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COMPLETED
NCT06062069
PHASE2

A Study of CT-868 in Type 1 Diabetes Mellitus

Sponsor: Carmot Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.

Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2023-11-27

Completion Date

2025-07-07

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

CT-868

CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.

DEVICE

CT-868 Pen Injector

The CT-868 pen injector is a multi-dose, single-participant, disposable pen.

DRUG

CT-868 Pen Injector, Placebo

The placebo pen injector is identical and contains the same ingredients except for CT-868.

Locations (22)

John Muir Physician Network Clinical Research Center

Concord, California, United States

Headlands Research- AMCR

Escondido, California, United States

University of Colorado - Barbara Davis Center for Diabetes

Aurora, Colorado, United States

Denver Endocrinology Diabetes and Thyroid Center

Englewood, Colorado, United States

Advent Health

Orlando, Florida, United States

Orlando Health Science Clinic, LLC

Orlando, Florida, United States

Innovative Research Institute

Port Charlotte, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho

Idaho Falls, Idaho, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

MedStar Health Research Institute - Washington Hospital Center

Hyattsville, Maryland, United States

University of North Carolina Health Sciences at MAHEC

Asheville, North Carolina, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Lucas Research, Inc

Morehead City, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

Texas Diabetes and Endocrinology, P.A

Austin, Texas, United States

Velocity Clinical Research - Dallas

Dallas, Texas, United States

Research Institute of Dallas

Dallas, Texas, United States

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, United States

Consano Clinical Research

Shavano Park, Texas, United States

Texas Valley Clinical Research, LLC

Weslaco, Texas, United States

Rainier Clinical Research Center

Renton, Washington, United States