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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Gastroparesis, Idiopathic Gastroparesis

In brief

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.

Key facts

Study ID

NCT04303195

Run by

Neurogastrx, Inc.

People needed

161

Starts

2020-08-01

Expected to finish

2023-02-25

Last updated by the study team

2025-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• G & L Research, LLC — Foley, Alabama, United States
• East View Medical Research — Mobile, Alabama, United States
• Phoenix Medical Group — Peoria, Arizona, United States
• Phoenix Clinical LLC — Phoenix, Arizona, United States
• Del Sol Research Management — Tucson, Arizona, United States
• Preferred Research Partners — Little Rock, Arkansas, United States
• GW Research, Inc — Chula Vista, California, United States
• Precision Research Institute, LLC — Chula Vista, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Diagnamics Inc. — Encinitas, California, United States
• Paragon Rx Clinical, Inc — Garden Grove, California, United States
• United Clinical Research — Irvine, California, United States
• Prime Care Clinical Rsearch — Laguna Hills, California, United States
• Torrance Clinical Research Institute, Inc. — Lomita, California, United States
• Angel City Research — Los Angeles, California, United States
• United Clinical Research — Murrieta, California, United States
• Diabetes Medical Center of California — Northridge, California, United States
• Precision Research Institute — San Diego, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Innovative Research of West Florida — Clearwater, Florida, United States
• Innovation Medical Group, LLC. — Fort Lauderdale, Florida, United States
• ENCORE Borland-Grover Clinical Research — Jacksonville, Florida, United States
• ClinCloud, LLC — Maitland, Florida, United States
• Verus Clinical Research, Corp — Miami, Florida, United States
• Digestive Health Specialists — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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