Symptomatic Non-erosive Gastroesophageal Reflux DiseasePhase 3NCT07752407
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
A Phase 3 study testing Vonoprazan in people with Symptomatic Non-erosive Gastroesophageal Reflux Disease, run by Phathom Pharmaceuticals, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Non-erosive Gastroesophageal Reflux Disease
- What is being tested?
- Vonoprazan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to 19 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Inclusion Criteria for Placebo-controlled Timed-assessment Period:
- 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.
Who cannot join
- 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.
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- 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.
- The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, ascorbic acid, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red ferric oxide). Skin testing may be performed according to local standard practice to confirm hypersensitivity.
- The participant has a history of alcohol abuse, illegal drug use, drug addiction, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report within the 12 months prior to screening. Participants must have a negative urine drug screen for non-prescribed medications at screening. Participants taking prescription drugs will be allowed. Occasional, recreational use of cannabis is allowed. However, participants with a cannabis use disorder (eg, frequent use, functional-social impairment, withdrawal symptoms) per the opinion of the Investigator should be excluded.
- The participant is taking any excluded medications or treatments listed in the protocol.
- If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study, or intending to donate ova during such time period.
- The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the Investigator, would confound the study results or compromise participant safety.
- The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Period.
- The participant has a history of malignancy (including mucosa-associated lymphoid tissue lymphoma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has recovered from cutaneous basal cell carcinoma or cervical carcinoma in situ).
- The participant has acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV-ribonucleic acid (RNA). However, participants who test positive for HCV antibody but negative for HCV-RNA are permitted to participate.
- The participant has moderate to severe hepatic impairment [Child-Pugh Class B and Child-Pugh Class C].
- The participant has severe renal impairment [estimated glomerular filtration rate <30 mL/min]).
- The participant has any of the following abnormal laboratory test values at the start of the Screening Period:
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except participants with Gilbert Syndrome).
- Creatinine levels: >2 mg/dL (>177 μmol/L).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Great Lakes Gastroenterology Research LLC
Mentor, Ohio, 44060
About this study
Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
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).
- Being tested
- Vonoprazan, Placebo
- Keywords
- GERD, symptomatic non-erosive gastroesophageal reflux disease, vonoprazan
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Oral tablet.
PlaceboDrug
Oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vonoprazan; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Treated Heartburn Episodes Achieving Complete Relief at 2 Hours and Sustained Relief for 24 Hours up to Week 12
Measured: 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
Measured: Up to Week 12
Percentage of Treated Heartburn Episodes Improved at 1 Hour With Sustained Relief for 24 Hours up to Week 12
Measured: Up to Week 12
Percentage of Treated Heartburn Episodes Improved at 2 Hours up to Week 12
Measured: Up to Week 12
Percentage of Treated Heartburn Episodes Improved at 1 Hour up to Week 12
Measured: 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
Measured: Up to Week 24
Percentage of Treated Heartburn Episodes Improved at 30 Minutes With Sustained Relief for 24 Hours up to Week 12
Measured: Up to Week 12
Percentage of Treated Heartburn Episodes Improved at 30 Minutes up to Week 12
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start25 Sep 2026
- Primary completion20 Oct 2027 (estimated)
- Study completion19 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Non-erosive Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phathom Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752407
- Sponsor's protocol ID
- NERD-302
- Status last verified
- Oct 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
- ClinicalTrials.gov ID
- NCT07752407
- Acronym / sponsor ID
- NERD-302
- Keywords
- GERD, symptomatic non-erosive gastroesophageal reflux disease, vonoprazan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Phathom Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 19 Jan 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan 10 mg | Experimental | Drug: VonoprazanParticipants 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. |
| Placebo | Placebo comparator | Drug: Vonoprazan, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (28 listed)
- 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:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VonoprazanOral tablet. | Drug | Placebo, Vonoprazan 10 mg |
| PlaceboOral tablet. | Drug | Placebo |
Primary outcome
Percentage of Treated Heartburn Episodes Achieving Complete Relief at 2 Hours and Sustained Relief for 24 Hours up to Week 12
Time frame: Up to Week 12
7 secondary outcomes
Percentage of Treated Heartburn Episodes Improved at 2 Hours With Sustained Relief for 24 Hours up to Week 12
Time frame: Up to Week 12
Percentage of Treated Heartburn Episodes Improved at 1 Hour With Sustained Relief for 24 Hours up to Week 12
Time frame: Up to Week 12
Percentage of Treated Heartburn Episodes Improved at 2 Hours up to Week 12
Time frame: Up to Week 12
Percentage of Treated Heartburn Episodes Improved at 1 Hour up to Week 12
Time frame: 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
Time frame: Up to Week 24
Percentage of Treated Heartburn Episodes Improved at 30 Minutes With Sustained Relief for 24 Hours up to Week 12
Time frame: Up to Week 12
Percentage of Treated Heartburn Episodes Improved at 30 Minutes up to Week 12
Time frame: Up to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vonoprazan in people with Symptomatic Non-erosive Gastroesophageal Reflux Disease, run by Phathom Pharmaceuticals, Inc. at 1 site in United States.
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 12 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 7 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 1 site in United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phathom Medical Information (1-888-775-7426, medicalinformation@phathompharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Treated Heartburn Episodes Achieving Complete Relief at 2 Hours and Sustained Relief for 24 Hours up to Week 12 (time frame: Up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.