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De klinische studie NCT06062069 voor Overgewicht, Obees, Type 1 diabetes mellitus is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
A Study of CT-868 in Type 1 Diabetes Mellitus Fase 2 111 Dieet Lichaamsbeweging
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De klinische studie NCT06062069 onderzocht behandeling bij Overgewicht, Obees, Type 1 diabetes mellitus. Deze Fase 2 interventioneel studie is nu afgerond. Er werd gestreefd naar inclusie van 111 deelnemers vanaf 19 oktober 2023. De studie werd geleid door Carmot Therapeutics, Inc. en was gepland te worden voltooid op 9 juli 2025. Laatste update op ClinicalTrials.gov: 17 juli 2025.
Beknopte samenvatting
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 rece...Toon meer
Officiële titel
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
Aandoeningen
OvergewichtObeesType 1 diabetes mellitusAndere studie-ID's
- CT-868-004
NCT-ID
Startdatum (Werkelijk)
2023-10-19
Laatste update geplaatst
2025-07-17
Verwachte einddatum
2025-07-09
Inschrijving (Geschat)
111
Studietype
Interventioneel
FASE
Fase 2
Status
Afgerond
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Viervoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelCT-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. | CT-868 CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device. CT-868 Pen Injector The CT-868 pen injector is a multi-dose, single-participant, disposable pen. |
ExperimenteelCT-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. | CT-868 CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device. CT-868 Pen Injector The CT-868 pen injector is a multi-dose, single-participant, disposable pen. |
ExperimenteelCT-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. | CT-868 CT-868 is an investigational medication administered subcutaneously via a pre-filled pen injector device. CT-868 Pen Injector The CT-868 pen injector is a multi-dose, single-participant, disposable pen. |
Placebo-comparatorCT-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. | CT-868 Pen Injector The CT-868 pen injector is a multi-dose, single-participant, disposable pen. CT-868 Pen Injector, Placebo The placebo pen injector is identical and contains the same ingredients except for CT-868. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline | at Day 1 to Week 16 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 | |
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
- 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
Carmot Therapeutics, Inc.Geen contactgegevens beschikbaar
22 Studielocaties in 1 landen
California
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States
Headlands Research- AMCR, Escondido, California, 92025, United States
Colorado
University of Colorado - Barbara Davis Center for Diabetes, Aurora, Colorado, 80045, United States
Denver Endocrinology Diabetes and Thyroid Center, Englewood, Colorado, 80113, United States
Florida
Advent Health, Orlando, Florida, 32804, United States
Orlando Health Science Clinic, LLC, Orlando, Florida, 32822, United States
Innovative Research Institute, Port Charlotte, Florida, 33952, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30309, United States
Idaho
Rocky Mountain Clinical Research, LLC- Idaho Falls, Idaho, Idaho Falls, Idaho, 83404, United States
Iowa
Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50266, United States
Maryland
MedStar Health Research Institute - Washington Hospital Center, Hyattsville, Maryland, 20782, United States
North Carolina
University of North Carolina Health Sciences at MAHEC, Asheville, North Carolina, 28803, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27517, United States
Lucas Research, Inc, Morehead City, North Carolina, 28557, United States
Oregon
Oregon Health and Science University, Portland, Oregon, 97239, United States
Texas
Texas Diabetes and Endocrinology, P.A, Austin, Texas, 78731, United States
Velocity Clinical Research - Dallas, Dallas, Texas, 75230, United States
Research Institute of Dallas, Dallas, Texas, 75231, United States
Diabetes & Glandular Disease Clinic, P.A., San Antonio, Texas, 78229, United States
Consano Clinical Research, Shavano Park, Texas, 78231, United States
Texas Valley Clinical Research, LLC, Weslaco, Texas, 78596, United States
Washington
Rainier Clinical Research Center, Renton, Washington, 98057, United States