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NCT05794581 Clinical Trial

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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05794581
Other study ID # CT-868-005
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 21, 2023
Est. completion date February 2024

Study information
Verified date March 2023
Source Carmot Therapeutics, Inc.
Contact Michael Elliott
Phone 510-666-6328
Email melliott@carmot.us
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date February 2024
Est. primary completion date February 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• CT-868
CT-868
• Placebo
Placebo as SC Injection
• Victoza
Victoza as active comparator as SC Injection

Locations
Country Name City State
United States Carmot Clinical Research Unit 101 Chula Vista California

Sponsors (1)
Lead Sponsor Collaborator
Carmot Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess area under the curve (AUC) in glucose metabolism during MMTT Baseline up to 4 days
Secondary To assess changes in continuous glucose monitoring (CGM) measures Baseline up to 4 days
Secondary Area under the acetaminophen concentration-time (AUC) 0 - 300 minutes
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