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Die klinische Studie NCT06062069 für Übergewicht, Adipös, Typ-1-Diabetes mellitus ist abgeschlossen. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
A Study of CT-868 in Type 1 Diabetes Mellitus Phase 2 111 Ernährung Bewegung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06062069 untersuchte Behandlung im Zusammenhang mit Übergewicht, Adipös, Typ-1-Diabetes mellitus. Diese interventionsstudie der Phase 2 hat den Status abgeschlossen. Die Studie begann am 19. Oktober 2023 mit 111 Teilnehmern. Sie wurde durchgeführt von Carmot Therapeutics, Inc. und am 9. Juli 2025 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 17. Juli 2025 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Offizieller 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
Erkrankungen
ÜbergewichtAdipösTyp-1-Diabetes mellitusWeitere Studien-IDs
- CT-868-004
NCT-Nummer
Studienbeginn (tatsächlich)
2023-10-19
Zuletzt aktualisiert
2025-07-17
Studienende (vorauss.)
2025-07-09
Geplante Rekrutierung
111
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Abgeschlossen
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellCT-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. |
ExperimentellCT-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. |
ExperimentellCT-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-VergleichspräparatCT-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. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline | at Day 1 to Week 16 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- 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.Keine Kontaktdaten vorhanden
22 Studienstandorte in 1 Ländern
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