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

Altimmune

Status and phase: Completed; Phase 1

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Drug: ALT-801; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05006885

ALT-801-105

Details and patient eligibility

About

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).

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 4 patient groups, including a placebo group

ALT-801 Dose Level 1

Experimental group

Description:

Administered once a week for 12 weeks

Treatment:

Drug: ALT-801

ALT-801 Dose Level 2

Experimental group

Description:

Administered once a week for 12 weeks

Treatment:

Drug: ALT-801

ALT-801 Dose Level 3

Experimental group

Description:

Administered once a week for 12 weeks

Treatment:

Drug: ALT-801

Placebo

Placebo Comparator group

Description:

Administered once a week for 12 weeks

Treatment:

Other: Placebo