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Trial · Interventional

CompletedPhase 1Registry data

ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

NCTNCT05006885 (opens ClinicalTrials.gov in a new tab)Other idALT-801-105
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
95 participants (actual)
Sponsor
Altimmune, Inc. · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
30 Sept 2021
Primary completion
17 Aug 2022
Completion
17 Aug 2022
First posted
16 Aug 2021
Last update posted
27 Jul 2023
Conditions
Non-Alcoholic Fatty Liver Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 1

    ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

    NCT05006885

    30 Sept 2021 to 17 Aug 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).

Interventions

  • ALT-801Drug
  • PlaceboOther

Arms4

  • Experimental

    ALT-801 Dose Level 1

    Administered once a week for 12 weeks

  • Experimental

    ALT-801 Dose Level 2

    Administered once a week for 12 weeks

  • Experimental

    ALT-801 Dose Level 3

    Administered once a week for 12 weeks

  • Placebo comparator

    Placebo

    Administered once a week for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

    Time frame · Up to Day 110

    Registry description

    Number of participants with 1 or more TEAEs up to Day 110

Secondary outcomes(5)

  1. Change from baseline in liver fat fraction by MRI-PDFF

    Time frame · Baseline and Day 85

    Registry description

    Change in liver fat fraction by MRI-PDFF from Baseline to Day 85

  2. Change from baseline in body weight

    Time frame · Baseline and Day 85

    Registry description

    Change in body weight from Baseline to Day 85

  3. Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)

    Time frame · Baseline and Day 85

    Registry description

    Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85

  4. Change from baseline in hemoglobin A1c

    Time frame · Baseline and Day 85

    Registry description

    Change in hemoglobin A1c from Baseline to Day 85

  5. Change from baseline in fibrosis markers (Pro-C3)

    Time frame · Baseline and Day 85

    Registry description

    Change in fibrosis markers (Pro-C3) from Baseline to Day 85

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

11 results

Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study.

Harrison et al. 2025Journal of hepatologycited by 134

PMID 39002641DOI 10.1016/j.jhep.2024.07.006PUB-39002641

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Written informed consent signed prior to the performance of any study procedures * Male or female volunteers, age 18 to 65 years, inclusive * Overweight to obese (greater than or equal to BMI 28.0 * Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10% * If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy Exclusion Criteria: * Women who are pregnant or breastfeeding * Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5% * History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

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