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RECRUITING Phase 2

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

NCT07009860 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD. * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Pemvidutide

Study Locations (20)

Florida

  • Altimmune Clinical Study Site — Bradenton
  • Altimmune Clinical Study Site — Doral
  • Altimmune Clinical Study Site — Doral
  • Altimmune Clinical Study Site — Fort Myers
  • Altimmune Clinical Study Site — Miami
  • Altimmune Clinical Study Site — Miami
  • Altimmune Clinical Study Site — Miami Lakes
  • Altimmune Clinical Study Site — Naples
  • Altimmune Clinical Study Site — Orlando
  • Altimmune Clinical Study Site — Port Orange

Arizona

  • Altimmune Clinical Study Site — Peoria
  • Altimmune Clinical Study Site — Tucson
  • Altimmune Clinical Study Site — Tuscon

California

  • Altimmune Clinical Study Site — Fresno
  • Altimmune Clinical Study Site — La Jolla
  • Altimmune Clinical Study Site — Pasadena

Arkansas

  • Altimmune Clinical Study Site — North Little Rock

Colorado

  • Altimmune Clinical Study Site — Englewood

Georgia

  • Altimmune Clinical Study Site — Atlanta

Indiana

  • Altimmune Clinical Study Site — Indianapolis

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2025-06-16
Est. Completion 2027-08-31
Phase Phase 2

Sponsor

Altimmune

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07009860

The ClinicalTrials.gov registry entry for NCT07009860 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Altimmune, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Alcohol Liver Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07009860 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07009860 about?

NCT07009860 is a clinical study titled "RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)". This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD. * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly

What is the current status of trial NCT07009860?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-06-16. Estimated completion is 2027-08-31.

What conditions does trial NCT07009860 study?

This clinical trial studies the following conditions: Alcohol Liver Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07009860?

The interventions under investigation include: Placebo (OTHER), Pemvidutide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07009860?

This trial is sponsored by Altimmune, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07009860 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial