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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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 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

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 1 or more TEAEs up to Day 110 | 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 liver fat fraction by MRI-PDFF from Baseline to Day 85 | Baseline and Day 85 | 
| Change from baseline in body weight | Change in body weight from Baseline to Day 85 | Baseline and Day 85 | 
| Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions) | Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85 | Baseline and Day 85 | 
| Change from baseline in hemoglobin A1c | Change in hemoglobin A1c from Baseline to Day 85 | Baseline and Day 85 | 
| Change from baseline in fibrosis markers (Pro-C3) | Change in fibrosis markers (Pro-C3) from Baseline to Day 85 | Baseline and Day 85 | 

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