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

A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05292911

Enrollment

Registered

2022-03-23

Start date

2022-03-09

Completion date

2022-10-31

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

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).

Detailed description

This extension study will enroll subjects who have completed 12 weeks of treatment in Study ALT-801-105. It is designed to allow for an additional 12 weeks of treatment in order to 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

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 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

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 one or more TEAEs

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026