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

• Sponsor: Altimmune, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05006885
• Collaborator: (none)
• Enrollment: 72
• Locations: 15
• Arms: 4
• Anticipated Duration (Months): 10
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Drug: ALT-801; Other: Placebo	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 30, 2021
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ALT-801 Dose Level 1 Administered once a week for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC); Other Names: Pemvidutide
Experimental: ALT-801 Dose Level 2 Administered once a week for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC); Other Names: Pemvidutide
Experimental: ALT-801 Dose Level 3 Administered once a week for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC); Other Names: Pemvidutide
Placebo Comparator: Placebo Administered once a week for 12 weeks	Other: Placebo; Injected subcutaneously (SC)

Outcome Measures

Primary Outcome Measures

1. The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) [Up to Day 110]

   Number of participants with 1 or more TEAEs up to Day 110

Secondary Outcome Measures

1. Change from baseline in liver fat fraction by MRI-PDFF [Baseline and Day 85]

   Change in liver fat fraction by MRI-PDFF from Baseline to Day 85

2. Change from baseline in body weight [Baseline and Day 85]

   Change in body weight from Baseline to Day 85

3. Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions) [Baseline and Day 85]

   Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85

4. Change from baseline in hemoglobin A1c [Baseline and Day 85]

   Change in hemoglobin A1c from Baseline to Day 85

5. Change from baseline in fibrosis markers (Pro-C3) [Baseline and Day 85]

   Change in fibrosis markers (Pro-C3) from Baseline to Day 85

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Headlands Research Scottsdale	Scottsdale	Arizona	United States	85260
2	QLMC	Tucson	Arizona	United States	85712
3	Catalina Research Institute	Montclair	California	United States	91763
4	Clinical Trials Research	Sacramento	California	United States	95648
5	Panax Clinical Research	Miami Lakes	Florida	United States	33014
6	Covenant Research and Clinics	Sarasota	Florida	United States	34240
7	Headlands Research Sarasota	Sarasota	Florida	United States	34243
8	Wake Research CRCN	Las Vegas	Nevada	United States	89106
9	Accelemed Research Institute	Austin	Texas	United States	78745
10	Pinnacle Research	Austin	Texas	United States	78757
11	South Texas Research Institute	Brownsville	Texas	United States	78520
12	South Texas Research Institute	Edinburg	Texas	United States	78539
13	Diagnostics Research Group	San Antonio	Texas	United States	78229
14	Pinnacle Research	San Antonio	Texas	United States	78229
15	Cognitive Clinical Trials	Salt Lake City	Utah	United States	84117

Sponsors and Collaborators

• Altimmune, Inc.

Investigators

• Study Director: Sarah K Browne, MD, Altimmune, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Altimmune, Inc.
• ClinicalTrials.gov Identifier: NCT05006885
• Other Study ID Numbers: ALT-801-105
• First Posted: Aug 16, 2021
• Last Update Posted: Jul 5, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Altimmune, Inc.: Obese; Overweight
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight

Study Results

No Results Posted as of Jul 5, 2022