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Avexitide for Treatment of Post-Bariatric Hypoglycemia

(LUCIDITY)

Sponsored by Amylyx Pharmaceuticals Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Oct 9, 2025

Phase

Clinical Trial

Sponsor

Amylyx Pharmaceuticals Inc.

Enrollment Target

75

Start Date

Apr 2025

๐Ÿ“Š
1 of 75 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

AVX-001 (LUCIDITY) is a Phase 3 study to evaluate avexitide compared to placebo in participants with post bariatric hypoglycemia (PBH) related to Roux-en-Y gastric bypass (RYGB). The study will assess avexitide compared to placebo for safety and efficacy, measured by reduction of hypoglycemic events.

Who Can Participate

Inclusion Criteria

Able to provide written informed consent and understand the purpose and risks of the study
Willing and able to adhere to study requirements, including the use of the study-provided CGM device, SMBG device, and eDiary device as well as the other study evaluations and procedures.
Is male or female, at least 18 years of age (inclusive) at the time of consent.
Body mass index (BMI) of up to 40 kg/m2 and has stable body weight-i.e., not varying by \>5% for at least 2 months prior to Screening
Has undergone documented RYGB performed โ‰ฅ12 months prior to Screening.
Has clinical diagnosis of PBH-defined as history of recurrent hypoglycemia with onset after surgery and having ruled out other causes of hypoglycemia as per Investigator judgment.
Has recurrent hypoglycemia, as demonstrated by experiencing at least 3 discrete hypoglycemic episodes during the 3-week study Run-in period.
Must agree to consistently follow the dietary management guidance and to maint

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

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

75 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Amylyx Pharmaceuticals Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Stanford

California

Location available
View Stanford location page
RECRUITING

Aurora

Colorado

Location available
View Aurora location page
RECRUITING

Jacksonville

Florida

Location available
View Jacksonville location page
RECRUITING

Port Charlotte

Florida

Location available
View Port Charlotte location page
RECRUITING

Lawrenceville

Georgia

Location available
View Lawrenceville location page
RECRUITING

Topeka

Kansas

Location available
View Topeka location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

New Hyde Park

New York

Location available
View New Hyde Park location page

๐Ÿ“ And 12 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.

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Looking for Post-Bariatric Hypoglycemia Treatment in Stanford?

Join others in California exploring innovative treatment options through clinical research

Post-Bariatric Hypoglycemia Treatment Options in Stanford, California

If you're searching for Post-Bariatric Hypoglycemia treatment in Stanford, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Stanford, Aurora, Jacksonville 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 Post-Bariatric Hypoglycemia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 75 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Post-Bariatric Hypoglycemia?

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 Post-Bariatric Hypoglycemia

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 Post-Bariatric Hypoglycemia 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: NCT06747468. 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.