NCT06062069

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Carmot Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight
• Obese
• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
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.
DRUG	CT-868 Pen Injector, Placebo	The placebo pen injector is identical and contains the same ingredients except for CT-868.

Timeline

• Start date: 2023-10-19
• Primary completion: 2025-07-09
• Completion: 2025-07-09
• First posted: 2023-10-02
• Last updated: 2025-07-17

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study