CT-868 for Type 1 Diabetes

No longer recruiting at 45 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how CT-868, an experimental treatment, affects blood sugar control in adults with Type 1 Diabetes who are overweight or obese. Participants will receive either a low, medium, or high dose of CT-868, or a placebo (a harmless pill resembling the treatment), while maintaining their usual insulin routine. The goal is to determine if CT-868 improves blood sugar management compared to insulin alone. This trial suits adults who have had Type 1 Diabetes for at least a year, have a BMI over 27, and meet specific blood sugar criteria. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CT-868 is generally safe for humans. Studies have found that doses between 1.75 and 4.0 mg improve blood sugar levels without causing serious side effects. Most participants experienced only minor issues, if any, which were easy to manage.

One study found that CT-868 helps control blood sugar without significantly affecting glucagon, a hormone that increases blood sugar. This suggests the treatment can effectively help manage diabetes.

Since this trial is in Phase 2, it builds on earlier safety tests. CT-868 has already passed initial safety checks, but researchers continue to gather more information on how different doses work in people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Type 1 Diabetes, which often involve insulin therapy, CT-868 is an investigational drug that offers a novel approach. Researchers are excited because CT-868 is administered via a subcutaneous injection and targets specific pathways in the immune system, potentially offering a new mechanism of action. This could mean better management of the disease by addressing the underlying immune response rather than just managing blood sugar levels. Additionally, the different dosing options (low, medium, and high) are being explored to optimize effectiveness and minimize side effects, offering a more personalized treatment approach.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

Research has shown that CT-868 may help people with Type 1 Diabetes better control their blood sugar. In studies with diabetic mice, CT-868 not only aided in weight loss but also improved blood sugar levels compared to liraglutide or a placebo. In humans, doses of CT-868 between 1.75 and 4.0 mg resulted in significant reductions in HbA1c, a measure of long-term blood sugar levels. This trial will test various doses of CT-868, including low, medium, and high doses, alongside a placebo. These findings suggest that CT-868 could effectively lower blood sugar and manage diabetes. ^{1 2 3 5 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06062069

NCT06062069 | A Study of CT-868 in Type 1 Diabetes ... 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.

2. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70006

Efficacy and safety of CT‐868, a novel, fully biased, dual ... In diabetic mouse models, CT-868 decreased body weight compared with the GLP-1 receptor agonist liraglutide or placebo, and improved glycaemic ...

3. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/metabolic-disorder/t1d/a-study-of-ct-868-in-type-1-diabetes-mellitus-16185.html

A Study of CT-868 in Type 1 Diabetes Mellitus 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.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40762050/

Efficacy and safety of CT-868, a novel, fully biased, dual ... CT-868 1.75 to 4.0 mg yielded robust, clinically meaningful decreases in HbA1c, supporting potent glycaemic-lowering effects and improved ...

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.70006

Efficacy and safety of CT‐868, a novel, fully biased, dual ... Aims To assess the glycaemic efficacy and safety of CT-868, a cAMP signal-biased, dual glucagon-like peptide-1/glucose-dependent ...

6. diabetesjournals.org diabetesjournals.org/diabetes/article/72/Supplement_1/774-P/150287/774-P-Weight-Independent-Effects-of-CT-868-a

774-P: Weight-Independent Effects of CT-868, a Signaling ... This data supports a robust weight-independent effect of CT-868 (vs unbiased liraglutide) on glucose disposal with minimal suppression of glucagon.