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Diabetic GastroparesisPhase 2NCT04303195

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

A Phase 2 study testing NG101 in people with Diabetic Gastroparesis and Idiopathic Gastroparesis, run by Neurogastrx, Inc. at 83 sites in United States.

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 purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NG101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
161 participants
Where
83 sitesUnited States
Study dates
1 Aug 2020to 25 Feb 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Adult patients with diabetic or idiopathic gastroparesis
  • Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain)
  • Documented evidence of no mechanical obstruction
  • Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test

Who cannot join

  • Uncontrolled diabetes (defined as HgbA1c > 10%)
  • Severe postural symptoms or evidence of unexplained recurrent dizziness
  • Participant has received and tolerated domperidone and showed no notable symptomatic improvement in gastroparesis symptoms
  • Participant has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.
  • Participant engages in daily recreational use of marijuana
  • Prolactin levels > 2 x ULN

Trial locations and contacts

83 sites in 1 country.

83 sites in 1 country

United States83 sites

  • Lovelace Respiratory Rsearch Institute

    Albuquerque, New Mexico, 87108

  • Agile Clinical Research Trials, LLC

    Atlanta, Georgia, 30328

  • Avant Research Associates

    Austin, Texas, 78704

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Dayton Gastroenterology Inc.

    Beavercreek, Ohio, 45440

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Javara Research

    Charlotte, North Carolina, 28210

  • Claude Mandel Medical Center

    Chicago, Illinois, 60617

  • GW Research, Inc

    Chula Vista, California, 91910

  • Precision Research Institute, LLC

    Chula Vista, California, 91910

  • Hometown Urgent Care and Research

    Cincinnati, Ohio, 45215

  • Innovative Research of West Florida

    Clearwater, Florida, 33756

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80920

  • Hometown Urgent Care and Research

    Columbus, Ohio, 43214

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45424

  • IResearch Atlanta LLC

    Decatur, Georgia, 30030

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Digestive Health Specialists

    Dothan, Alabama, 36305

  • Draelos Metabolic Center

    Edmond, Oklahoma, 73034

  • Texas Tech University Health Sciences Center

    El Paso, Texas, 79905

  • Diagnamics Inc.

    Encinitas, California, 92024

  • Medisphere Medical Research Center LLC

    Evansville, Indiana, 47714

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • G & L Research, LLC

    Foley, Alabama, 36535

  • Innovation Medical Group, LLC.

    Fort Lauderdale, Florida, 33316

  • Paragon Rx Clinical, Inc

    Garden Grove, California, 92840

  • Triad Clinical Trials

    Greensboro, North Carolina, 27410

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Indiana University Hospital

    Indianapolis, Indiana, 46202

  • United Clinical Research

    Irvine, California, 92618

  • Transsouth Healthcare PC

    Jackson, Tennessee, 38305

  • ENCORE Borland-Grover Clinical Research

    Jacksonville, Florida, 32256

  • Sante Clinical Research

    Kerville, Texas, 78028

  • Prime Care Clinical Rsearch

    Laguna Hills, California, 92653

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Advanced Biomedical Research of America

    Las Vegas, Nevada, 89123

  • Digestive Disease Specialists

    Las Vegas, Nevada, 89128

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Torrance Clinical Research Institute, Inc.

    Lomita, California, 90717

  • Angel City Research

    Los Angeles, California, 90010

  • University of Louisville

    Louisville, Kentucky, 40202

  • ClinCloud, LLC

    Maitland, Florida, 32751

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Tandem Clinical Research GI, LLC

    Marrero, Louisiana, 70072

  • Rio Grande Gastroenterology

    McAllen, Texas, 78503

  • Verus Clinical Research, Corp

    Miami, Florida, 33125

  • APF Research, LLC

    Miami, Florida, 33134

  • Panax Clinical Research

    Miami, Florida, 33155-1691

  • International Research Associates LLC

    Miami, Florida, 33156

  • PharmaSouth Research

    Miami, Florida, 33175

  • KLEO Health & Research

    Missoula, Montana, 59803

  • East View Medical Research

    Mobile, Alabama, 36606

  • United Clinical Research

    Murrieta, California, 92563

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Synexus Clinical Research

    New York, New York, 10017

  • Tandem Clinical Research GI, LLC

    New York, New York, 10033

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Diabetes Medical Center of California

    Northridge, California, 91325

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • DM Clinical Research Solutions PC

    Pearland, Texas, 77584

  • Phoenix Medical Group

    Peoria, Arizona, 85381

  • Phoenix Clinical LLC

    Phoenix, Arizona, 85014-2151

  • AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg

    Pinellas Park, Florida, 33781

  • AES - DRS - Synexus Clinical Research US, Inc. - Plano

    Plano, Texas, 75093-8157

  • Sun Research

    San Antonio, Texas, 78215

  • Southern Star Research Institute

    San Antonio, Texas, 78229

  • Synexus Clinical Research

    San Antonio, Texas, 78229

  • Precision Research Institute

    San Diego, California, 92114

  • West Glen GI

    Shawnee Mission, Kansas, 66217

  • Velocity Clinical Research Spokane

    Spokane, Washington, 99202

  • Avita Clinical Research

    Tampa, Florida, 33613

  • Horizon Clinical Research- Tomball

    Tomball, Texas, 77375

  • Kansas Medical Clinic

    Topeka, Kansas, 66606

  • Del Sol Research Management

    Tucson, Arizona, 85715

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Clinical Trials of America

    West Monroe, Louisiana, 71291

  • West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis

The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment.

Read the detailed description

This is a randomized, double-blind, parallel-group , placebo-controlled, multicenter US-based study to evaluate the safety and efficacy of 3 dose levels of NG101 (Metopimazine mesylate) compared with placebo in participants with diabetic or idiopathic gastroparesis.

The study will enroll approximately 140 participants. Following the Screening Period, there is a 2-week Pretreatment Period during which participants will complete an electronic daily diary. Participants eligible for the clinical study will be randomly assigned (in a 1:1:1:1 ratio) to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. All participants will be asked to take one capsule 30 minutes before a meal 3 times a day and 30 minutes before bedtime for a total of 4 capsules daily (QID). The total duration of the study for each participant will be approximately 20 weeks.

Being tested
NG101, Placebo

What participants receive

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

  • NG101Drug

    Also called metopimazine mesylate

    Capsules

  • PlaceboDrug

    Capsules

Study groups in NCT04303195
Study groupRoleWhat they receive
NG101 - 5 mgExperimentalNG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Receives: Drug: NG101
NG101 - 10 mgExperimentalNG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Receives: Drug: NG101
NG101 - 20 mgExperimentalNG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Receives: Drug: NG101
PlaceboPlacebo comparatorPlacebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline of Nausea Severity Score

    Change from Baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD). Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 12

Secondary outcomes (6)

  1. Change From Baseline in Early Satiety Severity Score

    Change from baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD) for early satiety severity score.

    Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 12

  2. Change From Baseline in Postprandial Fullness Severity Score

    Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.

    Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 12

  3. Change From Baseline in Abdominal Pain Severity Score

    Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.

    Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 12

  4. Change From Baseline in Discrete Episodes of Vomiting

    Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for the number of discrete episodes of vomiting.

    Participants were asked to record the number of episodes of vomiting in the past 24 hours. Each episode counts as "1". A negative change from baseline indicates improvement.

    Measured: Baseline to Week 12

  5. Change From Baseline in 3-symptom Severity Score

    Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 3-symptom severity score.

    Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week, the 3-symptom severity score is the average of the mean daily scores of nausea, early satiety, and postprandial fullness severity scores. A negative change from baseline indicates improvement.

    Measured: Baseline to Week 12

  6. Change From Baseline in 4-symptom Severity Score

    Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 4-symptom severity score.

    Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week, the 4-symptom severity score is the average of the mean daily scores of nausea, early satiety, postprandial fullness, and abdominal pain severity scores. A negative change from baseline indicates improvement

    Measured: Baseline to Week 12

Timeline

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

  1. First posted10 Mar 2020
  2. Study start1 Aug 2020
  3. Primary completion25 Feb 2023
  4. Study completion25 Feb 2023

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04303195
Sponsor's protocol ID
NG101-201
Status last verified
Aug 2025
First submitted
12 Feb 2020
Last updated
28 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Loesch J, Hamza E, Pasricha PJ, Nee J, Cline M, MacDougall J, Simons M, Brown JT, Garg S, Hoscheit M, Gabbard S, De Colle C, Lembo A. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Metopimazine Mesylate (NG101) in Participants With Gastroparesis. Am J Gastroenterol. 2026 Feb 1;121(2):534-544. doi: 10.14309/ajg.0000000000003534. Epub 2025 May 14.

    PubMed 40367443

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NG101 in people with Diabetic Gastroparesis and Idiopathic Gastroparesis, run by Neurogastrx, Inc. at 83 sites 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 4 inclusion and 6 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline of Nausea Severity Score (time frame: Baseline to Week 12). 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 NCT04303195, which also lists 1 linked publication.

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 28 Aug 2025.

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