InvestigationalMetabolic

Pemvidutide

Related names in cited records: ALT-801

A glucagon/GLP-1 receptor agonist candidate. This profile cites a completed ClinicalTrials.gov study record.

Citation markers ↗ open the public records supporting the adjacent statements.

Profile update · July 27, 2026

We rewrote the profile summary to describe the cited study record more directly. The cited source and status did not change. 1

This version supersedes public version 1.

Start here

The evidence at a glance

What is its status in the cited records?

Investigational. ClinicalTrials.gov lists Altimmune's IMPACT study as completed, last updated May 18, 2026.

Status sources checked through July 22, 2026. See status sources and coverage →

What do the reviewed human studies say?

Human evidence reviewed September 15, 2026 · Review version 1.

Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.

Two selected reports examine liver-fat changes during an extension study and histologic outcomes in a phase 2 trial. The extension continues an earlier participant cohort; it is not a separate randomized trial.

What the reviewed sources report

The extension reported liver-fat reductions among selected continuing participants. IMPACT met its MASH-resolution endpoint at 24 weeks but did not demonstrate its fibrosis-improvement endpoint. Longer-term clinical outcomes remain unestablished.

What remains unresolved?

  • How do the original trial and selected extension differ in participant retention and outcome analysis?
  • What do full reports establish about missing outcomes, sustained histologic changes and longer-term clinical events?

Read study designs, results, limitations, and sources →

Reviews summarize selected studies; their scope and limitations are shown above.

Research coverage and study families

Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.

Open machine-readable coverage and record decisions →

PubMed search

Scoped identity/name search for initial human evidence synthesis; other aliases and preclinical, extension and combination reports require separate eligibility decisions.

16 retrieved · 3 included · 13 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

"pemvidutide"[Title/Abstract] OR "alt 801"[Title/Abstract] OR "alt 801"[Title/Abstract]

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T13:07:38.377533+00:00 · HTTP 200 · SHA-256 240d2eb76a0e93ba470b3f93d37fe2b1e2d2f6cb2c7a4490e1dc3c8a391e9f16.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T13:05:28.022958+00:00 · HTTP 200 · SHA-256 7a8327935ada768478803dda6062b8cd9a79a5437c3da183658ba3fdca4093f2.

  • Open the source endpoint ↗

    Retrieved 2026-09-15T20:03:10.099913+00:00 · HTTP 200 · SHA-256 48268afc48ac1a4dd9aad5b04867a75332483aa9178cee91d2210916d1b0189f.

  • Registry comparison, additional aliases and references, and regulator reconciliation require separate checks.
  • Original phase 2 MASLD report PMID39002641 has a publisher correction whose full content remains unavailable; the corrected report is not summarized here.
  • The 24-week report identifies an extension of the earlier 12-week study; its NCT05292911 extension is grouped with parent NCT05006885. The three included reports still require full-text appraisal and correction reconciliation.
  • The modeling supplement cites a 2022 first-in-human presentation; that original presentation and its study-family relationship remain unappraised. Excluding this secondary analysis does not discard the citation lead.

Showing 16 of 16 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

  1. PubMed 41237796 — include: Primary human trial or extension report; the selected abstract establishes the trial identity, while full-text appraisal and registry history remain separate. Study families: NCT05989711.
  2. PubMed 41113119 — include: Primary human trial or extension report; the selected abstract establishes the trial identity, while full-text appraisal and registry history remain separate. The 24-week report follows completers of the original 12-week MASLD study; NCT05292911 is its extension registry. The parent and extension are retained as one study family. Study families: NCT05006885.
  3. PubMed 39002641 — include: Primary human trial or extension report; the selected abstract establishes the trial identity, while full-text appraisal and registry history remain separate. Study families: NCT05006885.
  4. PubMed 42529769 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
  5. PubMed 41879841 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
  6. PubMed 41696398 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
  7. PubMed 41661442 — exclude: Cross-species pharmacokinetic modeling reuses pemvidutide human data from a 2022 first-in-human presentation (supplement Table S1, page 5; reference 11, page 12). It is not an additional primary human-administration report. The presentation remains a citation lead, not a newly appraised trial.
    Full-text eligibility check · PMC13038672

    Read the source full text ↗ · sections Methods: The Dataset of Peptide Drug Pharmacokinetics, Data availability.

    Source supplementary files ↗

    • 40262_2025_1615_MOESM1_ESM.pdf · Table S1: pemvidutide human row (page 5), Reference 11 (page 12) · SHA-256 2b22d67fac8dd7e88b4cad561180e5f83ea9c83609b04ac584e6e163f0aad985.

    This reading establishes eligibility for this search; it is not a full appraisal of the study.

    Reviewed 2026-09-15; source SHA-256 c4ded6a9a4a4a2c98a1e749a9a47f519b6f7c4470675544bbfe80d5168947262.

  8. PubMed 41352959 — exclude: The author disclosure in the PubMed record explicitly identifies this article as a Comment. It discusses the phase 2b trial rather than reporting an additional primary human-administration study.

    Eligibility source ↗ · Conflict-of-interest statement: author identifies this as a Comment · read 2026-09-15.

  9. PubMed 41362110 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
  10. PubMed 40734920 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
  11. PubMed 40081498 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
  12. PubMed 40063921 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
  13. PubMed 39676791 — exclude: Secondary review, commentary or research overview; not a primary human-administration report for this molecule.
  14. PubMed 35461369 — exclude: Preclinical, genetic or mechanistic study; no primary administration of this molecule to people is reported in the inspected abstract.
  15. PubMed 21994418 — exclude: ALT-801 here refers to an oncology IL-2/T-cell-receptor fusion program or a multi-drug trial roundup, not the pemvidutide GLP-1/glucagon agonist.
  16. PubMed 20383346 — exclude: Multi-drug clinical-trial roundup; does not supply a primary report of pemvidutide administration.

FDA search

Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.

0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

Search terms, record decisions and remaining work

products.active_ingredients.name:"PEMVIDUTIDE"

Source retrievals and payload pins
  • Open the source endpoint ↗

    Retrieved 2026-09-15T11:10:23.854318+00:00 · HTTP 404 · SHA-256 57b1e7534d003e4246182162fd2469cdf038de39405056f44fc006715e5496da.

  • Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
  • This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.

Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

    EMA search

    Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.

    0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

    Search terms, record decisions and remaining work

    Case-insensitive word-boundary identity terms: ["Pemvidutide", "ALT-801"]

    Source retrievals and payload pins
    • Open the source endpoint ↗

      Retrieved 2026-09-15T08:34:22.905972+00:00 · HTTP 200 · SHA-256 a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729.

    • Document appraisal and national European sources remain open.
    • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

    Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

      EMA search

      Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.

      0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

      Search terms, record decisions and remaining work

      Case-insensitive word-boundary identity terms: ["Pemvidutide", "ALT-801"]

      Source retrievals and payload pins
      • Open the source endpoint ↗

        Retrieved 2026-09-15T08:34:29.167460+00:00 · HTTP 200 · SHA-256 c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439.

      • Document appraisal and national European sources remain open.
      • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

      Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

        EMA search

        Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.

        0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals

        Search terms, record decisions and remaining work

        Case-insensitive word-boundary identity terms: ["Pemvidutide", "ALT-801"]

        Source retrievals and payload pins
        • Open the source endpoint ↗

          Retrieved 2026-09-15T08:34:31.262344+00:00 · HTTP 200 · SHA-256 7448bf4e77e3345b3f3fbb7062c335d2302d8ea458a246bbe8256ce48aad2806.

        • Document appraisal and national European sources remain open.
        • Zero matches apply only to these feed fields and terms; orphan designation is not approval.

        Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

          ClinicalTrials.gov search

          ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.

          16 retrieved · 0 included · 0 excluded · 16 awaiting a decision · 0 full-text appraisals

          Search terms, record decisions and remaining work

          "Pemvidutide" OR "ALT-801"

          Source retrievals and payload pins
          • Open the source endpoint ↗

            Retrieved 2026-09-15T11:26:47.285429+00:00 · HTTP 200 · SHA-256 cd4726fd7528b41be9eff0acbee97162e9cafc07bf7dcd277ed360651fad6c4e.

          • Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
          • Other registries, unregistered studies and additional aliases remain outside this query.

          Showing 16 of 16 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.

          1. ClinicalTrials.gov NCT07009860 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          2. ClinicalTrials.gov NCT01670994 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          3. ClinicalTrials.gov NCT01326871 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          4. ClinicalTrials.gov NCT05295875 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          5. ClinicalTrials.gov NCT06987513 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          6. ClinicalTrials.gov NCT00496860 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          7. ClinicalTrials.gov NCT05292911 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          8. ClinicalTrials.gov NCT01029873 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          9. ClinicalTrials.gov NCT01478074 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          10. ClinicalTrials.gov NCT04972396 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          11. ClinicalTrials.gov NCT04561245 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          12. ClinicalTrials.gov NCT05134662 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          13. ClinicalTrials.gov NCT01625260 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          14. ClinicalTrials.gov NCT07795164 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          15. ClinicalTrials.gov NCT05006885 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          16. ClinicalTrials.gov NCT05989711 — not screened: Registry name-query match awaiting intervention identity, study-family linkage and results appraisal.
          Read the full Human Evidence Review

          Supervised synthesis

          What do selected human studies report about Pemvidutide?

          Manually reviewed September 15, 2026 · version 1

          Browse all Human Evidence Reviews · Open preserved synthesis version 1 →

          Two selected reports examine liver-fat changes during an extension study and histologic outcomes in a phase 2 trial. The extension continues an earlier participant cohort; it is not a separate randomized trial.12

          Bottom line from this bounded source set

          The extension reported liver-fat reductions among selected continuing participants. IMPACT met its MASH-resolution endpoint at 24 weeks but did not demonstrate its fibrosis-improvement endpoint. Longer-term clinical outcomes remain unestablished.12

          Reviewed study record

          MASLD extension

          Design

          Double-blind extension of a preceding randomized trial; NCT05292911.1

          Population

          64 participants from the earlier 94-participant study continued; this is not a new independently randomized cohort.1

          Outcomes reported

          At 24 weeks, reported relative liver-fat reductions were 56.3%, 75.2% and 76.4% in active groups versus 14.0% with placebo.1

          Limitations

          Selective extension participation can bias interpretation. MRI liver fat is not the same as histologic fibrosis improvement or patient-important liver outcomes.1

          Reviewed study record

          IMPACT: biopsy-confirmed MASH

          Design

          Randomized, double-blind, placebo-controlled phase 2 trial; NCT05989711; two coprimary histology endpoints at week 24.2

          Population

          212 participants with MASH and stage F2 or F3 fibrosis participated.2

          Outcomes reported

          The study met the endpoint of MASH resolution without worsening fibrosis, but did not meet the fibrosis-improvement endpoint without worsening MASH. Adverse events were reported in 78% and 81% of active groups versus 67% with placebo.2

          Limitations

          The abstract does not fully describe handling of missing biopsy outcomes. Longer follow-up was ongoing; a favorable disease-activity endpoint does not establish fibrosis benefit or fewer clinical events.2

          Reviewed source set

          1. PubMed · 41113119Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. ↗PubMed PMID 41113119 · EFetch XML reviewed 2026-09-15 · payload SHA-256 d02cc11ccdebbc2d2d7f2dcd803d72fac82dab958b1ca103096a9f2b94a061c5
            No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/j.jhepr.2025.101483. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
          2. PubMed · 41237796Safety 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. ↗PubMed PMID 41237796 · EFetch XML reviewed 2026-09-15 · payload SHA-256 dc020308c93198cfa3c4163c9eb9c575c301825253480a1bfa07d377614feda9
            No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/s0140-6736(25)02114-2. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
          Explore status sources, recent additions, and coverage gaps

          Living status brief

          What is the current status of Pemvidutide?

          Investigational. ClinicalTrials.gov lists Altimmune's IMPACT study as completed, last updated May 18, 2026.

          The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.

          Evidence present

          What records are connected here?

          Evidence lanes
          1
          Source years
          2
          Drugs@FDA applications
          0

          These are counts in PeptideScanner’s selected public collection, not measures of research quality, medical relevance, safety, or effectiveness.

          Coverage gaps

          What remains unknown or unsupported?

          PeptideScanner currently has no selected PubMed literature metadata records, regulatory records, and safety records connected to this profile. That is a collection gap, not evidence that no such records exist.

          PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.

          Explore the Evidence Map and record counts

          Evidence Map v1

          What kinds of records connect to Pemvidutide?

          Compare collection coverage →

          This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.

          6Selected dated records
          6Connected citations
          2Populated source years2025–2026
          1/4Record lanes present

          Registered human studies

          Trial composition

          4 of 6 selected trial records include at least one phase value; 4 of 6 include a status value in the retained structured contract.

          20 public history versions connect to 3 of these trial records across 4 submitted years. Open the record-history collection →

          PhasesPhase 2 2Phase 1 1Phase 3 1
          Status at observationCompleted 2Recruiting 2

          A phase value is unavailable here for 2 selected records; this is not counted as “no phase.”

          A status value is unavailable here for 2 selected records; this is not counted as a trial status.

          PubMed bibliography

          Publication composition

          0 of 0 selected PubMed records include attributed title, venue, publication date, and publication-type fields.

          Regulatory and publication surfaces

          What is structurally connected?

          Drugs@FDA applications
          0
          FDA Federal Register documents
          0
          DailyMed SPL versions
          0
          Canonical profile
          Published
          Profile structured data
          Published
          Linked dated records
          6

          Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.

          Profile publication history and record counts

          Research hub

          Explore the Pemvidutide evidence record

          Open all 6 records →
          6Dated records
          1Evidence type
          6Cited public sources
          2Source years

          Change ledger

          Recently changed for Pemvidutide

          Open all 7 events →

          PeptideScanner change dates and cited source dates stay separate. These entries report collection or version activity, not a ranking of importance.

          Record added

          ClinicalTrials.gov record NCT04561245

          PeptideScanner retained ClinicalTrials.gov record NCT04561245 at 2026-07-30T18:26:04.261Z. Its registry update date was 2025-06-24, and PeptideScanner's reviewed identity mapping was pemvidutide.

          PeptideScanner change date
          September 9, 2026
          Cited source date
          June 24, 2025
          Evidence lane
          Clinical trials
          Record added

          ClinicalTrials.gov record NCT07795164

          PeptideScanner retained ClinicalTrials.gov record NCT07795164 at 2026-09-09T19:17:17.076Z. Its registry update date was 2026-08-31, and PeptideScanner's reviewed identity mapping was pemvidutide.

          PeptideScanner change date
          September 9, 2026
          Cited source date
          August 31, 2026
          Evidence lane
          Clinical trials
          Record added

          ClinicalTrials.gov record NCT06987513

          PeptideScanner retained ClinicalTrials.gov record NCT06987513 at 2026-08-10T18:10:03.928Z. Its registry update date was 2026-07-31, and PeptideScanner's reviewed identity mapping was pemvidutide.

          PeptideScanner change date
          August 14, 2026
          Cited source date
          July 31, 2026
          Evidence lane
          Clinical trials

          Official-source collections

          Source records for Pemvidutide

          Open the full research atlas →

          Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.

          Evidence types

          Coverage by source year

          Selected records span June 24, 2025 to August 31, 2026.

          Continue exploring

          Profiles with overlapping source-year coverage

          Open the research atlas →

          These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.

          Glucagon2 shared source years308 dated records · 4 evidence typesSemaglutide2 shared source years237 dated records · 4 evidence typesLeuprolide2 shared source years215 dated records · 4 evidence typesTirzepatide2 shared source years169 dated records · 4 evidence types

          These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.

          Evidence summary

          What the cited records say

          ClinicalTrials.gov lists Altimmune's IMPACT study as completed, last updated May 18, 2026.

          This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.

          Cited context

          Related records

          Organizations named in cited records

          • Altimmune, Inc.

          Trial records

          Dated source history

          Updates connected to this profile

          Open the full cross-source timeline →
          1. Clinical trials

            ClinicalTrials.gov record NCT07795164

            PeptideScanner retained ClinicalTrials.gov record NCT07795164 at 2026-09-09T19:17:17.076Z. Its registry update date was 2026-08-31, and PeptideScanner's reviewed identity mapping was pemvidutide.

          2. Clinical trials

            ClinicalTrials.gov record NCT06987513

            PeptideScanner retained ClinicalTrials.gov record NCT06987513 at 2026-08-10T18:10:03.928Z. Its registry update date was 2026-07-31, and PeptideScanner's reviewed identity mapping was pemvidutide.

          3. Clinical trials

            ClinicalTrials.gov record NCT05989711

            PeptideScanner retained ClinicalTrials.gov record NCT05989711 at 2026-07-30T16:19:36.923Z. Its registry update date was 2026-05-18, and PeptideScanner's reviewed identity mapping was pemvidutide.

          4. Clinical trials

            Pemvidutide IMPACT study record updated

            ClinicalTrials.gov lists a completed Pemvidutide study sponsored by Altimmune, Inc.

          5. Clinical trials

            ClinicalTrials.gov record NCT07009860

            PeptideScanner retained ClinicalTrials.gov record NCT07009860 at 2026-07-30T16:22:22.335Z. Its registry update date was 2026-03-20, and PeptideScanner's reviewed identity mapping was pemvidutide.

          6. Clinical trials

            ClinicalTrials.gov record NCT04561245

            PeptideScanner retained ClinicalTrials.gov record NCT04561245 at 2026-07-30T18:26:04.261Z. Its registry update date was 2025-06-24, and PeptideScanner's reviewed identity mapping was pemvidutide.