Phase 2
N=161
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
Diabetic Gastroparesis · Idiopathic Gastroparesis
Bottom Line
View on ClinicalTrials.gov: NCT04303195 ↗Enrolled (actual)
161
Serious AEs
1.2%
Results posted
Aug 2025
Primary outcome: Primary: Change From Baseline of Nausea Severity Score — -3.55; -3.65; -3.43; -2.83 units on a scale — p=0.1350
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NG101 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neurogastrx, Inc.
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of Nausea Severity Score |
-3.55; -3.65; -3.43; -2.83 | 0.1350 |
| SECONDARY Change From Baseline in Early Satiety Severity Score |
-3.02; -3.23; -2.64; -2.89 | 0.7944 |
| SECONDARY Change From Baseline in Postprandial Fullness Severity Score |
-2.94; -2.96; -2.67; -2.87 | 0.8866 |
| SECONDARY Change From Baseline in Abdominal Pain Severity Score |
-2.65; -2.69; -2.19; -2.70 | 0.9034 |
| SECONDARY Change From Baseline in Discrete Episodes of Vomiting |
-0.42; -0.50; -0.40; -0.31 | 0.3567 |
| SECONDARY Change From Baseline in 3-symptom Severity Score |
-3.16; -3.28; -2.92; -2.85 | 0.5250 |
| SECONDARY Change From Baseline in 4-symptom Severity Score |
-3.04; -3.14; -2.74; -2.81 | 0.6009 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04303195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.