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

Altimmune

Status and phase: Completed; Phase 1

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Other: Placebo; Drug: ALT-801

Study type: Interventional

Funder types: Industry

Identifiers

NCT05292911

ALT-801-106

Details and patient eligibility

About

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).

Full 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).

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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 exclusion criteria in Study ALT-801-105 at the time of study entry

• Development of any of the following conditions at any time during Study ALT-801-105:

  1. Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105
  2. 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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64 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