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Peptide

Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 110

Summary

This trial will test the safety and effects of ALT-801 over several months in people who are overweight or obese and have a liver condition called NAFLD. It includes both diabetic and non-diabetic participants. The goal is to see if ALT-801 can improve their liver health and help them lose weight.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

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

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

Side effects data

From 2016 Phase 1 & 2 trial • 68 Patients • NCT01326871
100%
Platelet count decreased
100%
Nausea
100%
Vomiting
100%
Neutrophil count decreased
100%
Pruritus
100%
Rash maculo-papular
67%
Pyrexia
67%
Fatigue
67%
Constipation
67%
White blood cell count decreased
67%
Anaemia
67%
Dry skin
33%
Pain
33%
Aspartate aminotransferase increased
33%
Blood alkaline phosphatase increased
33%
Chills
33%
Oedema peripheral
33%
Influenza like illness
33%
Dyspepsia
33%
Alanine aminotransferase increased
33%
Weight increased
33%
Hyponatraemia
33%
Hypophosphataemia
33%
Lymphocyte count decreased
33%
Decreased appetite
33%
Hypoalbuminaemia
33%
Hypocalcaemia
33%
Alopecia
33%
Cough
33%
Rhinitis allergic
33%
Headache
33%
Hypotension
33%
Skin infection
33%
Cystitis
33%
Fall
33%
Contusion
33%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
ALT-801 0.06 mg/kg With Gemcitabine

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
~840

Find a Location

Who is running the clinical trial?

Altimmune, Inc.Lead Sponsor
16 Previous Clinical Trials
1,481 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
425 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Sarah K Browne, MDStudy DirectorAltimmune, Inc.
2 Previous Clinical Trials
486 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
95 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~17 spots leftby Dec 2025
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