IMPACT

CompletedPhase 2

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

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)

Lead sponsor

Altimmune, Inc.

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

212

actual

Study population

MASH / NAFLD / liver fibrosis, Metabolic syndrome, Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoints

•MASH resolution, no fibrosis worsening•Fibrosis ≥1-stage improvement, no MASH worsening•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05989711

Org study IDALT- 801-203

Timeline

Milestones

Study start2023-07-27actual

Study first posted2023-08-14actual

Primary completion2025-11-25actual

Study completion2025-11-25actual

Last update posted2026-05-18actual

Assets

Investigational agents

Pemvidutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisMetabolic syndromeObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

MASH / liver

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Relative (%) change in body weight

Time frame:24 weeks and 48 weeks

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in HbA1c (%)

Time frame:24 weeks and 48 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in glucose (mg/dL)

Time frame:24 weeks and 48 weeks

change from baseline, improvement

MASH / liver

8 endpoints

Primary/protocol endpoint

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

MASH resolution, no fibrosis worsening

categorical status, improvement

SNOMED 442685003

Primary/protocol endpoint

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

Fibrosis ≥1-stage improvement, no MASH worsening

categorical status, improvement

Secondary/protocol endpoint

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

MASH resolution + fibrosis improvement

categorical status, improvement

Secondary/protocol endpoint

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

Time frame:24 weeks and 48 weeks

MRI-PDFF, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:24 weeks and 48 weeks

change from baseline, improvement

Secondary/protocol endpoint

Absolute change in alanine aminotransferase (ALT)

Time frame:24 weeks and 48 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Absolute change in Enhanced Liver Fibrosis (ELF) score

Time frame:24 weeks and 48 weeks

ELF score, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute change in Fibroscan-AST (FAST) score

Time frame:24 weeks and 48 weeks

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)

Time frame:24 weeks and 48 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in systolic and diastolic blood pressure (mmHg)

Time frame:24 weeks and 48 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in heart rate (beats per minute)

Time frame:24 weeks and 48 weeks

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Incidence of Treatment Emergent Adverse Events

Time frame:52 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

The number of subjects with treatment emergent adverse events

Time frame:48 weeks

Treatment-emergent AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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 (London, England)2025 Dec 6PMID41237796doi:10.1016/S0140-6736(25)02114-2via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.