What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for obesity that improve glycemic control, such as GLP-1 receptor agonists, SGLT2 inhibitors, and metformin, have specific side effects. GLP-1 receptor agonists can cause gastrointestinal issues like nausea, vomiting, and diarrhea, and have been associated with pancreatitis. SGLT2 inhibitors may lead to urinary tract infections, genital infections, and dehydration. Metformin is known for gastrointestinal side effects, including diarrhea, nausea, and abdominal discomfort. These treatments are generally well-tolerated but require monitoring for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity that also improve glycemic control. Notably, GLP-1 receptor agonists such as liraglutide (Saxenda) and semaglutide (Wegovy) have been approved for weight management in addition to their use in diabetes treatment. These drugs work by enhancing insulin secretion, reducing glucagon levels, and slowing gastric emptying, which collectively improve glycemic control and promote weight loss. These mechanisms are similar to those being studied in the trial of CT-868, which aims to improve glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus.

What other types of research exist?

Promising novel alternatives to CT-868 for obesity patients include: 1) AC163794, a long-acting glucose-dependent insulinotropic peptide analogue, which has shown enhanced efficacy and longer duration of insulinotropic action in diabetic rodents. 2) NN9056, a long-acting CCK analogue, which has demonstrated significant effects on reducing food intake and body weight in obese minipigs. 3) YH18968, a G-protein coupled receptor 119 agonist, which has improved glucose tolerance in diet-induced obese mice and may be effective when combined with a DPP-4 inhibitor.

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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 up to 5 years

Summary

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.

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.

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.

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.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 / 4Eligibility criteria met

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.