GastroparesisPhase 2MOVE-ITNCT05621811

Different Doses of Naronapride vs. Placebo in Gastroparesis

A Phase 2 study testing Naronapride in people with Gastroparesis, run by Dr. Falk Pharma GmbH at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastroparesis
What is being tested?: Naronapride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 328 participants
Where: 24 sitesin 2 countries
Study dates: 3 Jan 2023to 4 Sep 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women between ≥18 and ≤75 years of age,
Body Mass Index (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 HbA1c ≤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),

Who cannot join

History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, 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,

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

United States23 sites

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

Other trials in United States

Belgium1 site

University of Leuven
Leuven

Other trials in Belgium

About this study

Official title: Double-blind, Randomised, Placebo-controlled, Dose-finding Phase IIb Trial to Evaluate the Efficacy, Safety, and Tolerability of a 12-week-treatment With Naronapride in Adult Participants With at Least Moderate Idiopathic or Diabetic Gastroparesis

Conditions: Gastroparesis
Being tested: Naronapride, Placebo
Keywords: stomach, diabetes mellitus
Medical subject headings: Gastroparesis, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05621811
Study group	Role	What they receive
Naronapride 10 mg	Experimental	Not described Receives: Drug: Naronapride
Naronapride 20 mg	Experimental	Not described Receives: Drug: Naronapride
Naronapride 40 mg	Experimental	Not described Receives: Drug: Naronapride
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 20234 Sep 2025

First posted18 Nov 2022
Study start3 Jan 2023
Primary completion12 Aug 2025
Study completion4 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GastroparesisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05621811
Sponsor's protocol ID: NAT-19/GPX
Other IDs: 2023-510195-31-00, 2023
Acronym: MOVE-IT
Status last verified: Apr 2026
First submitted: 3 Nov 2022
Last updated: 7 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
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All Gastroparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Randomised, Placebo-controlled, Dose-finding Phase IIb Trial to Evaluate the Efficacy, Safety, and Tolerability of a 12-week-treatment With Naronapride in Adult Participants With at Least Moderate Idiopathic or Diabetic Gastroparesis
ClinicalTrials.gov ID: NCT05621811
Acronym / sponsor ID: MOVE-IT / NAT-19/GPX
Conditions: Gastroparesis
Keywords: stomach, diabetes mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 328 participants (actual)
Lead sponsor: Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
Study start: 3 Jan 2023 (actual)
Primary completion: 12 Aug 2025 (actual)
Study completion: 4 Sep 2025 (actual)
First posted: 18 Nov 2022 (actual)
Results: Posted 7 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Naronapride 10 mg	Experimental	Drug: Naronapride
Naronapride 20 mg	Experimental	Drug: Naronapride
Naronapride 40 mg	Experimental	Drug: Naronapride
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Men and women between ≥18 and ≤75 years of age,
Body Mass Index (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,

Key exclusion criteria (4 listed)

History of major gastrointestinal surgery such as gastric bypass, anti-reflux surgery, gastric per oral endoscopic myotomy (G-POEM), gastrointestinal malignancy, 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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NaronaprideNaronapride is a gut lumen active, bifunctional 5HT-4 agonist//D2 antagonist	Drug	Naronapride 10 mg, Naronapride 20 mg, Naronapride 40 mg
PlaceboPlacebo	Drug	Placebo

Primary outcome

Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary Total Score at Week 12
Time frame: Baseline and 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.

Results and safety

Results posted to the registry on 7 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naronapride 10 mg	83	67
Naronapride 20 mg	82	63
Naronapride 40 mg	85	64
Placebo	85	79

Primary outcome: Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary Total Score at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: Score on a scale

Measure	Naronapride 10 mg n = 83	Naronapride 20 mg n = 80	Naronapride 40 mg n = 80	Placebo n = 85
Value	-1.244 (0.1)	-1.512 (0.102)	-1.452 (0.100)	-1.106 (0.095)

Population analysed: FAS, defined according to intention-to-treat (ITT) principle, included all randomized participants who received at least one dose of IMP, consisted of the 328 randomized participants who received at least one dose of the IMP (analyzed as randomized).

Adverse events

Time frame: From study start until 4 weeks after end of treatment (up to approximately 16 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naronapride 10 mg	4 of 83 (4.8%)	27 of 83 (32.5%)	0 of 83
Naronapride 20 mg	4 of 81 (4.9%)	30 of 81 (37%)	0 of 81
Naronapride 40 mg	4 of 79 (5.1%)	42 of 79 (53.2%)	0 of 79
Placebo	1 of 85 (1.2%)	14 of 85 (16.5%)	0 of 85

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Gastroparesis

Recruiting
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RecruitingObservational study
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Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Not yet recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naronapride in people with Gastroparesis, run by Dr. Falk Pharma GmbH at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index - Daily Diary Total Score at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05621811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.