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NCT07009860RECRUITINGIRB Ready

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

Sponsored by Altimmune, Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 100 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Male or female ages 18 to 75 years, inclusive 2. Overweight or obesity, defined as BMI โ‰ฅ 25 kg/m2 3. History of alcohol misuse for the prior 3 years, with an alcohol intake โ‰ฅ 50 grams per day for males and โ‰ฅ 40 grams per day for females on average in the past year 4. Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive

Exclusion Criteria

Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score โ‰ฅ 10 at screening and/or prior to randomization 2. History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year 3. History of seizures related to alcohol within the past year 4. History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the Investigator for at least 6 months prior to screening and cleared by the Medical Monitor

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

100 participants

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Age Range

18 Years - 75 Years

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Gender

ALL

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Sponsor

Altimmune, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Peoria

Arizona

Location available
View Peoria location page
NOT_YET_RECRUITING

Tucson

Arizona

Location available
View Tucson location page
RECRUITING

North Little Rock

Arkansas

Location available
View North Little Rock location page
NOT_YET_RECRUITING

Fresno

California

Location available
View Fresno location page
NOT_YET_RECRUITING

La Jolla

California

Location available
View La Jolla location page
NOT_YET_RECRUITING

Pasadena

California

Location available
View Pasadena location page
NOT_YET_RECRUITING

Englewood

Colorado

Location available
View Englewood location page
NOT_YET_RECRUITING

Bradenton

Florida

Location available
View Bradenton location page
NOT_YET_RECRUITING

Doral

Florida

Location available
View Doral location page

๐Ÿ“ And 25 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Alcohol-Associated Liver Disease Treatment in Peoria?

Join others in Arizona exploring innovative treatment options through clinical research

Alcohol-Associated Liver Disease Treatment Options in Peoria, Arizona

If you're searching for Alcohol-Associated Liver Disease treatment in Peoria, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Peoria, Tucson, North Little Rock and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Alcohol-Associated Liver Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Alcohol-Associated Liver Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Alcohol-Associated Liver Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Alcohol-Associated Liver Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07009860. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.