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

Sponsor
Carmot Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05794581
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
9
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess area under the curve (AUC) in glucose metabolism during MMTT [Baseline up to 4 days]

    Secondary Outcome Measures

    1. To assess changes in continuous glucose monitoring (CGM) measures [Baseline up to 4 days]

    2. Area under the acetaminophen concentration-time (AUC) [0 - 300 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Carmot Clinical Research Unit 101 Chula Vista California United States 91911

    Sponsors and Collaborators

    • Carmot Therapeutics, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Carmot Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT05794581
    Other Study ID Numbers:
    • CT-868-005
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 3, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Carmot Therapeutics, Inc.
    Type 1 Diabetes
    Obesity
    Overweight
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    Liraglutide

    Study Results

    No Results Posted as of Apr 3, 2023