AzTrials
AzTrials

GERD (Gastroesophageal Reflux Disease)Phase 3NCT07037875

A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD)

A Phase 3 study testing Linaprazan glurate 50 mg Twice Daily (BID), Linaprazan Glurate 50 mg Once Daily (QD) and Lansoprazole 30 mg Once Daily (QD) in people with GERD (Gastroesophageal Reflux Disease), run by Cinclus Pharma Holding AB at 87 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
GERD (Gastroesophageal Reflux Disease)
What is being tested?
Linaprazan glurate 50 mg Twice Daily (BID), Linaprazan Glurate 50 mg Once Daily (QD) and Lansoprazole 30 mg Once Daily (QD)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
523 participants
Where
87 sitesin 8 countries
Study dates
11 Sep 2025to 28 Sep 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any study-related assessments/procedures.
  • Male or female participants aged 18 to 80 years, inclusive, at the time of signing the ICF.
  • The participant is willing and able to comply with all aspects of the protocol (including endoscopies, PK sampling, tablet and capsule swallowing, electronic device [e-device] completion, etc.).
  • The participant has endoscopically confirmed EE due to GERD of LA grades A to D during the Screening Period as assessed in Central Review by an Independent Review Committee (IRC).

Who cannot join

  • Ongoing infection with HP or diagnosis and treatment of HP infection within 6 weeks of randomization OR any treatment with antibiotics or bismuth containing drugs within 6 weeks of randomization.
  • 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 study, or influence the study results or the participant's ability to participate in the study. The following examples are conditions that would exclude the patient from participating:
  • History of myocardial infarction/acute coronary syndrome within 3 months prior to Screening.
  • History of ventricular arrhythmia or implanted cardioverter defibrillator.
  • Symptomatic congestive heart failure (New York Heart Association class 3-4).
  • Family history of/diagnosis of hereditary arrhythmia syndrome.
Show all 16Show fewer
  • History of adult asthma that required intensive treatment in an emergency room.
  • History of malignancy of any organ system (other than completely treated localized basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or in situ cervical carcinoma), within the past 5 years.
  • 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*; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma.
  • Note: Patients 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 Screening.
  • History of any surgical or medical condition which might significantly alter the GERD status or the absorption, distribution, metabolism, or excretion of drugs. The Investigator is to be guided by evidence of any of the following: history of major GI surgery such as gastrectomy, gastroenterostomy, any bariatric surgery, bowel resection, or transjugular intrahepatic portosystemic shunt. Nissen fundoplication is not exclusionary as long as the patient is eligible according to other criteria.
  • Known severe atrophic gastritis as assessed from medical history or upper endoscopy during Screening.
  • Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
  • History of treatment course with lansoprazole within 2 months prior to Screening.
  • Current peptic ulcer.
  • Body mass index (BMI) ≤ 18 and ≥ 40 kg/m² at Screening.

Trial locations and contacts

87 sites in 8 countries.

87 sites in 8 countries

Poland27 sites

  • NZOZ Specialist Gastrology Centre GASTROMED

    Bialystok, 15-322

  • "MEDIS" Medical Center

    Bydgoszcz, 85-229

  • NZOZ KERmed Medical Centre

    Bydgoszcz, 85-231

  • CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

    Bydgoszcz, 85-794

  • Klara Medical Center

    Częstochowa, 42-202

  • St. John Paul 2nd Municipal Hospital in Elblag, Department of Internal Diseases

    Elblag, 82-300

  • Synexus Polska Sp. z o.o. Branch in Gdansk

    Gdansk, 80-382

  • Synexus Polska Sp. z o.o. Branch in Katowice

    Katowice, 40-040

  • "Vita Longa" Non-Public Healthcare Facility, Limited Liability Company

    Katowice, 40-748

  • Independent Public Healthcare Facility University Hospital in Krakow, NSSU Endoscopy Department

    Krakow, 30-688

  • FutureMeds Krakow

    Krakow, 31-501

  • Independent Public Healthcare Facility, Norbert Barlicki University Teaching Hospital No. 1 of the Medical University in Lodz, Clinical Department of General Gastroenterology and Oncology

    Lodz, 90-153

  • Hospital of Brothers Hospitallers of Saint John of God In Lodz, Endoscopy Lab

    Lodz, 93-357

  • Oswiecim Clinical Trial Centre

    Oświęcim, 32-600

  • EMC Medical Institute Joint Stock Company, CERTUS Private Healthcare Facility Hospital No. 1, CERTUS Private Healthcare Facility Ambulatories

    Poznan, 60-309

  • Synexus Polska Sp. z o.o. Branch in Poznan

    Poznan, 60-702

  • Saint Wojciech Hospital, Gastroenterology Clinic

    Poznan, 61-144

  • New health-CK, Kieltucki and partners g.p.

    Staszów, 28-200

  • Gastromed Sp. z o.o. (LLC)

    Torun, 87-100

  • FutureMeds Warsaw Center

    Warsaw, 00-215

  • Therapia Nova

    Warsaw, 01-595

  • ETG Warszawa

    Warsaw, 02-677

  • Futuremeds Targowek

    Warsaw, 03-291

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501

  • Medical Centre Oporow

    Wroclaw, 52-416

  • FutureMeds Wroclaw

    Wroclaw, 53-673

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

Bulgaria17 sites

  • Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD

    Dupnitsa, Dupnitsa, 2600

  • Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD

    Gorna Oryahovitsa, Gorna Oryahovitsa, 5100

  • Medical Center Hera

    Kyustendil, 2500

  • University Multiprofile Hospital for Active Treatment "Sveta Marina"

    Pleven, 5800

  • Medical Center "Futuremeds"

    Plovdiv, 4000

  • Multiprofile Hospital for Active Treatment "Sveti Panteleymon"

    Plovdiv, 4000

  • Diagnosis - Consulting Centre 1

    Sliven, Sliven

  • Medical Center "Orange"

    Sofia, Sofia City Province, 1343

  • Multiprofile Hospital for Active Treatment - "Vita"

    Sofia, Sofia City Province, 1407

  • Diagnostic and Consulting Center Alexandrovska

    Sofia, Sofia City Province, 1431

  • Diagnostic Consultative Center - Focus-5

    Sofia, Sofia City Province, 1463

  • Medical Center Hera

    Sofia, Sofia City Province, 1510

  • University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"

    Sofia, Sofia City Province, 1527

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov

    Sofia, Sofia City Province, 1606

  • 20th Diagnostic Consultancy Center

    Sofia, Sofia City Province, 1618

  • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Gastroenterology

    Sofia, 1431

  • First Private Hospital Vratsa

    Vratsa, 3000

Other trials in Bulgaria

Georgia14 sites

  • Khozrevanidze's Clinic

    Batumi, 6000

  • LTD Health

    Batumi, 6010

  • JSC Georgian Clinics

    Kutaisi, 4600

  • LTD Aversi Clinic

    Marneuli, 3000

  • LTD Krol Medical Corporation

    Tbilisi, 0101

  • The New Hospitals

    Tbilisi, 0114

  • Israeli - Georgian Medical Research Clinic Healthycore LLC

    Tbilisi, 0119

  • Janmrtelobis Sakhli LLC

    Tbilisi, 0144

  • LLC Geo Hospitals

    Tbilisi, 0144

  • K. Eristavi National Center of Experimental and Clinical Surgery JSC

    Tbilisi, 0159

  • LTD Aversi Clinic

    Tbilisi, 0160

  • LEPL The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0178

  • LTD The First Medical Center

    Tbilisi, 0180

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

    Tbilisi, 0180

Other trials in Georgia

Hungary11 sites

  • Bekes County Central Hospital Dr. Rethy Pal Member Hospital, 4th Department of Internal Medicine - Gastroenterology - Hepatology

    Békéscsaba, H-5600

  • G1 Institute

    Budapest, 1036

  • Clinexpert Ltd. Budapest

    Budapest, H-1033

  • Obuda Healthcare Center Ltd.

    Budapest, H-1036

  • Synexus Hungary Ltd.

    Budapest, H-1036

  • Central Hospital of Northern Pest - Military Hospital, Department of Gastroenterology

    Budapest, H-1062

  • Main Railway Outpatient Clinic Debrecen, Department of Gastroenterology

    Debrecen, H-4025

  • Heves County Markhot Ferenc Teaching Hospital and Clinic, Department of General and Vascular Surgery

    Eger, H-3300

  • University of Szeged, Department of Internal Medicine- Western Site

    Szeged, H-6720

  • Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I

    Székesfehérvár, H-8000

  • Javorszky Odon Hospital Vac, Department of Gastroenterology

    Vác, H-2600

Other trials in Hungary

Czechia7 sites

  • Military Hospital Brno, Internal Department

    Brno, Brno, 615 00

  • SurGal Clinic s.r.o.

    Brno, 602 00

  • University Hospital Brno

    Brno, 625 00

  • PreventaMed s.r.o.

    Olomouc, 779 00

  • Gastromedic s.r.o.

    Pardubice, 53003

  • Hospital Prachatice a.s.

    Prachatice, 38301

  • Endohope Morava s.r.o.

    Zábřeh, 78901

Other trials in Czechia

Germany4 sites

  • Medical Care Unit Dachau

    Dachau, Bavaria, 85221

  • EUGASTRO GmbH

    Leipzig, Saxony, 04103

  • Diakonie Hospital

    Mannheim, Baden-Wurttemberg, 68163

  • Clinic for Internal Medicine Munich-Sued

    Munich, Bavaria, 81379

Other trials in Germany

Serbia4 sites

  • Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje"

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • General Hospital Leskovac

    Leskovac, 16000

  • General Hospital Uzice

    Užice, 31000

Other trials in Serbia

Romania3 sites

  • Colentina Clinical Hospital, Department of Gastroenterology

    Bucharest, 020125

  • Cluj Napoca County Emergency Clinical Hospital, Internal Medicine III

    Cluj-Napoca, 400006

  • TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy

    Cluj-Napoca, 400061

Other trials in Romania

About this study

Official title: A Randomized, Phase 3, Double-blind, Double-dummy, Active Comparator-controlled Multicenter Study to Evaluate the Efficacy and Safety of 2 Doses of Linaprazan Glurate Compared to Lansoprazole in 4 or 8 Weeks Healing in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) of Los Angeles (LA) Grades A to D

The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate:

  • Reduces heartburn symptoms more effectively than lansoprazole
  • Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate)
  • Causes any side effects during treatment
  • Has different effects depending on how much of the drug is in the blood
  • Works differently depending on participants' genes
Read more

Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks.

The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups (about 167 people in each group):

  • Linaprazan glurate 50 mg twice a day
  • Linaprazan glurate 50 mg once a day
  • Lansoprazole 30 mg once a day

Everyone will take 2 tablets and 1 capsule by mouth daily for 8 weeks. Some tablets or capsules will be placebos (look like medicine but contain no active drug). Participants will:

  • Undergo an endoscopy in the beginning and after 4 weeks of treatment
  • If healing is not observed, another endoscopy may be done at 8 weeks
  • During the procedure, doctors will use a thin, flexible tube with a camera to look at the esophagus and take small tissue samples (biopsies)
  • Have blood and urine tests at clinic visits to check overall health
  • Receive electrocardiograms (ECGs) to monitor heart function
  • Complete daily questionnaires on an electronic device about symptoms and experiences
Being tested
Linaprazan glurate 50 mg Twice Daily (BID), Linaprazan Glurate 50 mg Once Daily (QD), Lansoprazole 30 mg Once Daily (QD)
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Linaprazan glurate 50 mg Twice Daily (BID)Drug

    Participants in this group will receive a total daily dose of 100 mg of linaprazan glurate, administered as 50 mg in the morning and 50 mg in the evening.

    In the morning, they take one 50 mg linaprazan glurate tablet along with a placebo capsule that matches the appearance of the lansoprazole capsule. In the evening, they take another 50 mg linaprazan glurate tablet, without any additional placebo.

  • Linaprazan Glurate 50 mg Once Daily (QD)Drug

    Participants in this group will receive a total daily dose of 50 mg of linaprazan glurate, taken once daily in the morning.

    In the morning, they take one 50 mg linaprazan glurate tablet along with a placebo capsule that mimics the lansoprazole capsule. In the evening, they take a placebo tablet that mimics the appearance of the linaprazan glurate tablet.

  • Lansoprazole 30 mg Once Daily (QD)Drug

    Participants in this group will receive a total daily dose of 30 mg of lansoprazole, taken once daily in the morning.

    In the morning, they take one 30 mg lansoprazole capsule along with a placebo tablet that mimics the linaprazan glurate tablet. In the evening, they take another placebo tablet resembling linaprazan glurate.

Study groups in NCT07037875
Study groupRoleWhat they receive
Group 1: Linaprazan glurate 50 mg BIDExperimentalNot described
Receives: Drug: Linaprazan glurate 50 mg Twice Daily (BID)
Group 2: Linaprazan glurate 50 mg QDExperimentalNot described
Receives: Drug: Linaprazan Glurate 50 mg Once Daily (QD)
Group 3: Lansoprazole 30 mg QDActive comparatorNot described
Receives: Drug: Lansoprazole 30 mg Once Daily (QD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D.

    Measured: From enrollment to the end of treatment at 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start11 Sep 2025
  3. Primary completion28 Sep 2026
  4. Study completion28 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
523 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07037875
Sponsor's protocol ID
CX842A2301
Other IDs
2024-518714-31-00, UTN U1111-1315-2237
Status last verified
Oct 2026
First submitted
17 Jun 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linaprazan glurate 50 mg Twice Daily (BID), Linaprazan Glurate 50 mg Once Daily (QD) and Lansoprazole 30 mg Once Daily (QD) in people with GERD (Gastroesophageal Reflux Disease), run by Cinclus Pharma Holding AB at 87 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Poland, Bulgaria, Georgia, Hungary, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D. (time frame: From enrollment to the end of treatment at 4 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07037875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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