DD01 for Non-alcoholic Fatty Liver Disease

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and part b - 57 days for reporting.

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 more

Trial 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