A Study of CT-868 in Type 1 Diabetes Mellitus

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06062069

Enrollment

111

Registered

2023-10-02

Start date

2023-10-19

Completion date

2025-07-09

Last updated

2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Overweight, Type 1 Diabetes Mellitus

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.

Interventions

DRUGCT-868

CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device.

DEVICECT-868 Pen Injector

The CT-868 pen injector is a multi-dose, single-participant, disposable pen.

DRUGCT-868 Pen Injector, Placebo

The placebo pen injector is identical and contains the same ingredients except for CT-868.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
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

Other

Measure	Time frame
Time in hyperglycemia as per CGM metrics.	at Day 1 to Week 16
Time In Range (TIR) as per Continuous Glucose Monitoring (CGM) metrics.	at Day 1 to Week 16
Time in hypoglycemia as per CGM metrics.	at Day 1 to Week 16

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026