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

Non-Alcoholic Steatohepatitis (NASH) Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989711
• Other study ID #: ALT- 801-203
• Status: Recruiting
• Phase: Phase 2
• Start date: July 27, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Altimmune, Inc.
• Contact: Altimmune CTM
• Phone: 2406541450
• Email: information[@]altimmune.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.

Description:

A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: September 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Written informed consent

2. Male or female 18-75 years

3. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening

1. 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])

2. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation

4. 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

5. BMI = 27.0 kg/m2

6. 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

7. Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005)

8. Liver fat content by MRI-PDFF = 8%

Exclusion Criteria:

1. Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening

2. History or clinical evidence of Type 1 diabetes mellitus

3. Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia

4. Liver conditions:

1. History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites

2. Documented causes of chronic liver disease other than NASH

3. ALT or AST laboratory values > 5 × ULN

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis (NASH)

Intervention

Drug:
• Pemvidutide
Administered by subcutaneous injection
• Placebo
Administered by subcutaneous injection

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Box Hill Hospital	Box Hill	Victory
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Hospital	Clayton	Victory
Australia	St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Austin Health	Heidelberg	Victoria
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Princess Alexandra Hospital/ Translational Research Institute	Woolloongabba	Queensland
Puerto Rico	Altimmune Clinical Study Site	San Juan
United States	Altimmune Clinical Study Site	Austin	Texas
United States	Altimmune Clinical Study Site	Bastrop	Louisiana
United States	Altimmune Clinical Study Site	Bellaire	Texas
United States	Altimmune Clinical Study Site	Bradenton	Florida
United States	Altimmune Clinical Study Site	Chandler	Arizona
United States	Altimmune Clinical Study Site	Clarksville	Tennessee
United States	Altimmune Clinical Study Site	Dalton	Georgia
United States	Altimmune Clinical Study Site	Edinburg	Texas
United States	Altimmune Clinical Study Site	Edinburg	Texas
United States	Altimmune Clinical Study Site	Englewood	Colorado
United States	Altimmune Clinical Study Site	Fort Myers	Florida
United States	Altimmune Clinical Study Site	Georgetown	Texas
United States	Altimmune Clinical Study Site	Germantown	Tennessee
United States	Altimmune Clinical Study Site	Hialeah Gardens	Florida
United States	Altimmune Clinical Study Site	Houston	Texas
United States	Altimmune Clinical Study Site	Marietta	Georgia
United States	Altimmune Clinical Study Site	Miami Lakes	Florida
United States	Altimmune Clinical Study Site	North Hollywood	California
United States	Altimmune Clinical Study Site	Panorama City	California
United States	Altimmune Clinical Study Site	Peoria	Arizona
United States	Altimmune Clinical Study Site	Port Orange	Florida
United States	Altimmune Clinical Study Site	San Antonio	Texas
United States	Altimmune Clinical Study Site	San Antonio	Texas
United States	Altimmune Clinical Study Site	Sarasota	Florida
United States	Altimmune Clinical Study Site	Shreveport	Louisiana
United States	Altimmune Clinial Study Site	Tucson	Arizona
United States	Altimmune Clinical Study Site	Tucson	Arizona
United States	Altimmune Clinical Study Site	West Jordan	Utah
United States	Altimmune Clinical Study Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Altimmune, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 weeks
Primary	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)		24 weeks
Secondary	Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks		24 weeks
Secondary	Relative change (%) in liver fat content by MRI-PDFF		24 weeks and 48 weeks
Secondary	Absolute change in MRI-based corrected T1 (cT1) imaging		24 weeks and 48 weeks
Secondary	Absolute change in alanine aminotransferase (ALT)		24 weeks and 48 weeks
Secondary	Absolute change in Enhanced Liver Fibrosis (ELF) score		24 weeks and 48 weeks
Secondary	Absolute change in Fibroscan-AST (FAST) score		24 weeks and 48 weeks
Secondary	Relative (%) change in body weight		24 weeks and 48 weeks
Secondary	Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)		24 weeks and 48 weeks
Secondary	Change in HbA1c (%)		24 weeks and 48 weeks
Secondary	Change in glucose (mg/dL)		24 weeks and 48 weeks
Secondary	Change in systolic and diastolic blood pressure (mmHg)		24 weeks and 48 weeks
Secondary	Change in heart rate (beats per minute)		24 weeks and 48 weeks
Secondary	The number of subjects with treatment emergent adverse events		48 weeks