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CT-868 for Type 1 Diabetes

Phase 2

Recruiting

Research Sponsored by Carmot Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, 18 years of age or older at the time of signing informed consent

Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 1 to weeks 4, 8, and 12

Awards & highlights

Study Summary

This trial will evaluate how effective and safe CT-868 is in improving glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus, with guidance on managing their diabetes.

Who is the study for?

Adults over 18 with Type 1 Diabetes Mellitus (T1DM) for at least a year, an HbA1c level of 7.0% to 10.0%, and a BMI of 27 kg/m2 or more can join this study. It's not for those who've had severe hypoglycemia or diabetic ketoacidosis in the last three months, or anyone diagnosed with Type 2 diabetes.Check my eligibility

What is being tested?

The trial is testing CT-868 delivered via pen injector against a placebo in overweight adults with T1DM while they continue their usual insulin treatments. Over the course of 16 weeks, participants will also receive lifestyle guidance alongside their randomly assigned treatment.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions typical to diabetes medications such as low blood sugar levels, injection site reactions, and possible weight changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with Type 1 Diabetes for at least a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 1 to weeks 4, 8, and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 1 to weeks 4, 8, and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 to weeks 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.

Change in insulin doses from baseline when comparing CT-868 to placebo.

Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline

+3 more

Other outcome measures

Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics.

Time in hyperglycemia as per CGM metrics.

Time in hypoglycemia as per CGM metrics.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: CT-868 Medium DoseExperimental Treatment2 Interventions

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks.

Group II: CT-868 Low DoseExperimental Treatment2 Interventions

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks.

Group III: CT-868 High DoseExperimental Treatment2 Interventions

Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks.

Group IV: CT-868 PlaceboPlacebo Group2 Interventions

Participants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carmot Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

366 Total Patients Enrolled

Michael ElliottStudy DirectorCarmot Therapeutics

5 Previous Clinical Trials

366 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks do individuals using CT-868 Low Dose generally encounter?

"Our team at Power assessed the safety of CT-868 Low Dose to be a 2, considering it is in its second clinical trial phase. This suggests that although there has been no evidence yet for efficacy, safety measures have already been established."

Answered by AI

At how many venues is this research endeavor taking place?

"This trial is being administered at 16 distinct medical centres. Among them are Carmot Therapeutics Investigational Site 113 in Orlando, Carmot Therapeutics Investigational Site 112 in Port Charlotte, and Carmot Therapeutics Investigational Site 116 in West Des Moines as well as another 13 sites."

Answered by AI

Are there still places available for individuals to join this research trial?

"The clinicaltrials.gov repository shows that this particular trial, initially posted on October 19th 2023 and last modified September 29th 2023, is not currently recruiting patients. Despite this development, there are numerous other studies seeking participants at the moment - 1606 to be exact."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of CT-868 in Type 1 Diabetes Mellitus

2023. "A Study of CT-868 in Type 1 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06062069.

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