention Type
Drug
Intervention Name(s)
CT-868
Intervention Description
CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.
Intervention Type
Device
Intervention Name(s)
CT-868 Pen Injector
Intervention Description
The CT-868 pen injector is a multi-dose, single-participant, disposable pen.
Intervention Type
Drug
Intervention Name(s)
: CT-868 Pen Injector, Placebo
Intervention Description
The placebo pen injector is identical and contains the same ingredients except for CT-868.
Primary Outcome Measure Information:
Title
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
Time Frame
at Day 1 to Week 16
Secondary Outcome Measure Information:
Title
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
Time Frame
at Day 1 to Weeks 4, 8, and 12
Title
To assess the percentage of participants achieving HbA1c of <7.0%.
Time Frame
at Week 16
Title
To assess the percentage of participants achieving HbA1c of ≤6.5%.
Time Frame
at Week 16
Title
To assess the percentage of participants achieving HbA1c of <5.7%.
Time Frame
at Week 16
Title
Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.
Time Frame
at Day 1 to Week 16
Title
Change in insulin doses from baseline when comparing CT-868 to placebo.
Time Frame
at Day 1 to Weeks 8 and 16
Other Pre-specified Outcome Measures:
Title
Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics.
Time Frame
at Day 1 to Week 16
Title
Time in hypoglycemia as per CGM metrics.
Time Frame
at Day 1 to Week 16
Title
Time in hyperglycemia as per CGM metrics.
Time Frame
at Day 1 to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, 18 years of age or older at the time of signing informed consent Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit Body mass index greater than or equal to27.0 kg/m2 Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit Exclusion Criteria: Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Elliott
Phone
510-666-6328
Email
melliott@carmot.us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Elliott
Organizational Affiliation
Carmot Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Carmot Therapeutic Investigational Site 106
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 113
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 112
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 116
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 104
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 114
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 107
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 111
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 110
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 102
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 101
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 103
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 105
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 108
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 115
City
Weslaco
State/Province
Texas
ZIP/Postal Code
78596
Country
United States
Facility Name
Carmot Therapeutics Investigational Site 109
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://carmot.us/
Description
Related Info

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A Study of CT-868 in Type 1 Diabetes Mellitus

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