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

• ClinicalTrials.gov Identifier: NCT05292911
• Recruitment Status: Active, not recruiting
• First Posted: March 23, 2022
• Last Update Posted: October 12, 2022
• Sponsor: Altimmune, Inc.
• Information provided by (Responsible Party): Altimmune, Inc.

Tracking Information

• First Submitted Date: March 15, 2022
• First Posted Date: March 23, 2022
• Last Update Posted Date: October 12, 2022
• Actual Study Start Date: March 9, 2022
• Actual Primary Completion Date: October 4, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 30, 2022)

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

Number of participants with one or more TEAEs

• Original Primary Outcome Measures (submitted: March 15, 2022): The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Day 110 ]

Current Secondary Outcome Measures (submitted: June 30, 2022)

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

Original Secondary Outcome Measures (submitted: March 15, 2022)

• Change from baseline in liver fat fraction by MRI-PDFF [ Time Frame: Baseline to Day 85 ]
• Change from baseline in body weight [ Time Frame: Baseline to Day 85 ]
• Change from baseline in waist circumference [ Time Frame: Baseline to Day 85 ]
• Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions) [ Time Frame: Baseline to Day 85 ]
• Change from baseline in hemoglobin A1c [ Time Frame: Baseline to Day 85 ]
• Change from baseline in adiponectin [ Time Frame: Baseline to Day 85 ]
• Change from baseline in N-terminal type III collagen propeptide (Pro-C3) [ Time Frame: Baseline to Day 85 ]
• Change from baseline in fibrosis markers by cT1 MRI (corrected T1 magnetic resonance imaging) [ Time Frame: Baseline to Day 85 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
• Official Title: A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
• Brief Summary: 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: 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).
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Non-Alcoholic Fatty Liver Disease

Intervention

• Drug: ALT-801
  Injected subcutaneously (SC)
  Other Name: Pemvidutide
• Other: Placebo
  Injected subcutaneously (SC)

Study Arms

• Experimental: ALT-801 Dose Level 1
  Administered once a week for 12 weeks
  Intervention: Drug: ALT-801
• Experimental: ALT-801 Dose Level 2
  Administered once a week for 12 weeks
  Intervention: Drug: ALT-801
• Experimental: ALT-801 Dose Level 3
  Administered once a week for 12 weeks
  Intervention: Drug: ALT-801
• Placebo Comparator: Placebo
  Administered once a week for 12 weeks
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: June 30, 2022): 70
• Original Estimated Enrollment (submitted: March 15, 2022): 60
• Estimated Study Completion Date: November 2022
• Actual Primary Completion Date: October 4, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05292911
• Other Study ID Numbers: ALT-801-106
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Altimmune, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Altimmune, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Altimmune, Inc.
• Verification Date: October 2022