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

NCT05989711 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALT- 801-203
• Study Type: interventional
• Target: 212
• Locations: 3 countries
• Sites: 40

Brief Summary

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

Conditions

Non-Alcoholic Steatohepatitis (NASH)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks

  24 weeks

• Relative change (%) in liver fat content by MRI-PDFF

  24 weeks and 48 weeks

• Absolute change in MRI-based corrected T1 (cT1) imaging

  24 weeks and 48 weeks

• Absolute change in alanine aminotransferase (ALT)

  24 weeks and 48 weeks

• Absolute change in Enhanced Liver Fibrosis (ELF) score

  24 weeks and 48 weeks

Study Arms (3)

Pemvidutide 1.2 mg (n=38)

EXPERIMENTAL

Drug: Pemvidutide

Pemvidutide 1.8 mg (n=76)

EXPERIMENTAL

Drug: Pemvidutide

Placebo (n=76)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pemvidutide DRUG

Administered by subcutaneous injection

Pemvidutide 1.2 mg (n=38); Pemvidutide 1.8 mg (n=76)

Placebo DRUG

Administered by subcutaneous injection

Placebo (n=76)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (40)

Altimmune Clinical Study Site

Chandler, Arizona, 85224, United States

Location

Altimmune Clinical Study Site

Peoria, Arizona, 85345, United States

Location

Altimmune Clinical Study Site

Tucson, Arizona, 85701, United States

Location

Altimmune Clinial Study Site

Tucson, Arizona, 85704, United States

Location

Altimmune Clinical Study Site

North Hollywood, California, 33019, United States

Location

Altimmune Clinical Study Site

Panorama City, California, 91402, United States

Location

Altimmune Clinical Study Site

Englewood, Colorado, 80110, United States

Location

Altimmune Clinical Study Site

Bradenton, Florida, 34201, United States

Location

Altimmune Clinical Study Site

Fort Myers, Florida, 33912, United States

Location

Altimmune Clinical Study Site

Hialeah Gardens, Florida, 33018, United States

Location

Altimmune Clinical Study Site

Miami Lakes, Florida, 33014, United States

Location

Altimmune Clinical Study Site

Port Orange, Florida, 32123, United States

Location

Altimmune Clinical Study Site

Sarasota, Florida, 34240, United States

Location

Altimmune Clinical Study Site

West Palm Beach, Florida, 33401, United States

Location

Altimmune Clinical Study Site

Dalton, Georgia, 30720, United States

Location

Altimmune Clinical Study Site

Marietta, Georgia, 30006, United States

Location

Altimmune Clinical Study Site

Bastrop, Louisiana, 78602, United States

Location

Altimmune Clinical Study Site

Shreveport, Louisiana, 71101, United States

Location

Altimmune Clinical Study Site

Clarksville, Tennessee, 37040, United States

Location

Altimmune Clinical Study Site

Germantown, Tennessee, 38138, United States

Location

Altimmune Clinical Study Site

Austin, Texas, 73301, United States

Location

Altimmune Clinical Study Site

Bellaire, Texas, 77401, United States

Location

Altimmune Clinical Study Site

Edinburg, Texas, 78539, United States

Location

Altimmune Clinical Study Site

Edinburg, Texas, 78540, United States

Location

Altimmune Clinical Study Site

Georgetown, Texas, 78626, United States

Location

Altimmune Clinical Study Site

Houston, Texas, 77036, United States

Location

Altimmune Clinical Study Site

San Antonio, Texas, 78201, United States

Location

Altimmune Clinical Study Site

San Antonio, Texas, 78204, United States

Location

Altimmune Clinical Study Site

West Jordan, Utah, 84081, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Princess Alexandra Hospital/ Translational Research Institute

Woolloongabba, Queensland, 4102, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Box Hill Hospital

Box Hill, Victory, 3128, Australia

Location

Monash Hospital

Clayton, Victory, 3168, Australia

Location

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Altimmune Clinical Study Site

San Juan, 00901, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 41237796 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, Placebo-controlled

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 14, 2023
• Study Start: July 27, 2023
• Primary Completion: April 29, 2025
• Study Completion: November 25, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (29); PR (1); AU (10)