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

December 20, 2024 updated by: Carmot Therapeutics, Inc.

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

This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Carmot Clinical Research Unit 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT-868
SC injection of CT-868 Intervention
Drug: CT-868
CT-868
Placebo Comparator: Placebo
SC injection of placebo matching CT-868 dose
Drug: Placebo
Placebo as SC Injection
Active Comparator: Victoza
SC injection of active comparator
Drug: Victoza
Victoza as active comparator as SC Injection
Other Names:
  • Liraglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess area under the curve (AUC) in glucose metabolism during MMTT
Time Frame: Baseline up to 4 days
Baseline up to 4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess changes in continuous glucose monitoring (CGM) measures
Time Frame: Baseline up to 4 days
Baseline up to 4 days
Area under the acetaminophen concentration-time (AUC)
Time Frame: 0 - 300 minutes
0 - 300 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmot Therapeutics, Inc.

Investigators

  • Study Director: Michael Elliott, Carmot Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Actual)

March 6, 2024

Study Completion (Actual)

April 6, 2024

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-868-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on CT-868

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe