A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis
1 other identifier
interventional
161
1 country
83
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2020
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2023
CompletedResults Posted
Study results publicly available
August 28, 2025
CompletedAugust 28, 2025
August 1, 2025
2.6 years
February 12, 2020
June 25, 2025
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
Baseline to Week 12
Secondary Outcomes (6)
Change From Baseline in Early Satiety Severity Score
Baseline to Week 12
Change From Baseline in Postprandial Fullness Severity Score
Baseline to Week 12
Change From Baseline in Abdominal Pain Severity Score
Baseline to Week 12
Change From Baseline in Discrete Episodes of Vomiting
Baseline to Week 12
Change From Baseline in 3-symptom Severity Score
Baseline to Week 12
- +1 more secondary outcomes
Study Arms (4)
NG101 - 5 mg
EXPERIMENTALNG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
NG101 - 10 mg
EXPERIMENTALNG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
NG101 - 20 mg
EXPERIMENTALNG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks
Placebo
PLACEBO COMPARATORPlacebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (83)
Digestive Health Specialists
Dothan, Alabama, 36305, United States
G & L Research, LLC
Foley, Alabama, 36535, United States
East View Medical Research
Mobile, Alabama, 36606, United States
Phoenix Medical Group
Peoria, Arizona, 85381, United States
Phoenix Clinical LLC
Phoenix, Arizona, 85014-2151, United States
Del Sol Research Management
Tucson, Arizona, 85715, United States
Preferred Research Partners
Little Rock, Arkansas, 72211, United States
GW Research, Inc
Chula Vista, California, 91910, United States
Precision Research Institute, LLC
Chula Vista, California, 91910, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
Diagnamics Inc.
Encinitas, California, 92024, United States
Paragon Rx Clinical, Inc
Garden Grove, California, 92840, United States
United Clinical Research
Irvine, California, 92618, United States
Prime Care Clinical Rsearch
Laguna Hills, California, 92653, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, 90717, United States
Angel City Research
Los Angeles, California, 90010, United States
United Clinical Research
Murrieta, California, 92563, United States
Diabetes Medical Center of California
Northridge, California, 91325, United States
Precision Research Institute
San Diego, California, 92114, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80920, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
Innovation Medical Group, LLC.
Fort Lauderdale, Florida, 33316, United States
ENCORE Borland-Grover Clinical Research
Jacksonville, Florida, 32256, United States
ClinCloud, LLC
Maitland, Florida, 32751, United States
Verus Clinical Research, Corp
Miami, Florida, 33125, United States
APF Research, LLC
Miami, Florida, 33134, United States
Panax Clinical Research
Miami, Florida, 33155-1691, United States
International Research Associates LLC
Miami, Florida, 33156, United States
PharmaSouth Research
Miami, Florida, 33175, United States
Sensible Healthcare
Ocoee, Florida, 34761, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 33157, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg
Pinellas Park, Florida, 33781, United States
Avita Clinical Research
Tampa, Florida, 33613, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328, United States
IResearch Atlanta LLC
Decatur, Georgia, 30030, United States
Claude Mandel Medical Center
Chicago, Illinois, 60617, United States
Medisphere Medical Research Center LLC
Evansville, Indiana, 47714, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
West Glen GI
Shawnee Mission, Kansas, 66217, United States
Kansas Medical Clinic
Topeka, Kansas, 66606, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, 70072, United States
Clinical Trials of America
West Monroe, Louisiana, 71291, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Aa Mrc Llc
Flint, Michigan, 48504, United States
West Michigan Clinical Research Center
Wyoming, Michigan, 49519, United States
KLEO Health & Research
Missoula, Montana, 59803, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Digestive Disease Specialists
Las Vegas, Nevada, 89128, United States
Lovelace Respiratory Rsearch Institute
Albuquerque, New Mexico, 87108, United States
Synexus Clinical Research
New York, New York, 10017, United States
Tandem Clinical Research GI, LLC
New York, New York, 10033, United States
Javara Research
Charlotte, North Carolina, 28210, United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304, United States
Triad Clinical Trials
Greensboro, North Carolina, 27410, United States
Carolina Digestive Diseases
Greenville, North Carolina, 27834, United States
Dayton Gastroenterology Inc.
Beavercreek, Ohio, 45440, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215, United States
Hometown Urgent Care and Research
Columbus, Ohio, 43214, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
Draelos Metabolic Center
Edmond, Oklahoma, 73034, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
Transsouth Healthcare PC
Jackson, Tennessee, 38305, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
Avant Research Associates
Austin, Texas, 78704, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
Biopharma Informatic, LLC
Houston, Texas, 77043, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Sante Clinical Research
Kerville, Texas, 78028, United States
Rio Grande Gastroenterology
McAllen, Texas, 78503, United States
DM Clinical Research Solutions PC
Pearland, Texas, 77584, United States
AES - DRS - Synexus Clinical Research US, Inc. - Plano
Plano, Texas, 75093-8157, United States
Sun Research
San Antonio, Texas, 78215, United States
Southern Star Research Institute
San Antonio, Texas, 78229, United States
Synexus Clinical Research
San Antonio, Texas, 78229, United States
Horizon Clinical Research- Tomball
Tomball, Texas, 77375, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Velocity Clinical Research Spokane
Spokane, Washington, 99202, United States
Related Publications (1)
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. 2025 May 14. doi: 10.14309/ajg.0000000000003534. Online ahead of print.
PMID: 40367443DERIVED
Results Point of Contact
- Title
- Chief Scientific Officer
- Organization
- Neurogastrx
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2020
First Posted
March 10, 2020
Study Start
August 1, 2020
Primary Completion
February 25, 2023
Study Completion
February 25, 2023
Last Updated
August 28, 2025
Results First Posted
August 28, 2025
Record last verified: 2025-08