| Trial ID: | L0225 |
| Source ID: | NCT04812262
|
| Associated Drug: |
DD01
|
| Title: |
A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Overweight and Obesity|Type2 Diabetes|NAFLD
|
| Interventions: |
Drug: DD01|Drug: Placebo
|
| Outcome Measures: |
Number of participants with treatment-related adverse events and serious adverse events|Number of participants with treatment-related adverse events and serious adverse events (TEAEs)|Number of participants with clinically significant abnormalities in clinical laboratory values|Number of participants with clinically significant abnormalities in physical examinations|Number of participants with clinically significant abnormalities in vital signs|Blood Pressure assessed by 24-hour ambulatory blood pressure monitoring (ABPM)|Heart Rate assessed by 24-hour ambulatory electrocardiography monitoring reader)|Number of participants with clinically significant abnormalities in 12-lead ECGs|Maximum observed blood/plasma concentration of DD01|Time of the maximum observed blood/plasma concentration of DD01|Apparent blood/plasma terminal elimination half life of DD01|Termination elimination rate constant of DD01|Apparent total blood/plasma clearance of DD01|Apparent volume of distribution of DD01|Area under the blood/plasma concentration time curve from time zero to the time of the last quantifiable concentration of DD01|Area under the blood/plasma concentration time curve from time zero to 144 hours postdose of DD01|Area under the blood/plasma concentration time curve from time zero to 216 hours postdose of DD01|Area under the blood/plasma concentration time curve from time zero to 168 hours postdose of DD01|Number of participants with antidrug antibodies (ADAs)
|
| Sponsor/Collaborators: |
Neuraly, Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
88
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
February 24, 2021
|
| Completion Date: |
July 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
March 4, 2022
|
| Locations: |
Prosciento, Chula Vista, California, United States|Southwest General Healthcare Center, Fort Myers, Florida, United States|Combined Research Orlando, Orlando, Florida, United States|FDI Clinical Research, San Juan, Puerto Rico
|
| URL: |
https://ClinicalTrials.gov/show/NCT04812262
|
