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DD01 for Obesity

Phase 1
Recruiting
Research Sponsored by Neuraly, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 2 diabetes ≥ 12 months.
Treatment with diet and exercise or metformin monotherapy on stable dose for 3 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part b - 57 days
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in people with type 2 diabetes and nonalcoholic fatty liver disease. The study will be conducted in 2 parts, with 8 cohorts in each part.

Eligible Conditions
  • Obesity
  • Type 2 Diabetes
  • Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
+5 more
Secondary outcome measures
Apparent blood/plasma terminal elimination half life of DD01
Apparent total blood/plasma clearance of DD01
Apparent volume of distribution of DD01
+8 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
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
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Neuraly, Inc.Lead Sponsor
3 Previous Clinical Trials
371 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Combined Research Orlando
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~29 spots leftby Mar 2025