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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05006885

Enrollment

Registered

2021-08-16

Start date

2021-09-30

Completion date

2022-08-17

Last updated

2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Obese, Overweight

Brief 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.

Interventions

DRUGALT-801

Injected subcutaneously (SC)

OTHERPlacebo

Injected subcutaneously (SC)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)	Up to Day 110	Number of participants with 1 or more TEAEs up to Day 110

Secondary

Measure	Time frame	Description
Change from baseline in liver fat fraction by MRI-PDFF	Baseline and Day 85	Change in liver fat fraction by MRI-PDFF from Baseline to Day 85
Change from baseline in body weight	Baseline and Day 85	Change in body weight from Baseline to Day 85
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)	Baseline and Day 85	Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85
Change from baseline in hemoglobin A1c	Baseline and Day 85	Change in hemoglobin A1c from Baseline to Day 85
Change from baseline in fibrosis markers (Pro-C3)	Baseline and Day 85	Change in fibrosis markers (Pro-C3) from Baseline to Day 85

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026