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Clinical Trial Details

Trial ID: L3977
Source ID: NCT06062069
Associated Drug: Ct-868
Title: A Study of CT-868 in Type 1 Diabetes Mellitus
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Overweight|Obese|Type 1 Diabetes Mellitus
Interventions: DRUG: CT-868|DEVICE: CT-868 Pen Injector|DRUG: : CT-868 Pen Injector, Placebo
Outcome Measures: Primary: Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline, at Day 1 to Week 16 | Secondary: 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 | Other: 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|Time in hyperglycemia as per CGM metrics., at Day 1 to Week 16
Sponsor/Collaborators: Sponsor: Carmot Therapeutics, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 111
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-19
Completion Date: 2025-07-08
Results First Posted:
Last Update Posted: 2025-03-28
Locations: Carmot Therapeutics Investigational Site 121, Concord, California, 94520, United States|Carmot Therapeutics Investigational Site 125, Escondido, California, 92025, United States|Carmot Therapeutics Investigational Site 118, Aurora, Colorado, 80045, United States|Carmot Therapeutics Investigational Site 119, Englewood, Colorado, 80113, United States|Carmot Therapeutics Investigational Site 113, Orlando, Florida, 32804, United States|Carmot Therapeutics Investigational Site 112, Orlando, Florida, 32822, United States|Carmot Therapeutics Investigational Site 116, Port Charlotte, Florida, 33952, United States|Carmot Therapeutics Investigational Site 123, Atlanta, Georgia, 30309, United States|Carmot Therapeutics Investigational Site 126, Idaho Falls, Idaho, 83404, United States|Carmot Therapeutics Investigational Site 104, West Des Moines, Iowa, 50266, United States|Carmot Therapeutics Investigational Site 114, Hyattsville, Maryland, 20782, United States|Carmot Therapeutics Investigational Site 111, Asheville, North Carolina, 28803, United States|Carmot Therapeutics Investigational Site 110, Chapel Hill, North Carolina, 27517, United States|Carmot Therapeutics Investigational Site 102, Morehead City, North Carolina, 28557, United States|Carmot Therapeutics Investigational Site 122, Portland, Oregon, 97239, United States|Carmot Therapeutics Investigational Site 101, Austin, Texas, 78731, United States|Carmot Therapeutics Investigational Site 103, Dallas, Texas, 75230, United States|Carmot Therapeutics Investigational Site 105, Dallas, Texas, 75231, United States|Carmot Therapeutics Investigational Site 124, San Antonio, Texas, 78229, United States|Carmot Therapeutics Investigational Site 108, Shavano Park, Texas, 78231, United States|Carmot Therapeutics Investigational Site 115, Weslaco, Texas, 78596, United States|Carmot Therapeutics Investigational Site 109, Renton, Washington, 98057, United States
URL: https://clinicaltrials.gov/show/NCT06062069