A Phase 3 interventional study of Pemvidutide and Placebo in Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Altimmune, Inc.. Recruiting at 9 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Altimmune, Inc. · Phase 3, Interventional, and Treatment
Phase 3, multicenter, multinational, 2-cohort, randomized, double-blind, placebo controlled, parallel-group pivotal study to evaluate the efficacy, safety, and clinical outcomes of pemvidutide treatment in subjects with noncirrhotic (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH). Participants will be assigned either to Cohort 1 based on screening histologic (liver biopsy) criteria or to Cohort 2 based on non-invasive test criteria.
662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 60 across 431 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Altimmune, Inc. is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 4 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All subjects:
Cohort 1 - Histologic diagnosis of F2/F3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening
Cohort 2 - Presumed F2/F3 MASH based on noninvasive testing
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pemvidutide
Drug: Pemvidutide
Other: Placebo
Pemvidutide SC Injection
Placebo SC Injection
Clinical Outcome Event
Time to first occurrence of any of the following events through the end of the study: Histologic progression to cirrhosis (F4) on liver biopsy; Liver related events; Liver transplantation; or Death due to any cause
Time frame: Baseline through end of study (approximately Month 60)
Histological Response: MASH resolution
Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network \[CRN\] classification) without worsening of fibrosis
Time frame: Baseline through Week 52
Histological Response: Fibrosis improvement
Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH
Time frame: Baseline through Week 52
Histologic Response: Proportion of subjects achieving both MASH resolution (according to NASH CRN classification) without worsening of fibrosis and ≥ 1 stage improvement in liver fibrosis without worsening of MASH
Time frame: Baseline through Week 52
HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis
Time frame: Baseline through Week 52
Anthropometric parameters: Relative (%) change from baseline in body weight (kg)
Time frame: Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2)
Time frame: Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm)
Time frame: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in alanine aminotransferase (ALT; U/L)
Time frame: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Time frame: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Relative (%) change from baseline in vibration controlled transient elastography (VCTE; kPa) by Fibroscan
Time frame: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in core symptoms of MASH on the NASH-CHECK questionnaire.
Time frame: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in Short-form 36 (SF-36) summary scores.
Time frame: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH) domain scores.
Time frame: Baseline through End of Study (approximately Month 60)
Plan to share: Yes
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Studies of the drug tested here: Pemvidutide
Altimmune, Inc.