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

Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Victoza; Drug: CT-868; Drug: Placebo

• Registration Number: NCT05794581
• Lead Sponsor: Carmot Therapeutics, Inc.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-03-10
• Study Start: 2023-03-21
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-03
• Primary Completion: 2024-03-06
• Study Completion: 2024-04-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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Exclusion Criteria

• Significant medical history
• Uncontrolled diabetes
• History of surgical treatment for weight loss
• History of malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Victoza	Victoza	SC injection of active comparator
CT-868	CT-868	SC injection of CT-868 Intervention
Placebo	Placebo	SC injection of placebo matching CT-868 dose

Primary Outcome Measures

Name	Time	Method
To assess area under the curve (AUC) in glucose metabolism during MMTT	Baseline up to 4 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Carmot Clinical Research Unit 101; 🇺🇸 Chula Vista, California, United States