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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Drug: ALT-801
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105 History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALT-801 Dose Level 1<br>Administered once a week for 12 weeks | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>* Other names: Pemvidutide;|
| Experimental: ALT-801 Dose Level 2<br>Administered once a week for 12 weeks | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>* Other names: Pemvidutide;|
| Experimental: ALT-801 Dose Level 3<br>Administered once a week for 12 weeks | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>* Other names: Pemvidutide;|
| Placebo Comparator: Placebo<br>Administered once a week for 12 weeks | Other: Placebo<br>* Injected subcutaneously (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) | Number of participants with one or more TEAEs | Up to Day 110 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obese, Overweight