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Clinical Trial Details

Trial ID: L2501
Source ID: NCT05134662
Associated Drug: Alt-801
Title: ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: ALT-801|OTHER: Placebo
Outcome Measures: Primary: The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs), Up to Day 110|Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin, Baseline to Day 85|Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2), Baseline to Day 85 | Secondary: Change from baseline in fasting serum glucose, Baseline to Day 85|Change from baseline in hemoglobin A1c (HbA1c), Baseline to Day 85 | Other: Changes in quality of life questionnaires compared to baseline, Baseline to Day 85|ALT-801 concentrations, Baseline to Day 110|Change from baseline metformin concentrations, Baseline to Day 85
Sponsor/Collaborators: Sponsor: Altimmune, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 55
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-02-01
Completion Date: 2023-03-09
Results First Posted:
Last Update Posted: 2023-08-14
Locations: Altimmune CTM, Fort Myers, Florida, 33900, United States|Altimmune CTM, Sarasota, Florida, 34230, United States|Altimmune CTM, River Forest, Illinois, 60305, United States|Altimmune CTM, Kansas City, Missouri, 64101, United States|Altimmune CTM, Knoxville, Tennessee, 37922, United States|Altimmune CTM, San Antonio, Texas, 78201, United States|Altimmune CTM, Tomball, Texas, 77375, United States
URL: https://clinicaltrials.gov/show/NCT05134662

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress