A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks

NCT07752407 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: NERD-302
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective is to assess the efficacy of vonoprazan (10 mg as needed) compared to placebo (as needed) in relief of episodic heartburn at 2 hours that is sustained for 24 hours over 12 weeks of treatment in participants with non-erosive gastroesophageal reflux disease (GERD).

Conditions

Symptomatic Non-erosive Gastroesophageal Reflux Disease

Keywords

GERD; symptomatic non-erosive gastroesophageal reflux disease; vonoprazan

Outcome Measures

Primary Outcomes (1)

• Percentage of Treated Heartburn Episodes Achieving Complete Relief at 2 Hours and Sustained Relief for 24 Hours up to Week 12

  Up to Week 12

Secondary Outcomes (7)

• Percentage of Treated Heartburn Episodes Improved at 2 Hours With Sustained Relief for 24 Hours up to Week 12

  Up to Week 12

• Percentage of Treated Heartburn Episodes Improved at 1 Hour With Sustained Relief for 24 Hours up to Week 12

  Up to Week 12

• Percentage of Treated Heartburn Episodes Improved at 2 Hours up to Week 12

  Up to Week 12

• Percentage of Treated Heartburn Episodes Improved at 1 Hour up to Week 12

  Up to Week 12

• Percentage of Treated Heartburn Episodes Achieving Complete Relief at 2 Hours and Sustained Relief for 24 hours up to Week 24

  Up to Week 24

Study Arms (2)

Vonoprazan 10 mg

EXPERIMENTAL

Participants will be administered open-label vonoprazan 10 mg once daily (QD) to be taken orally for 4 weeks during the 4-week run-in period. Participants will be administered vonoprazan 10 mg to be taken orally as needed at the onset of each heartburn episode (maximum of once in a 24-hour period) during the 12-week placebo-controlled timed assessment period and the subsequent 12-week placebo-controlled extension period.

Drug: Vonoprazan

Placebo

PLACEBO COMPARATOR

Participants will be administered open-label vonoprazan 10 mg QD to be taken orally for 4 weeks during the 4-week run-in period. Participants will be administered placebo to be taken orally as needed at the onset of each heartburn episode (maximum of once in a 24-hour period) during the 12-week placebo-controlled timed assessment period and the subsequent 12-week placebo-controlled extension period.

Drug: Vonoprazan; Drug: Placebo

Interventions

Vonoprazan DRUG

Oral tablet.

Placebo; Vonoprazan 10 mg

Placebo DRUG

Oral tablet.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is ≥18 years of age at the time of informed consent signing.
• In the opinion of the Investigator or Sub-investigators, the participant is capable of understanding and complying with protocol requirements, including compliance with the electronic diary.
• The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side effects. The participant has the ability to cooperate with the Investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
• The participant has a diagnosis of non-erosive GERD with heartburn as the participant's predominant symptom prior to the Screening Period as documented in the medical history and/or as assessed and documented by the Investigator (ie, medical records or other study related documents).
• History of onset of heartburn at least 6 months prior to the Screening Period.
• Heartburn reported on average 4 or more days per week and 4 or more days during the last 7 days of the Screening Period as recorded in the electronic diary.
• A female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug as detailed in the protocol.
• The participant completes the Run-In Period, during which the participant was at least 80% compliant with open-label study drug.
• The participant has stable disease, ie, no heartburn on the last 7 days of the Run-In Period.
• The participant continues to fulfill all eligibility criteria for the Run-In Period except heartburn reported on average 4 or more days per week and 4 or more days during the last 7 days of the Screening Period as recorded in the electronic diary.
• Participant completes at least 80% of diary entries during the Run-In Period and completes at least 6 of 7 (86%) diary entries over the last 7 days of the Run-In Period.

You may not qualify if:

• The participant has endoscopically confirmed erosive esophagitis (EE) during the Screening Period or was diagnosed with EE within 2 weeks prior to the Screening Period.
• The participant has uncontrolled irritable bowel syndrome (IBS) or has had a flare of IBS requiring therapy within the prior 6 months.
• The participant has a history of or is suspected of having:
• Functional heartburn, as described in the Rome V criteria.
• Functional dyspepsia, as described in the Rome V criteria.
• The participant has endoscopic Barrett's esophagus (\>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
• The participant tests positive for H. pylori infection during the Screening Period, after ≥ 4 weeks free from antibiotics and bismuth and ≥ 2 weeks free from proton pump inhibitors (PPIs), potassium-competitive acid blockers (PCABs), and histamine-2 receptor antagonists (H2RAs).
• The participant has any other clinically significant 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 (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) or hiatal hernia are eligible to participate.
• The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
• The participant has had gastric or duodenal ulcer(s) within 4 weeks before the first dose of study drug.
• The participant requires or is expected to require use of prescription or non-prescription PPIs, PCABs, or H2RAs throughout the study.
• The participant has received any investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period or has ever received vonoprazan in a clinical trial (including participation in Study NERD-201 \[NCT04799158\] or NERD-301 \[NCT05195528\]). A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
• The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
• The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to the Screening Period.
• The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.

Sponsors & Collaborators

• Phathom Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Phathom Medical Information

CONTACT

1-888-775-7426; medicalinformation@phathompharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Run-in period vonoprazan administration will be open-label. Placebo-controlled timed assessment period and placebo-controlled extension period will be double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): September 25, 2026
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): January 19, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share