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A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
Phase 1
Waitlist Available
Research Sponsored by Neuraly, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part b - 57 days
Summary
This trial tests a new drug called DD01 in overweight or obese individuals with type 2 diabetes and nonalcoholic fatty liver disease. The drug is given as an injection, and researchers will monitor its safety and effectiveness.
Eligible Conditions
- Diabetes
- Obesity
- Non-alcoholic Fatty Liver Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part b - 57 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part b - 57 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Apparent blood/plasma terminal elimination half life of DD01
Apparent total blood/plasma clearance of DD01
Apparent volume of distribution of DD01
+7 moreTrial Design
15Treatment groups
Experimental Treatment
Group I: Group B8 - Multiple Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group II: Group B7 - Multiple Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group III: Group B6 - Multiple Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group IV: Group B5 - Multiple Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group V: Group B4 - Multiple Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group VI: Group B3 - Multiple Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group VII: Group B2 - Multiple Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection once weekly for 4 weeks
Group VIII: Group A8, Single Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group IX: Group A7, Single Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group X: Group A6, Single Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group XI: Group A5, Single Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group XII: Group A4, Single Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 4 (N=6) Placebo (N=2) Subcutaneous injection
Group XIII: Group A3, Single Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 3 (N=6) Placebo (N=2) Subcutaneous injection
Group XIV: Group A2, Single Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 2 (N=6) Placebo (N=2) Subcutaneous injection
Group XV: Group A1 - Single Ascending DoseExperimental Treatment2 Interventions
DD01 Dose 1 (N=6) Placebo (N=2) Subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DD01
2021
Completed Phase 1
~260
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Neuraly, Inc.Lead Sponsor
4 Previous Clinical Trials
439 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
68 Patients Enrolled for Non-alcoholic Fatty Liver Disease