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NCT06062069CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
111 (actual)
First submitted
14 Sept 2023
Start date
27 Nov 2023
Primary completion date
7 Jul 2025
Lead sponsor
Carmot Therapeutics, Inc.
NCT number
NCT06062069

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 111
  • From 27 Nov 2023 to the primary completion date, 7 Jul 2025
  • 22 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of North Carolina Health Sciences at MAHEC
Coordinator of this site? Confirm its status
AshevilleUnited StatesUnknown status
Atlanta Diabetes Associates
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
University of Colorado - Barbara Davis Center for Diabetes
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Texas Diabetes and Endocrinology, P.A
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
University of North Carolina at Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
John Muir Physician Network Clinical Research Center
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ConcordUnited StatesUnknown status
Velocity Clinical Research, Dallas
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DallasUnited StatesUnknown status
Research Institute Of Dallas
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DallasUnited StatesUnknown status
Denver Endocrinology Diabetes and Thyroid Center
Coordinator of this site? Confirm its status
EnglewoodUnited StatesUnknown status
Headlands Research AMCR
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EscondidoUnited StatesUnknown status
MedStar Health Research Institute - Washington Hospital Center
Coordinator of this site? Confirm its status
HyattsvilleUnited StatesUnknown status
Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho
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Idaho FallsUnited StatesUnknown status
Lucas Research, Inc.
Coordinator of this site? Confirm its status
Morehead CityUnited StatesUnknown status
Orlando Health Science Clinic, LLC
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Advent Health
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OrlandoUnited StatesUnknown status
Innovative Research Institute
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Port CharlotteUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Rainier Clinical Research Center
Coordinator of this site? Confirm its status
RentonUnited StatesUnknown status
Diabetes & Glandular Disease Clinic, P.A.
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Consano Clinical Research
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Shavano ParkUnited StatesUnknown status
Texas Valley Clinical Research, LLC
Coordinator of this site? Confirm its status
WeslacoUnited StatesUnknown status
Iowa Diabetes and Endocrinology Research Center
Coordinator of this site? Confirm its status
West Des MoinesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.