New GERD drug aims to keep esophagus healed, but trial never started
NCT ID NCT07313774
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to see if a new drug called linaprazan glurate could keep the esophagus healed in people with GERD-related erosive esophagitis, compared to an existing drug (lansoprazole). Participants would have taken daily pills for up to 52 weeks and had regular camera exams of their throat. However, the trial was withdrawn before any participants were enrolled.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: An individual who has participated in a preceding linaprazan glurate healing trial will be asked to participate in this maintenance trial if the following criteria apply: 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures. 2. The participant has a healed EE as assessed by central review of endoscopic examination either from the last regular visit in a preceding phase 3 healing trial OR from the Run-in Period to the present maintenance trial. 3. The participant is willing and able to comply with all aspects of the protocol (including endoscopies, tablet and capsule swallowing, electronic device \[e-device\] completion, etc.). Exclusion Criteria: An individual who has participated in a preceding linaprazan glurate phase 3 healing trial can be enrolled in this maintenance trial unless they meet any of the following exclusion criteria: 1. EE as graded from the endoscopy during the Run-in Period (only applicable for participants with previous endoscopy \>14 days before the last regular visit in the preceding healing trial). 2. Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett's esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture.\* \*Note: Participants with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate, unless history of dilatation within 3 months of the Run-in Period. 3. Significant noncompliance with protocol-specified procedures or treatment in the preceding healing trial as judged by the Investigator. 4. Adverse event (AE) resulting in premature discontinuation of IP in the preceding healing trial. 5. History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, neurological disease or disorder, or psychiatric diagnosis which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the trial results or the participant's ability to participate in the trial. The following examples are conditions that would exclude the participant from participating: 1. History of myocardial infarction/ acute coronary syndrome within 3 months prior to the M0 visit. 2. History of ventricular arrhythmia or implanted cardioverter defibrillator 3. Symptomatic congestive heart failure (New York Heart Association \[NYHA\] class 3-4) 4. Family history of/ diagnosis of hereditary arrhythmia syndrome
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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