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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
Must not have
Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM
Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 1 to weeks 4, 8, and 12
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Type 2 diabetes or another type, but not Type 1.
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I have had a severe low blood sugar episode in the last 3 months.

Timeline

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity that improve glycemic control often work by targeting glucose metabolism and insulin sensitivity. GLP-1 receptor agonists, for example, enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps reduce blood glucose levels and promote weight loss. SGLT2 inhibitors reduce glucose reabsorption in the kidneys, leading to increased glucose excretion in urine and improved glycemic control. These mechanisms are crucial for obesity patients as they not only aid in weight loss but also help manage and prevent comorbid conditions like type 2 diabetes, thereby improving overall health outcomes.
Pharmacotherapy of obesity.

Find a Location

Who is running the clinical trial?

Carmot Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
366 Total Patients Enrolled
1 Trials studying Obesity
96 Patients Enrolled for Obesity
Michael ElliottStudy DirectorCarmot Therapeutics
5 Previous Clinical Trials
366 Total Patients Enrolled
1 Trials studying Obesity
96 Patients Enrolled for Obesity
~24 spots leftby Oct 2024