CT-868 for Type 1 Diabetes

Recruiting at 23 trial locations

Overseen By Alexandra Steinberg

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Carmot Therapeutics, Inc.

Must be taking: Insulin

Disqualifiers: Type 2 diabetes, DKA, severe hypoglycemia

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

111 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you will continue with your standard diabetes care using either an insulin pump or multiple daily injections.

What safety data exists for CT-868 in humans?

The safety of anti-CD3 monoclonal antibodies, which may include CT-868, has been studied in type 1 diabetes. Some studies have shown that while these treatments can help preserve beta cell function, finding the right dose with acceptable safety and tolerability has been challenging. There have been concerns about long-term safety risks with immune suppressive agents, but more research is needed to balance safety and effectiveness. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new treatment called CT-868 to see if it helps overweight and obese adults with Type 1 Diabetes control their blood sugar better. Participants will continue their regular insulin therapy and receive either CT-868 or another treatment. The goal is to find out if CT-868 can make blood sugar levels more stable.

Research Team

Clinical Trials

Principal Investigator

Carmot Therapeutics, Inc., a member of the Roche Group

Eligibility Criteria

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.

Inclusion Criteria

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

You have a body mass index (BMI) of 27 or higher.

Your HbA1c level is between 7.0% and 10.0%.

Exclusion Criteria

I had diabetic ketoacidosis within the last 3 months.

I have been diagnosed with Type 2 diabetes or another type, but not Type 1.

I have had a severe low blood sugar episode in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CT-868 or placebo in a subcutaneous injection form once daily for 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CT-868

Trial Overview 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.

Participant Groups

Group I: CT-868 Medium Dose Experimental Treatment 2 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 Dose Experimental Treatment 2 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 Dose Experimental Treatment 2 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 Placebo Placebo Group 2 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.

Who Is Running the Clinical Trial?

Carmot Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

1,300+

Findings from Research

Current treatments for Type 1 diabetes (T1D), like cyclosporin, show that it is possible to prevent the disease, but they come with significant long-term safety risks.

The concept of antigen-specific tolerization is proposed as a safer strategy to achieve long-term protection against T1D, emphasizing the need for careful trial design to balance safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trials in type 1 diabetes: Antigen-specific therapies. Coppieters, KT., Harrison, LC., von Herrath, MG.[2021]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

Therapies aimed at preservation or restoration of beta cell function in type 1 diabetes. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Anti-CD3 monoclonal antibodies in treatment of type 1 diabetes: a systematic review and meta-analysis. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

A randomised, single-blind, placebo-controlled, dose-finding safety and tolerability study of the anti-CD3 monoclonal antibody otelixizumab in new-onset type 1 diabetes. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Trials in type 1 diabetes: Antigen-specific therapies. [2021]