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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT05292911 (opens ClinicalTrials.gov in a new tab)Other idALT-801-106
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
9 Mar 2022
Primary completion
31 Oct 2022
Completion
31 Oct 2022
First posted
23 Mar 2022
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
20222023
  1. Ph 1

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

    NCT05292911

    9 Mar 2022 to 31 Oct 2022

Registry summary

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

This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity 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 one or more TEAEs

Secondary outcomes(5)

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

    Time frame · Baseline to Day 85

    Registry description

    Change in MRI-PDFF

  2. Change from baseline in body weight

    Time frame · Baseline to Day 85

    Registry description

    Change in body weight

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

    Time frame · Baseline to Day 85

    Registry description

    Change in lipid metabolism (TC, HDL, LDL)

  4. Change from baseline in hemoglobin A1c

    Time frame · Baseline to Day 85

    Registry description

    Change in hemoglobin A1c

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

    Time frame · Baseline to Day 85

    Registry description

    Change in fibrosis markers (Pro-C3)

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

PubMed tag: none · 2025

7 results

Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial.

Browne et al. 2025JHEP reports : innovation in hepatologycited by 5

PMID 41113119PMC12529369DOI 10.1016/j.jhepr.2025.101483PUB-41113119

CC BY7 results
Download PDFSee results (7)

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 to participate in this extension study, signed prior to the performance of any study procedures * Receipt of 12 weeks of investigational product with completion of the procedures in Study ALT-801-105 * Women who are not pregnant or breastfeeding Exclusion Criteria: * Meets any of the exclusion criteria in Study ALT-801-105 at the time of study entry * Development of any of the following conditions at any time during Study ALT-801-105: 1. Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105 2. History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

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