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A Study of CT-868 in Type 1 Diabetes Mellitus

NCT06062069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Carmot Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Carmot Therapeutics, Inc., a member of the Roche Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2025-07-09
Completion
2025-07-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06062069 on ClinicalTrials.gov