A Study of CT-868 in Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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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. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.

Official Title
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A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus

Conditions
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Overweight, Obese, Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: CT-868
* Device: CT-868 Pen Injector
* Drug: : CT-868 Pen Injector, Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Body mass index greater than or equal to27.0 kg/m2 Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit Exclusion Criteria: Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-868 Low Dose<br>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. | Drug: CT-868<br>* CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.<br>Device: CT-868 Pen Injector<br>* The CT-868 pen injector is a multi-dose, single-participant, disposable pen.<br>|
| Experimental: CT-868 Medium Dose<br>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. | Drug: CT-868<br>* CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.<br>Device: CT-868 Pen Injector<br>* The CT-868 pen injector is a multi-dose, single-participant, disposable pen.<br>|
| Experimental: CT-868 High Dose<br>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. | Drug: CT-868<br>* CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.<br>Device: CT-868 Pen Injector<br>* The CT-868 pen injector is a multi-dose, single-participant, disposable pen.<br>|
| Placebo Comparator: CT-868 Placebo<br>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. | Device: CT-868 Pen Injector<br>* The CT-868 pen injector is a multi-dose, single-participant, disposable pen.<br>Drug: : CT-868 Pen Injector, Placebo<br>* The placebo pen injector is identical and contains the same ingredients except for CT-868.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline |  | at Day 1 to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline |  | at Day 1 to Weeks 4, 8, and 12 | 
| To assess the percentage of participants achieving HbA1c of <7.0%. |  | at Week 16 | 
| To assess the percentage of participants achieving HbA1c of ≤6.5%. |  | at Week 16 | 
| To assess the percentage of participants achieving HbA1c of <5.7%. |  | at Week 16 | 
| Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo. |  | at Day 1 to Week 16 | 
| Change in insulin doses from baseline when comparing CT-868 to placebo. |  | at Day 1 to Weeks 8 and 16 |