NCT05292911

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

July 27, 2023

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

March 15, 2022

Last Update Submit

July 24, 2023

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

ObeseOverweight

Outcome Measures

Primary Outcomes (1)

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

    Number of participants with one or more TEAEs

    Up to Day 110

Secondary Outcomes (5)

  • Change from baseline in liver fat fraction by MRI-PDFF

    Baseline to Day 85

  • Change from baseline in body weight

    Baseline to Day 85

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

    Baseline to Day 85

  • Change from baseline in hemoglobin A1c

    Baseline to Day 85

  • Change from baseline in fibrosis markers (Pro-C3)

    Baseline to Day 85

Study Arms (4)

ALT-801 Dose Level 1

EXPERIMENTAL

Administered once a week for 12 weeks

Drug: ALT-801

ALT-801 Dose Level 2

EXPERIMENTAL

Administered once a week for 12 weeks

Drug: ALT-801

ALT-801 Dose Level 3

EXPERIMENTAL

Administered once a week for 12 weeks

Drug: ALT-801

Placebo

PLACEBO COMPARATOR

Administered once a week for 12 weeks

Other: Placebo

Interventions

ALT-801DRUG

Injected subcutaneously (SC)

Also known as: Pemvidutide
ALT-801 Dose Level 1ALT-801 Dose Level 2ALT-801 Dose Level 3
PlaceboOTHER

Injected subcutaneously (SC)

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Development of any of the following conditions at any time during Study ALT-801-105:
  • Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105
  • History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Catalina Research Institute

Montclair, California, 91763, United States

Location

Clinical Trials Research

Sacramento, California, 95648, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Covenant Research and Clinics

Sarasota, Florida, 34240, United States

Location

Headlands Research Sarasota

Sarasota, Florida, 34243, United States

Location

Wake Research CRCN

Las Vegas, Nevada, 89106, United States

Location

Accelemed Research Institute

Austin, Texas, 78745, United States

Location

Pinnacle Research

Austin, Texas, 78757, United States

Location

South Texas Research Institute

Brownsville, Texas, 78520, United States

Location

South Texas Research Institute

Edinburg, Texas, 78539, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Pinnacle Research

San Antonio, Texas, 78229, United States

Location

Cognitive Clinical Trials

Salt Lake City, Utah, 84117, United States

Location

Related Publications (1)

  • Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Georges B, Roberts MS, Harris MS. Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. JHEP Rep. 2025 Jun 18;7(11):101483. doi: 10.1016/j.jhepr.2025.101483. eCollection 2025 Nov.

    PMID: 41113119DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityOverweight

Interventions

ALT-801

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sarah K Browne, MD

    Altimmune, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

March 23, 2022

Study Start

March 9, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

July 27, 2023

Record last verified: 2022-10

Locations

US(13)