Trial · NCT04303195

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

NCT04303195, Phase 2, Completed, Neurogastrx, Inc.; results first posted 2025-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis. Trials, record NCT04303195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04303195

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis
NCT number: NCT04303195
Status: Completed
Phases: Phase 2
Enrollment: 161 participants, actual
Lead sponsor: Neurogastrx, Inc.
Conditions: Diabetic Gastroparesis, Idiopathic Gastroparesis
Interventions: NG101, Placebo
First posted: 2020-03-10
Last updated: 2025-08-28
Results first posted: 2025-08-28

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline of Nausea Severity Score	Baseline to Week 12	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.
Secondary	Change From Baseline in Early Satiety Severity Score	Baseline to Week 12	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.
Secondary	Change From Baseline in Postprandial Fullness Severity Score	Baseline to Week 12	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.
Secondary	Change From Baseline in Abdominal Pain Severity Score	Baseline to Week 12	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.
Secondary	Change From Baseline in Discrete Episodes of Vomiting	Baseline to Week 12	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.
Secondary	Change From Baseline in 3-symptom Severity Score	Baseline to Week 12	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.
Secondary	Change From Baseline in 4-symptom Severity Score	Baseline to Week 12	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

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline of Nausea Severity Score	Baseline to Week 12	Per Protocol population included all participants in the Intent-To-Treat Population (all enrolled participants who were randomized) who do not have any major protocol deviations that would affect efficacy as determined by the study team.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Early Satiety Severity Score	Baseline to Week 12		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Postprandial Fullness Severity Score	Baseline to Week 12		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Abdominal Pain Severity Score	Baseline to Week 12		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Discrete Episodes of Vomiting	Baseline to Week 12		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 3-symptom Severity Score	Baseline to Week 12		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 4-symptom Severity Score	Baseline to Week 12		units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline of Nausea Severity Score	NG101 - 5 mg	-3.55	Standard Error 0.331	units on a scale
Change From Baseline of Nausea Severity Score	NG101 - 10 mg	-3.65	Standard Error 0.0348	units on a scale
Change From Baseline of Nausea Severity Score	NG101 - 20 mg	-3.43	Standard Error 0.348	units on a scale
Change From Baseline of Nausea Severity Score	Placebo	-2.83	Standard Error 0.347	units on a scale
Change From Baseline in Early Satiety Severity Score	NG101 - 5 mg	-3.02	Standard Error 0.343	units on a scale
Change From Baseline in Early Satiety Severity Score	NG101 - 10 mg	-3.23	Standard Error 0.360	units on a scale
Change From Baseline in Early Satiety Severity Score	NG101 - 20 mg	-2.64	Standard Error 0.362	units on a scale
Change From Baseline in Early Satiety Severity Score	Placebo	-2.89	Standard Error 0.361	units on a scale
Change From Baseline in Postprandial Fullness Severity Score	NG101 - 5 mg	-2.94	Standard Error 0.373	units on a scale
Change From Baseline in Postprandial Fullness Severity Score	NG101 - 10 mg	-2.96	Standard Error 0.392	units on a scale

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NG101 - 5 mg	40
Overall Study	STARTED	NG101 - 10 mg	41
Overall Study	STARTED	NG101 - 20 mg	40
Overall Study	STARTED	Placebo	40
Overall Study	COMPLETED	NG101 - 5 mg	35
Overall Study	COMPLETED	NG101 - 10 mg	35
Overall Study	COMPLETED	NG101 - 20 mg	31
Overall Study	COMPLETED	Placebo	33
Overall Study	NOT COMPLETED	NG101 - 5 mg	5
Overall Study	NOT COMPLETED	NG101 - 10 mg	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events288

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	NG101 - 5 mg	0	40
other	Anaemia	Blood and lymphatic system disorders	NG101 - 10 mg	1	41
other	Anaemia	Blood and lymphatic system disorders	NG101 - 20 mg	1	40
other	Anaemia	Blood and lymphatic system disorders	Placebo	0	40
other	Palpitations	Cardiac disorders	NG101 - 5 mg	0	40
other	Palpitations	Cardiac disorders	NG101 - 10 mg	0	41
other	Palpitations	Cardiac disorders	NG101 - 20 mg	1	40
other	Palpitations	Cardiac disorders	Placebo	0	40
other	Postural orthostatic tachycardia syndrome	Cardiac disorders	NG101 - 5 mg	0	40
other	Postural orthostatic tachycardia syndrome	Cardiac disorders	NG101 - 10 mg	1	41

1 to 10 of 288Source ClinicalTrials.gov

See all 288 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NG101 - 5 mg	0	40
Total, all-cause mortality	NG101 - 10 mg	0	41
Total, all-cause mortality	NG101 - 20 mg	0	40
Total, all-cause mortality	Placebo	0	40
Total, other adverse events	NG101 - 5 mg	15	40
Total, other adverse events	NG101 - 10 mg	12	41
Total, other adverse events	NG101 - 20 mg	21	40
Total, other adverse events	Placebo	14	40
Total, serious adverse events	NG101 - 5 mg	1	40
Total, serious adverse events	NG101 - 10 mg	0	41

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40367443	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04303195

GET https://conductscience.org/api/trials/v1/NCT04303195/results?page=2

API reference For AI assistants