A Study of CT-868 in Type 1 Diabetes Mellitus

• Sponsor: Carmot Therapeutics, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06062069
• Collaborator: (none)
• Enrollment: 96
• Locations: 16
• Arms: 4
• Anticipated Duration (Months): 12.4
• Patients Per Site: 6
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obese; Type 1 Diabetes Mellitus	Drug: CT-868; Device: CT-868 Pen Injector; Drug: : CT-868 Pen Injector, Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Oct 19, 2023
• Anticipated Primary Completion Date: Oct 31, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline [at Day 1 to Week 16]

Secondary Outcome Measures

1. Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline [at Day 1 to Weeks 4, 8, and 12]

2. To assess the percentage of participants achieving HbA1c of <7.0%. [at Week 16]

3. To assess the percentage of participants achieving HbA1c of ≤6.5%. [at Week 16]

4. To assess the percentage of participants achieving HbA1c of <5.7%. [at Week 16]

5. Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo. [at Day 1 to Week 16]

6. Change in insulin doses from baseline when comparing CT-868 to placebo. [at Day 1 to Weeks 8 and 16]

Other Outcome Measures

1. Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics. [at Day 1 to Week 16]

2. Time in hypoglycemia as per CGM metrics. [at Day 1 to Week 16]

3. Time in hyperglycemia as per CGM metrics. [at Day 1 to Week 16]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carmot Therapeutic Investigational Site 106	La Jolla	California	United States	92037
2	Carmot Therapeutics Investigational Site 113	Orlando	Florida	United States	32804
3	Carmot Therapeutics Investigational Site 112	Orlando	Florida	United States	32822
4	Carmot Therapeutics Investigational Site 116	Port Charlotte	Florida	United States	33952
5	Carmot Therapeutics Investigational Site 104	West Des Moines	Iowa	United States	50265
6	Carmot Therapeutics Investigational Site 114	Hyattsville	Maryland	United States	20782
7	Carmot Therapeutics Investigational Site 107	Detroit	Michigan	United States	48202
8	Carmot Therapeutics Investigational Site 111	Asheville	North Carolina	United States	28803
9	Carmot Therapeutics Investigational Site 110	Chapel Hill	North Carolina	United States	27517
10	Carmot Therapeutics Investigational Site 102	Morehead City	North Carolina	United States	28557
11	Carmot Therapeutics Investigational Site 101	Austin	Texas	United States	78731
12	Carmot Therapeutics Investigational Site 103	Dallas	Texas	United States	75230
13	Carmot Therapeutics Investigational Site 105	Dallas	Texas	United States	75231
14	Carmot Therapeutics Investigational Site 108	Shavano Park	Texas	United States	78231
15	Carmot Therapeutics Investigational Site 115	Weslaco	Texas	United States	78596
16	Carmot Therapeutics Investigational Site 109	Renton	Washington	United States	98057

Sponsors and Collaborators

• Carmot Therapeutics, Inc.

Investigators

• Study Director: Michael Elliott, Carmot Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Carmot Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT06062069
• Other Study ID Numbers: CT-868-004
• First Posted: Oct 2, 2023
• Last Update Posted: Oct 2, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Overweight

Study Results

No Results Posted as of Oct 2, 2023