NCT05989711Phase 2Completed

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

Study sponsor: Altimmune, Inc. · ALT

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Primary completion2025-11-25Actual
Enrollment · participants212Actual
Source updated2026-05-18Last update listed in the registry record
Version history

Changes to this trial

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· 2 fields changed

Primary outcomes · main study measures

Text edit · unverified significance
− Previous value

measure: 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; measure: 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)

+ Updated value

measure: 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; measure: 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); measure: Incidence of Treatment Emergent Adverse Events

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Primary completion date

Recorded edit
− Previous value

2025-04-29

+ Updated value

2025-11-25

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· 3 fields changed

Participant count type

Recorded edit
− Previous value

Estimated

+ Updated value

Actual

Enrollment · participant count

Recorded edit
− Previous value

count: 190; type: ESTIMATED

+ Updated value

count: 212; type: ACTUAL

Recruitment status

Recorded edit
− Previous value

Active not recruiting

+ Updated value

Completed

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· 1 field changed

Primary completion date

Recorded edit
− Previous value

2025-02-28

+ Updated value

2025-04-29

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