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Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial) (IMPACT)

Primary Purpose

Non-Alcoholic Steatohepatitis (NASH)

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemvidutide
Placebo
Sponsored by
Altimmune, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent Male or female 18-75 years Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis [0-3], lobular inflammation [0-3], and hepatocyte ballooning [0-2]) NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment BMI ≥ 27.0 kg/m2 Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005) Liver fat content by MRI-PDFF ≥ 8% Exclusion Criteria: Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening History or clinical evidence of Type 1 diabetes mellitus Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia Liver conditions: History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites Documented causes of chronic liver disease other than NASH ALT or AST laboratory values > 5 × ULN

Sites / Locations

  • Altimmune Clinical Study SiteRecruiting
  • Altimmune Clinical Study SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Pemvidutide 1.2 mg (n=38)

Pemvidutide 1.8 mg (n=76)

Placebo (n=76)

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis
Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)

Secondary Outcome Measures

Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks
Relative change (%) in liver fat content by MRI-PDFF
Absolute change in MRI-based corrected T1 (cT1) imaging
Absolute change in alanine aminotransferase (ALT)
Absolute change in Enhanced Liver Fibrosis (ELF) score
Absolute change in Fibroscan-AST (FAST) score
Relative (%) change in body weight
Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Change in HbA1c (%)
Change in glucose (mg/dL)
Change in systolic and diastolic blood pressure (mmHg)
Change in heart rate (beats per minute)
The number of subjects with treatment emergent adverse events

Full Information

First Posted
July 24, 2023
Last Updated
August 10, 2023
Sponsor
Altimmune, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05989711
Brief Title
Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)
Acronym
IMPACT
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altimmune, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.
Detailed Description
A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind, Placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pemvidutide 1.2 mg (n=38)
Arm Type
Experimental
Arm Title
Pemvidutide 1.8 mg (n=76)
Arm Type
Experimental
Arm Title
Placebo (n=76)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pemvidutide
Intervention Description
Administered by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injection
Primary Outcome Measure Information:
Title
Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis
Time Frame
24 weeks
Title
Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks
Time Frame
24 weeks
Title
Relative change (%) in liver fat content by MRI-PDFF
Time Frame
24 weeks and 48 weeks
Title
Absolute change in MRI-based corrected T1 (cT1) imaging
Time Frame
24 weeks and 48 weeks
Title
Absolute change in alanine aminotransferase (ALT)
Time Frame
24 weeks and 48 weeks
Title
Absolute change in Enhanced Liver Fibrosis (ELF) score
Time Frame
24 weeks and 48 weeks
Title
Absolute change in Fibroscan-AST (FAST) score
Time Frame
24 weeks and 48 weeks
Title
Relative (%) change in body weight
Time Frame
24 weeks and 48 weeks
Title
Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Time Frame
24 weeks and 48 weeks
Title
Change in HbA1c (%)
Time Frame
24 weeks and 48 weeks
Title
Change in glucose (mg/dL)
Time Frame
24 weeks and 48 weeks
Title
Change in systolic and diastolic blood pressure (mmHg)
Time Frame
24 weeks and 48 weeks
Title
Change in heart rate (beats per minute)
Time Frame
24 weeks and 48 weeks
Title
The number of subjects with treatment emergent adverse events
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent Male or female 18-75 years Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis [0-3], lobular inflammation [0-3], and hepatocyte ballooning [0-2]) NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment BMI ≥ 27.0 kg/m2 Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005) Liver fat content by MRI-PDFF ≥ 8% Exclusion Criteria: Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening History or clinical evidence of Type 1 diabetes mellitus Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia Liver conditions: History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites Documented causes of chronic liver disease other than NASH ALT or AST laboratory values > 5 × ULN
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Altimmune CTM
Phone
2406541450
Email
information@altimmune.com
Facility Information:
Facility Name
Altimmune Clinical Study Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Altimmune Study Director
Facility Name
Altimmune Clinical Study Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Altimmune Study Director

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)

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