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GERD drug BLI5100 passes Year-Long safety check

NCT ID NCT05890001

Disease control Sponsor: Braintree Laboratories Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checked the safety of taking BLI5100 daily for up to 12 months in 400 adults with gastroesophageal reflux disease (GERD). Participants had either non-erosive reflux disease or healed erosive esophagitis. The main goal was to track any side effects. This is a disease control study, not a cure, as GERD typically requires ongoing management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

400 people

The number who actually took part.

Started

Apr 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have completed the BLI5100-301 or BLI5100-302 study with no serious AE (SAE) related to study drug and no major Protocol Deviations; 2. Able to understand and comply with the protocol requirements; 3. Willing and able to provide written informed consent at Screening; 4. Is a female of non-childbearing potential, or If a female of childbearing potential, agrees to use an acceptable form of birth control and avoid egg donation from the Screening Visit until 6 months after the last dose of study drug; 5. If a male, agrees to use an acceptable form of birth control from the Screening Visit until 3 months after the last dose of study drug; 6. If a male, agrees to abstain from sperm donation through 3 months after administration of the last dose of study drug; 7. Have documented healed EE (BLI5100-301 study patients only). Exclusion Criteria: 1. History of alcoholism, or substance abuse/addiction in the year before enrollment in the BLI5100-301 and BLI5100-302 studies; * Note: Patients on prescribed opioids are eligible to participate if they have been on a stable dose for the duration of the BLI5100-301 and BLI5100-302 studies. * Note: Retesting of a positive urine drug screen requires Medical Monitor approval. Positive urine drug screen for all drugs will require verification of prescription for the positive tested substance. 2. A diagnosis of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder is exclusionary, unless the patient is asymptomatic and well-controlled. Stable treatment, including non-medical therapy, is preferred, but minor adjustments can be made and should be consulted with the Medical Monitor; 3. Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for the duration of the BLI5100-301 and BLI5100-302 studies; 4. Requirement of persistent (\>3 times per week for \>30 days) use of non-steroidal anti-inflammatory drugs (NSAIDs) during the course of the study; o Note: Low-dose (≤100 mg/day) aspirin is allowed provided that it has been used for prophylaxis prior to study participation. 5. If a female, is pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose of study drug; 6. Abnormal laboratory results with clinical relevance at Screening as follows: * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase level of ≥2 × upper limit of normal (ULN); * Total bilirubin level of ≥2 × ULN, unless Gilbert's syndrome is confirmed when direct bilirubin is ≤0.3 mg/dL; * Estimated glomerular filtration rate \<30 mL/min. * Note: A lab value obtained during the Screening period may be retested once with Medical Monitor approval. 7. Abnormal ECG of clinical significance; 8. Involvement in another clinical study (other than BLI5100-301 and BLI5100-302 studies) within 4 weeks of initiation of study drug; 9. Any other clinically relevant condition that would confound study endpoints or adversely affect patient compliance with the study procedures in the medical judgment of the Investigator or Medical Monitor based on previous medical history or findings on Screening assessments.

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Conditions

The condition(s) this trial relates to.

esophagitis gastroesophageal reflux disease Non-Erosive Reflux Disease peptic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erosive esophagitis Non-erosive reflux disease

Contacts and locations

Locations

  • Research Site 01

    Gurnee, Illinois, 60031, United States

  • Research Site 02

    Oak Lawn, Illinois, 60453, United States

  • Research Site 05

    Palmetto Bay, Florida, 33157, United States

  • Research Site 06

    Las Vegas, Nevada, 89106, United States

  • Research Site 07

    Great Neck, New York, 11023, United States

  • Research Site 10

    Huntington Park, California, 90255, United States

  • Research Site 100

    Bellaire, Texas, 77401, United States

  • Research Site 103

    Nashville, Tennessee, 37211, United States

  • Research Site 108

    Cooper City, Florida, 33024, United States

  • Research Site 109

    Mentor, Ohio, 44060, United States

  • Research Site 11

    Sunrise, Florida, 33351, United States

  • Research Site 110

    Westlake, Ohio, 44145, United States

  • Research Site 111

    Chesterfield, Missouri, 63005, United States

  • Research Site 117

    North Little Rock, Arkansas, 72117, United States

  • Research Site 12

    Marrero, Louisiana, 70072, United States

  • Research Site 13

    Santa Ana, California, 92704, United States

  • Research Site 16

    South Ogden, Utah, 84405, United States

  • Research Site 17

    New Port Richey, Florida, 34653, United States

  • Research Site 20

    Columbus, Ohio, 43213, United States

  • Research Site 21

    San Antonio, Texas, 78249, United States

  • Research Site 22

    San Antonio, Texas, 78209, United States

  • Research Site 23

    Maitland, Florida, 32751, United States

  • Research Site 24

    Huntsville, Alabama, 35801, United States

  • Research Site 26

    San Antonio, Texas, 78229, United States

  • Research Site 27

    Tucson, Arizona, 85712, United States

  • Research Site 28

    Hartsdale, New York, 10530, United States

  • Research Site 29

    Lewisville, Texas, 75057, United States

  • Research Site 30

    Red Oak, Texas, 75154, United States

  • Research Site 32

    Pearland, Texas, 77584, United States

  • Research Site 34

    New Orleans, Louisiana, 70127, United States

  • Research Site 35

    Brooklyn, New York, 11235, United States

  • Research Site 38

    Miami, Florida, 33134, United States

  • Research Site 40

    Rochester, New York, 14609, United States

  • Research Site 41

    Santa Maria, California, 93458, United States

  • Research Site 42

    Miami Lakes, Florida, 33014, United States

  • Research Site 43

    Miami, Florida, 33136, United States

  • Research Site 45

    Houma, Louisiana, 70363, United States

  • Research Site 46

    Viera, Florida, 32940, United States

  • Research Site 48

    Metairie, Louisiana, 70006, United States

  • Research Site 49

    New York, New York, 10033, United States

  • Research Site 54

    Los Angeles, California, 90057, United States

  • Research Site 55

    La Mesa, California, 91942, United States

  • Research Site 59

    Sandy Springs, Georgia, 30328, United States

  • Research Site 60

    Nashville, Tennessee, 37203, United States

  • Research Site 62

    Phoenix, Arizona, 85018, United States

  • Research Site 64

    Reno, Nevada, 89511, United States

  • Research Site 65

    Sandy City, Utah, 84092, United States

  • Research Site 67

    Miami, Florida, 33155, United States

  • Research Site 71

    Miami, Florida, 33186, United States

  • Research Site 72

    Los Angeles, California, 90017, United States

  • Research Site 75

    Fayetteville, North Carolina, 28304, United States

  • Research Site 78

    Homestead, Florida, 33030, United States

  • Research Site 87

    Little Rock, Arkansas, 72211, United States

  • Research Site 88

    Columbus, Ohio, 43215, United States

  • Research Site 90

    Ocoee, Florida, 34761, United States

  • Research Site 91

    Doral, Florida, 33172, United States

  • Research Site 92

    Miami, Florida, 33173, United States

  • Research Site 94

    Chula Vista, California, 91910, United States

  • Research Site 98

    Dallas, Texas, 75230, United States

  • Research Site 99

    Forney, Texas, 75126, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.