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ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease

NCT05006885•Altimmune, Inc.

View on ClinicalTrials.gov

Summary

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).

Detailed Description

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with NAFLD.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (15)

Headlands Research Scottsdale

Scottsdale, Arizona, United States

QLMC

Tucson, Arizona, United States

Catalina Research Institute

Montclair, California, United States

Clinical Trials Research

Sacramento, California, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Covenant Research and Clinics

Sarasota, Florida, United States

Headlands Research Sarasota

Sarasota, Florida, United States

Wake Research CRCN

Las Vegas, Nevada, United States

Accelemed Research Institute

Austin, Texas, United States

Pinnacle Research

Austin, Texas, United States

Key Dates

Start Date

September 30, 2021

Primary Completion Date

August 17, 2022

Completion Date

August 17, 2022

Last Updated

July 27, 2023

Enrollment

ACTUAL participants

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

ALT-801

DRUG

Placebo

OTHER

Identification of Liver Fibrosis Biomarkers

NCT06819917

Non-alcoholic Fatty LiverNon-Alcoholic Fatty Liver Disease+1 more

View study

RECRUITINGPHASE3

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

NCT07221227

Non-alcoholic Fatty Liver Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

Nonalcoholic Steatohepatitis in Chinese Children

OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities