Linaprazan Glurate vs Lansoprazole for Acid Reflux

Not yet recruiting at 99 trial locations

Overseen By Kajsa Larsson, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cinclus Pharma Holding AB

Must not be taking: Antibiotics, Bismuth drugs

Disqualifiers: HP infection, Cardiovascular, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if linaprazan glurate is more effective than the commonly used drug lansoprazole in healing and reducing symptoms of erosive esophagitis (damage to the esophagus) caused by GERD. Researchers will assess the safety of linaprazan glurate, its impact on heartburn, and whether its effectiveness varies with blood concentration or participants' genes. Individuals with confirmed esophageal damage from GERD, who have not recently received treatment for Helicobacter pylori infection, may be suitable for this study. Participants will take medication daily for up to 8 weeks and undergo regular health checks, including endoscopies and symptom questionnaires. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you've taken antibiotics or bismuth-containing drugs in the past 6 weeks, or if you've been treated with lansoprazole within 2 months before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that linaprazan glurate is generally safe. In earlier studies, patients tolerated it well and experienced high healing rates after four weeks of treatment. These studies suggest that linaprazan glurate is usually well-tolerated, with few side effects reported, indicating it may be safe to use.

Lansoprazole, already approved for treating acid reflux, is also known for its safety. It has been used for many years, and its side effects are well-known and usually mild.

In this trial, both treatments aim to reduce heartburn symptoms and heal damage to the esophagus. Evidence supports the safety of both linaprazan glurate and lansoprazole for treating acid reflux. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Linaprazan Glurate because it offers a potential new approach to treating acid reflux. Unlike standard treatments like lansoprazole, which primarily block acid production, Linaprazan Glurate works by targeting stomach acid secretion differently. This new mechanism could mean more effective relief for patients who don’t respond well to existing proton pump inhibitors (PPIs). Additionally, the flexibility in dosing—either once or twice daily—may improve patient adherence and convenience.

What evidence suggests that this trial's treatments could be effective for GERD?

This trial will compare Linaprazan Glurate with Lansoprazole for treating acid reflux. Studies have shown that Linaprazan Glurate, which participants in this trial may receive, effectively heals erosive esophagitis, a condition caused by GERD. One study found that 80% of patients who took Linaprazan Glurate experienced improvement, compared to 69% of those who took Lansoprazole, another treatment option in this trial. This suggests that Linaprazan Glurate might be more effective at healing the esophagus. Additionally, Linaprazan Glurate is generally well-tolerated, meaning it usually doesn't cause serious side effects. However, it hasn't always been more effective than other treatments when used long-term. Overall, early research is promising for Linaprazan Glurate, especially for short-term use. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with erosive esophagitis due to GERD, confirmed by endoscopy. It's not suitable for those with active Helicobacter pylori infection, recent HP treatment, or recent use of antibiotics or bismuth drugs.

Inclusion Criteria

The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any study-related assessments/procedures

The participant is willing and able to comply with all aspects of the protocol (including endoscopies, PK sampling, tablet and capsule swallowing, electronic device completion, etc.)

My GERD has caused esophagitis, confirmed by an endoscopy.

Exclusion Criteria

I don't have any major health issues that could risk my safety in the study or affect its results.

I have not had an HP infection or taken antibiotics in the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Linaprazan glurate or Lansoprazole for 8 weeks, with endoscopies at the beginning and after 4 weeks, and possibly at 8 weeks if healing is not observed.

8 weeks

Multiple visits for endoscopies and health monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including health checks and symptom questionnaires.

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lansoprazole
• Linaprazan Glurate

Trial Overview The study compares the effectiveness and safety of linaprazan glurate (50 mg once or twice daily) against lansoprazole (30 mg daily) in healing EE from GERD. It's a randomized, double-blind trial where neither participants nor researchers know who receives which treatment.

How Is the Trial Designed?

Group I: Group 2: Linaprazan glurate 50 mg QD Experimental Treatment 1 Intervention

Group II: Group 1: Linaprazan glurate 50 mg BID Experimental Treatment 1 Intervention

Group III: Group 3: Lansoprazole 30 mg QD Active Control 1 Intervention

Who Is Running the Clinical Trial?

Cinclus Pharma Holding AB

Lead Sponsor

Trials

2

Recruited

110+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12013784/

Clinical Trial: Dose‐Finding Study of Linaprazan Glurate, A ... Linaprazan glurate demonstrated high 4-week healing rates compared to lansoprazole, with a good safety profile, supporting its further development.

2. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1636523/full

Pharmacological characterization of linaprazan glurate ... However, linaprazan has failed to demonstrate superior efficacy to existing PPIs, especially regarding long-term use and control of nocturnal ...

3. ddw.digitellinc.com ddw.digitellinc.com/p/s/linaprazan-glurate-is-highly-effective-in-treating-moderate-to-severe-erosive-esophagitis-a-double-blind-randomized-dose-finding-study-2599

LINAPRAZAN GLURATE IS HIGHLY EFFECTIVE IN ... A high healing rate was seen after 4 weeks of LG treatment in the overall C/D cohort, with the highest healing rate seen for 75 mg. LG was generally well- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07037875

NCT07037875 | A Study Comparing the Effect and Safety ... Researchers will also evaluate whether linaprazan glurate: Reduces heartburn symptoms more effectively than lansoprazole; Is safe and well tolerated, based on ...

5. cincluspharma.com cincluspharma.com/our-science/clinical-development/

Clinical Development With Promising Results For all patients treated with linaprazan glurate, the mean healing rate was 80% compared to 69% in the lansoprazole treated group. For patients with milder ...

6. cincluspharma.com cincluspharma.com/media/in-the-spotlight/a-doctor-s-perspective-on-linaprazan-glurate-s-unique-potential/

A Doctor's perspective on linaprazan glurate's unique ... Short-term data on linaprazan glurate indicate a strong safety profile, making it suitable for acute therapy and healing for all stages of ...

7. firstwordpharma.com firstwordpharma.com/story/5671496

Cinclus Pharma announces positive topline results from ... For all patients treated with linaprazan glurate, the mean healing rate was 80% compared to 69% in the lansoprazole treated group. For patients ...