Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH (PERFORMA)
26. august 2026 oppdatert av: Altimmune, Inc.
A Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects With Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
1800
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Shaheen Tomah, MD
- Telefonnummer: 440 240-654-1450
- E-post: stomah@altimmune.com
Studiesteder
-
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Arkansas
-
North Little Rock, Arkansas, Forente stater, 72117
- Rekruttering
- Altimmune Clinical Study Site
-
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California
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Fountain Valley, California, Forente stater, 92708
- Rekruttering
- Altimmune Clinical Study Site
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Fresno, California, Forente stater, 93720
- Rekruttering
- Altimmune Clinical Study Site
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Gardena, California, Forente stater, 90247
- Rekruttering
- Altimmune Clinical Study Site
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Long Beach, California, Forente stater, 90815
- Rekruttering
- Altimmune Clinical Study Site
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Florida
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Miami, Florida, Forente stater, 33173
- Rekruttering
- Altimmune Clinical Study Site
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Ocala, Florida, Forente stater, 34471
- Rekruttering
- Altimmune Clinical Study Site
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Ohio
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Springboro, Ohio, Forente stater, 45066
- Rekruttering
- Altimmune Clinical Study Site
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Westlake, Ohio, Forente stater, 44145
- Rekruttering
- Altimmune Clinical Study Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
All subjects:
- No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable)
- Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2
- Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome
- Subject agrees to have liver biopsy(ies) as required per protocol
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:
- Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C
- Uncontrolled T2D or clinically significant persistent hyperglycemia
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Placebo SC Injection
|
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Eksperimentell: Pemvidutid 2,4 mg
|
Pemvidutide SC Injection
|
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Eksperimentell: Pemvidutide 1.8 mg
|
Pemvidutide SC Injection
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Outcome Event
Tidsramme: Baseline through end of study (approximately Month 60)
|
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
|
Baseline through end of study (approximately Month 60)
|
|
Histological Response: MASH resolution
Tidsramme: Baseline through Week 52
|
Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network [CRN] classification) without worsening of fibrosis
|
Baseline through Week 52
|
|
Histological Response: Fibrosis improvement
Tidsramme: Baseline through Week 52
|
Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH
|
Baseline through Week 52
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: Baseline through Week 52
|
Baseline through Week 52
|
|
HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis
Tidsramme: Baseline through Week 52
|
Baseline through Week 52
|
|
Anthropometric parameters: Relative (%) change from baseline in body weight (kg)
Tidsramme: Baseline through End of Study (approximately Month 60)
|
Baseline through End of Study (approximately Month 60)
|
|
Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2)
Tidsramme: Baseline through End of Study (approximately Month 60)
|
Baseline through End of Study (approximately Month 60)
|
|
Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm)
Tidsramme: Baseline through End of Study (approximately Month 60)
|
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)
Tidsramme: Baseline through End of Study (approximately Month 60)
|
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
Tidsramme: Baseline through End of Study (approximately Month 60)
|
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
Tidsramme: Baseline through End of Study (approximately Month 60)
|
Baseline through End of Study (approximately Month 60)
|
|
HRQoL: Change from baseline in core symptoms of MASH on the NASH-CHECK questionnaire.
Tidsramme: Baseline through End of Study (approximately Month 60)
|
Baseline through End of Study (approximately Month 60)
|
|
HRQoL: Change from baseline in Short-form 36 (SF-36) summary scores.
Tidsramme: Baseline through End of Study (approximately Month 60)
|
Baseline through End of Study (approximately Month 60)
|
|
HRQoL: Change from baseline in Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH) domain scores.
Tidsramme: Baseline through End of Study (approximately Month 60)
|
Baseline through End of Study (approximately Month 60)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. juli 2026
Primær fullføring (Antatt)
1. desember 2028
Studiet fullført (Antatt)
1. desember 2032
Datoer for studieregistrering
Først innsendt
14. august 2026
Først innsendt som oppfylte QC-kriteriene
26. august 2026
Først lagt ut (Faktiske)
31. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- ALT-801-301
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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