CompletedNCT05621811MOVE-ITUpdated Oct 7, 2026Results posted

Different Doses of Naronapride vs. Placebo in Gastroparesis

A Phase 2 interventional study of Naronapride and Placebo in Gastroparesis, sponsored by Dr. Falk Pharma GmbH. Completed at 24 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Dr. Falk Pharma GmbH · Phase 2, Interventional, and Treatment

Updated Oct 7, 2026Results postedStudy documents posted+2 moreGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 328
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This is a double-blind, randomized, multicenter, placebo-controlled, comparative phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 10, 20, or 40 mg Naronapride vs. placebo for the treatment of patients with Gastroparesis.

Conditions studied

Gastroparesis

Browse trials for

Keywords

stomach
diabetes mellitus

In context

Gastroparesis

323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.

This study's enrollment of 328 is above the median of 42 across 215 interventional studies indexed under Gastroparesis.

Browse Gastroparesis studies →

Lead sponsor

Dr. Falk Pharma GmbH is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Browse Dr. Falk Pharma GmbH studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Men and women between ≥18 and ≤75 years of age,
(BMI) ≥16 and \<35 kg/m2 ,
History of idiopathic or diabetic gastroparesis cardinal symptoms (e.g., nausea, vomiting, early satiety, postprandial fullness, bloating or upper abdominal pain) for ≥3 months,
Evidence of delayed gastric emptying by 13C-spirulina gastric emptying breath test (GEBT) for solids with gastric emptying T1/2 ≥ 85.33 minutes (≥ 90th percentile of normative data) during the screening phase,
Average weekly total symptom score of the ANMS GCSI-DD ≥2.0 based on the daily symptom scores recorded for at least 5 of 7 consecutive days in the week prior to Baseline,
Participants with a type I or type II diabetes mellitus diagnosis must have a controlled diabetes mellitus defined as ≤11% under stable antidiabetic medication,
Exclusion of any mechanical and/or anatomical obstructions, stenosis, structural diseases, or gastric ulcers by upper gastrointestinal endoscopy during screening phase (previous endoscopic results within 12 months are acceptable, if no relevant changes in patient's disease status occurred since that time),
No evidence of intestinal stenosis as determined by an imaging technique (i.e., either abdominal sonography, Magnetic resonance imaging [MRI] or imaging by computed tomography [CT] during screening phase (previous MRI/CT imaging or sonography results within 12 months are acceptable, if no relevant changes occurred in patient's disease status since that time),

Exclusion criteria

Exclusion Criteria:

History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal , colectomy,
Intrapyloric botulinum toxin injection within 12 months,
Gastric stimulator implant,
Known secondary causes of gastroparesis including but not limited to Parkinson's Disease, cancer, or connective tissue diseases,

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 328 participants (actual)

Study arms

Experimental
Naronapride 10 mg
Drug: Naronapride
Experimental
Naronapride 20 mg
Drug: Naronapride
Experimental
Naronapride 40 mg
Drug: Naronapride
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugNaronapride
Naronapride is a gut lumen active, bifunctional 5HT-4 agonist//D2 antagonist
DrugPlacebo
Placebo

What researchers measure

Primary outcomes

Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary Total Score at Week 12
ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD core symptom score (total score) included score of nausea, vomiting, early satiety, upper abdominal pain, and postprandial fullness. The severity scores of these symptoms range from 0 (none) to 4 (very severe). For vomiting, the actual number of vomiting episodes was recorded by the participants and capped at 4. Thus, the maximum daily score was 4. The ANMS GCSI-DD core symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. A negative change from baseline indicates improvement. The weekly ANMS GCSI-DD score will be calculated as the average of the available daily scores within the 7-day period. Mixed-effects Model for Repeated Measures (MMRM) was used for the analysis.
Time frame: Baseline and Week 12

Results

Posted Oct 7, 2026

Participant flow

Participants with symptomatic idiopathic or diabetic gastroparesis took part in the study at 71 investigative sites from 03 Jan 2023 to 04 Sep 2025.

Participant flow — Overall Study
Milestone	Naronapride 10 mg	Naronapride 20 mg	Naronapride 40 mg	Placebo
Started	83	82	85	85
Safety analysis set	83	81	79	85
Full analysis set	83	80	80	85
Completed	67	63	64	79
Not completed	16	19	21	6

Outcome measures

PrimaryChange in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary Total Score at Week 12

ANMS GCSI-DD is a patient-reported outcome instrument for a symptom-based clinical trial endpoint in gastroparesis. The ANMS GCSI-DD core symptom score (total score) included score of nausea, vomiting, early satiety, upper abdominal pain, and postprandial fullness. The severity scores of these symptoms range from 0 (none) to 4 (very severe). For vomiting, the actual number of vomiting episodes was recorded by the participants and capped at 4. Thus, the maximum daily score was 4. The ANMS GCSI-DD core symptom score ranged from 0 to 4 with higher scores reflecting greater symptom severity. A negative change from baseline indicates improvement. The weekly ANMS GCSI-DD score will be calculated as the average of the available daily scores within the 7-day period. Mixed-effects Model for Repeated Measures (MMRM) was used for the analysis.

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · Score on a scale

Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary Total Score at Week 12
Score on a scale	Naronapride 10 mg	Naronapride 20 mg	Naronapride 40 mg	Placebo
Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary Total Score at Week 12	-1.244 ± 0.1	-1.512 ± 0.102	-1.452 ± 0.100	-1.106 ± 0.095

Adverse events

Collected over From study start until 4 weeks after end of treatment (up to approximately 16 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Naronapride 10 mg	0/83 (0%)	4/83 (4.8%)	27/83 (32.5%)
Naronapride 20 mg	0/81 (0%)	4/81 (4.9%)	30/81 (37%)
Naronapride 40 mg	0/79 (0%)	4/79 (5.1%)	42/79 (53.2%)
Placebo	0/85 (0%)	1/85 (1.2%)	14/85 (16.5%)

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	Naronapride 10 mg	Naronapride 20 mg	Naronapride 40 mg	Placebo
Diverticulitis intestinal perforatedInfections and infestations	0/83	0/81	1/79	0/85
InfluenzaInfections and infestations	0/83	0/81	1/79	0/85
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/83	0/81	1/79	0/85
Papillary thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/83	0/81	1/79	0/85
Patella fractureInjury, poisoning and procedural complications	0/83	0/81	1/79	0/85
BronchitisInfections and infestations	0/83	1/81	0/79	0/85
Vascular procedure complicationInjury, poisoning and procedural complications	0/83	1/81	0/79	0/85
AnaemiaBlood and lymphatic system disorders	0/83	1/81	0/79	0/85
Rash pruriticSkin and subcutaneous tissue disorders	0/83	1/81	0/79	0/85
Appendicitis perforatedInfections and infestations	1/83	0/81	0/79	0/85

Most frequent other events

Most frequent other events
Event	Naronapride 10 mg	Naronapride 20 mg	Naronapride 40 mg	Placebo
DiarrhoeaGastrointestinal disorders	6/83	13/81	18/79	4/85
HeadacheNervous system disorders	8/83	3/81	11/79	3/85
NasopharyngitisInfections and infestations	3/83	7/81	4/79	2/85
NauseaGastrointestinal disorders	3/83	5/81	2/79	3/85
Abdominal pain upperGastrointestinal disorders	5/83	0/81	3/79	2/85
Abdominal painGastrointestinal disorders	2/83	2/81	4/79	0/85

Baseline characteristics

Baseline Characteristics analysed in Safety Analysis Set (SAF)

Age, Continuous
Age, Continuous(years)	Naronapride 10 mg	Naronapride 20 mg	Naronapride 40 mg	Placebo	Total
Mean	49.6 ± 15.0	50.9 ± 14.4	50.4 ± 15.4	53.4 ± 13.9	51.1 ± 14.7

Sex: Female, Male
Sex: Female, Male(Participants)	Naronapride 10 mg	Naronapride 20 mg	Naronapride 40 mg	Placebo	Total
Female	69	63	60	70	262
Male	14	18	19	15	66

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Naronapride 10 mg	Naronapride 20 mg	Naronapride 40 mg	Placebo	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	4	1	2	2	9
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	1	0	1	0	2
White	77	80	73	81	311
More than one race	0	0	0	0	0
Unknown or Not Reported	1	0	3	2	6

ANMS GCSI-DD core symptom score
ANMS GCSI-DD core symptom score(Score on a scale)	Naronapride 10 mg	Naronapride 20 mg	Naronapride 40 mg	Placebo	Total
Mean	2.450 ± 0.388	2.429 ± 0.339	2.462 ± 0.453	2.402 ± 0.396	2.435 ± 0.394

Study locations

24 sites

Dr Falk Investigational Site
Chula Vista, California 91910, United States
Dr Falk Investigational Site
Lomita, California 90717, United States
Dr Falk Investigational Site
Clearwater, Florida 33756, United States
Dr Falk Investigational Site
Doral, Florida 33126, United States
Dr Falk Investigational Site
Hollywood, Florida 33021, United States
Dr Falk Investigational Site
Maitland, Florida 32751, United States
Dr Falk Investigational Site
Miami, Florida 33144, United States
Dr Falk Investigational Site
Miami, Florida 33183, United States
Dr Falk Investigational Site
Viera, Florida 32940, United States
Dr Falk Investigational Site
Kansas City, Kansas 66160, United States
Dr Falk Investigational Site
Topeka, Kansas 66606, United States
Dr Falk Investigational Site
Crestview Hills, Kentucky 41017, United States
Dr Falk Investigational Site
Houma, Louisiana 70363, United States
Dr Falk Investigational Site
Marrero, Louisiana 70072, United States
Dr Falk Investigational Site
Flint, Michigan 48439, United States
Dr Falk Investigational Site
Flint, Michigan 48503, United States
Dr Falk Investigational Site
New York, New York 10033, United States
Dr Falk Investigational Site
Cleveland, Ohio 44195, United States
Dr Falk Investigational Site
Tulsa, Oklahoma 74104, United States
Dr Falk Investigational Site
Philadelphia, Pennsylvania 19087, United States
Dr Falk Investigational Site
Cordova, Tennessee 38018, United States
Dr Falk Investigational Site
Nashville, Tennessee 37211, United States
Dr Falk Investigational Site
Harlingen, Texas 78550, United States
University of Leuven
Leuven, Belgium

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Oct 7, 2024

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Aug 2025, 31 months.

Results were first posted in Oct 2026, 1 year 1 month after primary completion.

Of 20 phase 2 interventional studies under Gastroparesis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's 31 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 3, 2022
First posted: Nov 18, 2022
StartActual: Jan 3, 2023
Primary completionActual: Aug 12, 2025
CompletionActual: Sep 4, 2025
Results first posted: Oct 7, 2026
Last update: Oct 7, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Results

Results posted

posted Oct 7, 2026

Sites

2 sites added

Show 2 added (2 United States)

Dr Falk Investigational Site · Kansas City, United States
Dr Falk Investigational Site · Cleveland, United States

Oct 7, 2026

Primary outcomes

1 edited

What changed in the outcomes

EditedChange in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary ~~total score from baseline to week~~Total Score at Week 12Time frame: ~~12 weeks~~ → Baseline and Week 12

Oct 7, 2026

Documents

Protocol and statistical analysis plan ↗ posted

Oct 7, 2026

Show all 1 update

Oct 7, 2026
Results posted
Documents Protocol and statistical analysis plan ↗ posted
2 sites added
Show 2 added (2 United States)
- Dr Falk Investigational Site · Kansas City, United States
- Dr Falk Investigational Site · Cleveland, United States
Primary outcomes 1 edited
What changed in the outcomes
- EditedChange in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary ~~total score from baseline to week~~Total Score at Week 12Time frame: ~~12 weeks~~ → Baseline and Week 12
+ 4 other changes: index terms, identifiers, arm descriptions and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05621811
Lead sponsor: Dr. Falk Pharma GmbH
Responsible party: Sponsor
First posted: Nov 18, 2022
Start date: Jan 3, 2023
Primary completion: Aug 12, 2025
Completion: Sep 4, 2025
Results posted: Oct 7, 2026
Last update: Oct 7, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: ATI 7505

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Different Doses of Naronapride vs. Placebo in Gastroparesis

Study summary

Conditions studied

Browse trials for

Keywords

In context

Gastroparesis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Study documents

Individual participant data

Timeline

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria