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A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CT-868
Placebo
Victoza
Sponsored by
Carmot Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Obesity, Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Female or male adults with Type 1 diabetes Ages 18-65 years Type 1 DM for at least 3 years Using an insulin pump or multiple daily injections (MDI) for at least 3 months BMI 25.0 - 35.0 Exclusion Criteria: Significant medical history Uncontrolled diabetes History of surgical treatment for weight loss History of malignancy

Sites / Locations

  • Carmot Clinical Research Unit 101Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

CT-868

Placebo

Victoza

Arm Description

SC injection of CT-868 Intervention

SC injection of placebo matching CT-868 dose

SC injection of active comparator

Outcomes

Primary Outcome Measures

To assess area under the curve (AUC) in glucose metabolism during MMTT

Secondary Outcome Measures

To assess changes in continuous glucose monitoring (CGM) measures
Area under the acetaminophen concentration-time (AUC)

Full Information

First Posted
March 10, 2023
Last Updated
June 21, 2023
Sponsor
Carmot Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05794581
Brief Title
A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes
Official Title
A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 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 be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT-868
Arm Type
Experimental
Arm Description
SC injection of CT-868 Intervention
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
SC injection of placebo matching CT-868 dose
Arm Title
Victoza
Arm Type
Active Comparator
Arm Description
SC injection of active comparator
Intervention Type
Drug
Intervention Name(s)
CT-868
Intervention Description
CT-868
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo as SC Injection
Intervention Type
Drug
Intervention Name(s)
Victoza
Other Intervention Name(s)
Liraglutide
Intervention Description
Victoza as active comparator as SC Injection
Primary Outcome Measure Information:
Title
To assess area under the curve (AUC) in glucose metabolism during MMTT
Time Frame
Baseline up to 4 days
Secondary Outcome Measure Information:
Title
To assess changes in continuous glucose monitoring (CGM) measures
Time Frame
Baseline up to 4 days
Title
Area under the acetaminophen concentration-time (AUC)
Time Frame
0 - 300 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female or male adults with Type 1 diabetes Ages 18-65 years Type 1 DM for at least 3 years Using an insulin pump or multiple daily injections (MDI) for at least 3 months BMI 25.0 - 35.0 Exclusion Criteria: Significant medical history Uncontrolled diabetes History of surgical treatment for weight loss History of malignancy
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, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Carmot Clinical Research Unit 101
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://carmot-therapeutics.us/
Description
Carmot Therapeutics, Inc.

Learn more about this trial

A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes

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