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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05989711




Registration number
NCT05989711
Ethics application status
Date submitted
24/07/2023
Date registered
14/08/2023
Date last updated
16/05/2024

Titles & IDs
Public title
Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)
Scientific 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)
Secondary ID [1] 0 0
ALT- 801-203
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Alcoholic Steatohepatitis (NASH) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pemvidutide
Treatment: Drugs - Placebo

Experimental: Pemvidutide 1.2 mg (n=38) -

Experimental: Pemvidutide 1.8 mg (n=76) -

Placebo comparator: Placebo (n=76) -


Treatment: Drugs: Pemvidutide
Administered by subcutaneous injection

Treatment: Drugs: Placebo
Administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
24 weeks
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
24 weeks
Secondary outcome [1] 0 0
Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Relative change (%) in liver fat content by MRI-PDFF
Timepoint [2] 0 0
24 weeks and 48 weeks
Secondary outcome [3] 0 0
Absolute change in MRI-based corrected T1 (cT1) imaging
Timepoint [3] 0 0
24 weeks and 48 weeks
Secondary outcome [4] 0 0
Absolute change in alanine aminotransferase (ALT)
Timepoint [4] 0 0
24 weeks and 48 weeks
Secondary outcome [5] 0 0
Absolute change in Enhanced Liver Fibrosis (ELF) score
Timepoint [5] 0 0
24 weeks and 48 weeks
Secondary outcome [6] 0 0
Absolute change in Fibroscan-AST (FAST) score
Timepoint [6] 0 0
24 weeks and 48 weeks
Secondary outcome [7] 0 0
Relative (%) change in body weight
Timepoint [7] 0 0
24 weeks and 48 weeks
Secondary outcome [8] 0 0
Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Timepoint [8] 0 0
24 weeks and 48 weeks
Secondary outcome [9] 0 0
Change in HbA1c (%)
Timepoint [9] 0 0
24 weeks and 48 weeks
Secondary outcome [10] 0 0
Change in glucose (mg/dL)
Timepoint [10] 0 0
24 weeks and 48 weeks
Secondary outcome [11] 0 0
Change in systolic and diastolic blood pressure (mmHg)
Timepoint [11] 0 0
24 weeks and 48 weeks
Secondary outcome [12] 0 0
Change in heart rate (beats per minute)
Timepoint [12] 0 0
24 weeks and 48 weeks
Secondary outcome [13] 0 0
The number of subjects with treatment emergent adverse events
Timepoint [13] 0 0
48 weeks

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,VictoryWA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Princess Alexandra Hospital/ Translational Research Institute - Woolloongabba
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Austin Health - Heidelberg
Recruitment hospital [7] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 0 0
Monash Hospital - Clayton
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
Puerto Rico
State/province [10] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Altimmune, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Altimmune CTM
Address 0 0
Country 0 0
Phone 0 0
2406541450
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05989711