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Immunotherapy

ALT-801 for Non-alcoholic Fatty Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Altimmune, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female volunteers, age 18 to 65 years, inclusive
Overweight to obese (greater than or equal to BMI 28.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 110
Awards & highlights

Study Summary

This trial will test a new drug, ALT-801, to see if it is safe and tolerable for people with diabetes, obesity, and non-alcoholic fatty liver disease.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a high proton density fat fraction on magnetic resonance imaging.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 110
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 110 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Change from baseline in body weight
Change from baseline in fibrosis markers (Pro-C3)
Change from baseline in hemoglobin A1c
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ALT-801 Dose Level 3Experimental Treatment1 Intervention
Administered once a week for 12 weeks
Group II: ALT-801 Dose Level 2Experimental Treatment1 Intervention
Administered once a week for 12 weeks
Group III: ALT-801 Dose Level 1Experimental Treatment1 Intervention
Administered once a week for 12 weeks
Group IV: PlaceboPlacebo Group1 Intervention
Administered once a week for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALT-801
2010
Completed Phase 2
~770

Find a Location

Who is running the clinical trial?

Altimmune, Inc.Lead Sponsor
16 Previous Clinical Trials
1,443 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
394 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Sarah K Browne, MDStudy DirectorAltimmune, Inc.
2 Previous Clinical Trials
455 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
64 Patients Enrolled for Non-alcoholic Fatty Liver Disease

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?
Panax Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
~28 spots leftby Mar 2025