IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT05989711
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
212 participants
INTERVENTIONAL
2023-07-27
2025-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pemvidutide 1.2 mg (n=38)
Pemvidutide
Administered by subcutaneous injection
Pemvidutide 1.8 mg (n=76)
Pemvidutide
Administered by subcutaneous injection
Placebo (n=76)
Placebo
Administered by subcutaneous injection
Interventions
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Pemvidutide
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Altimmune, Inc.
INDUSTRY
Responsible Party
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Locations
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Altimmune Clinical Study Site
Chandler, Arizona, United States
Altimmune Clinical Study Site
Peoria, Arizona, United States
Altimmune Clinical Study Site
Tucson, Arizona, United States
Altimmune Clinial Study Site
Tucson, Arizona, United States
Altimmune Clinical Study Site
North Hollywood, California, United States
Altimmune Clinical Study Site
Panorama City, California, United States
Altimmune Clinical Study Site
Englewood, Colorado, United States
Altimmune Clinical Study Site
Bradenton, Florida, United States
Altimmune Clinical Study Site
Fort Myers, Florida, United States
Altimmune Clinical Study Site
Hialeah Gardens, Florida, United States
Altimmune Clinical Study Site
Miami Lakes, Florida, United States
Altimmune Clinical Study Site
Port Orange, Florida, United States
Altimmune Clinical Study Site
Sarasota, Florida, United States
Altimmune Clinical Study Site
West Palm Beach, Florida, United States
Altimmune Clinical Study Site
Dalton, Georgia, United States
Altimmune Clinical Study Site
Marietta, Georgia, United States
Altimmune Clinical Study Site
Bastrop, Louisiana, United States
Altimmune Clinical Study Site
Shreveport, Louisiana, United States
Altimmune Clinical Study Site
Clarksville, Tennessee, United States
Altimmune Clinical Study Site
Germantown, Tennessee, United States
Altimmune Clinical Study Site
Austin, Texas, United States
Altimmune Clinical Study Site
Bellaire, Texas, United States
Altimmune Clinical Study Site
Edinburg, Texas, United States
Altimmune Clinical Study Site
Edinburg, Texas, United States
Altimmune Clinical Study Site
Georgetown, Texas, United States
Altimmune Clinical Study Site
Houston, Texas, United States
Altimmune Clinical Study Site
San Antonio, Texas, United States
Altimmune Clinical Study Site
San Antonio, Texas, United States
Altimmune Clinical Study Site
West Jordan, Utah, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital/ Translational Research Institute
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Box Hill Hospital
Box Hill, Victory, Australia
Monash Hospital
Clayton, Victory, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Altimmune Clinical Study Site
San Juan, , Puerto Rico
Countries
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References
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Noureddin M, Harrison SA, Loomba R, Alkhouri N, Chalasani N, Sheikh MY, Tomah S, Gutierrez JA, Urbina S, Suschak JJ, Brown R, Odili O, Yang J, Keeton S, Neff G, Mena E, Roberts MS, Browne SK, Harris MS. Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study. Lancet. 2025 Dec 6;406(10520):2644-2655. doi: 10.1016/S0140-6736(25)02114-2. Epub 2025 Nov 11.
Other Identifiers
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ALT- 801-203
Identifier Type: -
Identifier Source: org_study_id