Clinical trial NCT06062069: A Study of CT-868 in Type 1 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Overweight
Obese
Type 1 Diabetes Mellitus
Lead sponsor: Carmot Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
timeFrame: at Day 1 to Week 16
Secondary outcomes:
measure: Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
timeFrame: at Day 1 to Weeks 4, 8, and 12
measure: To assess the percentage of participants achieving HbA1c of <7.0%.
timeFrame: at Week 16
measure: To assess the percentage of participants achieving HbA1c of ≤6.5%.
timeFrame: at Week 16
measure: To assess the percentage of participants achieving HbA1c of <5.7%.
timeFrame: at Week 16
measure: Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.
timeFrame: at Day 1 to Week 16
measure: Change in insulin doses from baseline when comparing CT-868 to placebo.
timeFrame: at Day 1 to Weeks 8 and 16
Other outcomes:
measure: Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics.
timeFrame: at Day 1 to Week 16
measure: Time in hypoglycemia as per CGM metrics.
timeFrame: at Day 1 to Week 16
measure: Time in hyperglycemia as per CGM metrics.
timeFrame: at Day 1 to Week 16
Locations:
city: Concord
country: United States
facility: Carmot Therapeutics Investigational Site 121
state: California
city: Escondido
country: United States
facility: Carmot Therapeutics Investigational Site 125
state: California
city: Aurora
country: United States
facility: Carmot Therapeutics Investigational Site 118
state: Colorado
city: Englewood
country: United States
facility: Carmot Therapeutics Investigational Site 119
state: Colorado
city: Orlando
country: United States
facility: Carmot Therapeutics Investigational Site 113
state: Florida
city: Orlando
country: United States
facility: Carmot Therapeutics Investigational Site 112
state: Florida
city: Port Charlotte
country: United States
facility: Carmot Therapeutics Investigational Site 116
state: Florida
city: Atlanta
country: United States
facility: Carmot Therapeutics Investigational Site 123
state: Georgia
city: Idaho Falls
country: United States
facility: Carmot Therapeutics Investigational Site 126
state: Idaho
city: West Des Moines
country: United States
facility: Carmot Therapeutics Investigational Site 104
state: Iowa
city: Hyattsville
country: United States
facility: Carmot Therapeutics Investigational Site 114
state: Maryland
city: Asheville
country: United States
facility: Carmot Therapeutics Investigational Site 111
state: North Carolina
city: Chapel Hill
country: United States
facility: Carmot Therapeutics Investigational Site 110
state: North Carolina
city: Morehead City
country: United States
facility: Carmot Therapeutics Investigational Site 102
state: North Carolina
city: Portland
country: United States
facility: Carmot Therapeutics Investigational Site 122
state: Oregon
city: Austin
country: United States
facility: Carmot Therapeutics Investigational Site 101
state: Texas
city: Dallas
country: United States
facility: Carmot Therapeutics Investigational Site 103
state: Texas
city: Dallas
country: United States
facility: Carmot Therapeutics Investigational Site 105
state: Texas
city: San Antonio
country: United States
facility: Carmot Therapeutics Investigational Site 124
state: Texas
city: Shavano Park
country: United States
facility: Carmot Therapeutics Investigational Site 108
state: Texas
city: Weslaco
country: United States
facility: Carmot Therapeutics Investigational Site 115
state: Texas
city: Renton
country: United States
facility: Carmot Therapeutics Investigational Site 109
state: Washington
Study officials:
affiliation: Carmot Therapeutics, Inc., a member of the Roche Group
name: Clinical Trials
role: STUDY_DIRECTOR
References: