GastroparesisPhase 2MOMENTUMNCT05270460

Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis

A Phase 2 study testing PCS12852 in people with Gastroparesis, run by Processa Pharmaceuticals at 9 sites in United States.

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 randomized, double-blind, placebo-controlled study that will compare the effect of 2 different dosage regimens of PCS12852 on gastric emptying time to placebo in both idiopathic gastroparesis (IG) and diabetic gastroparesis (DG) patients. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Gastroparesis
What is being tested?: PCS12852
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 25 participants
Where: 9 sitesUnited States
Study dates: 9 Mar 2022to 6 Oct 2022
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has documented diagnosis of moderate to severe DG or IG according to the ANMS GCSI-DD score during the Screening period (score of >2 on average of the screening days).
Moderate to severe delay in gastric emptying rate as measured by the GEBT at Screening defined as GE half-time (t1/2) ≥ the 80th percentile of normative data as determined by Cairn Diagnostics.
Male or female patients 18 to 80 years of age, inclusive, at baseline.
Has continuous moderate to severe symptoms for gastroparesis (that is, chronic postprandial fullness, abdominal pain, postprandial nausea, vomiting, loss of appetite and/or early satiety) as assessed by the investigator for at least the past 3 months.
Has hemoglobin A1c (BbA1c) < 11%.
Has Body Mass Index range between 18-40.
Women of childbearing potential must use one of the following acceptable methods of contraception throughout the study (1 month prior to Screening through 1 month after last dose of study medication): oral contraceptive medication, IUD, hormonal implants, injectable contraceptive methods, double-barrier methods, or tubal ligation.
Male patients must be willing to use acceptable contraceptive measures such as vasectomy or double-barrier method and refrain from sexual activity with any female who is pregnant or lactating. Female partners of study participants are asked to use acceptable methods of contraception.

Who cannot join

Has acute, severe gastroenteritis and pronounced dehydration in the past 48 hours prior to Screening, chronic parenteral feeding or persistent severe vomiting.
Has known hypersensitivity to Spirulina, egg, milk products or wheat allergens.
Has a known disturbance of small intestinal absorption, exocrine pancreatic function, liver metabolism or pulmonary function.
Has a history of anorexia nervosa or bulimia.
Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
Prior surgery involving any gastrointestinal surgery, including the luminal gastrointestinal (GI) tract (cholecystectomy and appendectomy are permitted if performed >3 months prior to baseline GEBT).

Show all 20Show fewer

Any abdominal or pelvic surgery within the past 3 months.
Known history of the following GI conditions: inflammatory bowel disease; irritable bowel syndrome with diarrhea; or any other active disorder that could explain symptoms in the opinion of the investigator.
Has active diverticulitis, diverticular stricture, and other intestinal strictures.
Currently taking Glucagon-like peptide-1 (GLP-1) agonists, e.g. exenatide, liraglutide, semaglutide or dulaglutide, or pramlintide.
Has severe psychiatric illness (including suicidal tendencies or ideation) or neurological illness.
Use of narcotics/opioids, drugs used to treat gastroparesis within 3 days of the Screening GEBT test.
Clinically significant cardiac disease including but not limited to unstable angina, acute myocardial infarction within 6 months of baseline, and arrhythmia requiring therapy.
Patient has QTc interval ≥ 480 milliseconds on Screening ECG.
History of cerebral hemorrhage, cerebrovascular accident, transient ischemic attack, gastrointestinal bleeding, or retinal hemorrhage within 6 months of baseline.
Patient has active or history of neoplastic disease (except for adequately treated non-invasive basal cell and/or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) within the past 5 years prior to baseline.
Presence of clinically significant medical condition(s) including but not limited to: renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, neurological, psychiatric, substance abuse, and or any other clinically significant disease or disorder, which in the opinion of the investigator, may put the patient at risk due to participation in the study, influence the results of the study, and/or affect the patient's ability to complete the study.
History of or current diagnosis of active tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of the Screening Visit of a positive TB skin test with purified protein derivative with induration ≥ 5 mm, a positive QuantiFERON TB test or positive or borderline T-SPOT [Elispot] test); or positive TB test at Screening. Patients with documented completion of appropriate LTBI treatment would not be excluded and are not required to be tested.
Currently taking known P-gp and BCRP inhibitors or inducers and gastric acid reducing agents. E.g., proton pump inhibitors or H2 receptor antagonists.
Other inclusion/exclusion criteria apply.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Delta Research Partners
Bastrop, Louisiana, 71220
Texas Tech University
El Paso, Texas, 79905
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023
Torrance Clinical Research Institute, Inc.
Lomita, California, 90717
University of Louisville
Louisville, Kentucky, 40202
APF Research, LLC
Miami, Florida, 33135
International Research Associates, LLC
Miami, Florida, 33183
M3 Wake Research
Raleigh, North Carolina, 27612
TriWest Research Associates
San Diego, California, 92108

Other trials in United States

About this study

Official title: A Phase 2A, Placebo-controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by 13C Spirulina GEBT in Patients With Moderate to Severe Gastroparesis

Read the detailed description

A randomized, double-blind, placebo-controlled study that will compare the effect of 2 different dosage regimens of PCS12852 on gastric emptying time to placebo in both idiopathic gastroparesis (IG) and diabetic gastroparesis (DG) patients.

Conditions: Gastroparesis
Being tested: PCS12852, Placebo
Keywords: Idiopathic Gastroparesis, Diabetic Gastroparesis
Medical subject headings: Gastroparesis

What participants receive

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

PCS12852Drug
Also called 5HT4 receptor agonist
PCS12852 oral tablet administered once daily
PlaceboDrug
Placebo comparator oral tablet administered once daily

Study groups in NCT05270460
Study group	Role	What they receive
PCS12852 0.1mg	Experimental	PCS12852 0.1mg tablet Receives: Drug: PCS12852
PCS12852 0.5mg	Experimental	PCS12852 0.5mg tablet Receives: Drug: PCS12852
Placebo	Placebo comparator	Similar in appearance to active study drug Receives: Drug: Placebo

What is being measured

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

Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate
Change from baseline in gastric emptying rate was determined by the AUC by Gastric Emptying Breath Test (GEBT) at Day 28 after administration of PCS12852 or placebo.
Measured: ~28 days
Change in Gastric Emptying Rate From Baseline
Time for 50% gastric emptying (t50) metric assessed by the GEBT
Measured: ~28 days
Concentrations of PCS12852 in Plasma - Cmax
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Measured: Day 1
Concentrations of PCS12852 in Plasma - AUC0-last
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Measured: Day 1
Concentrations of PCS12852 in Plasma - AUC0-last
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Measured: Day 28
Concentrations of PCS12852 in Plasma - Cmax
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Measured: Day 28

Secondary outcomes (4)

Change From Baseline in the ANMS GCSI-DD
Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD). Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.
Measured: Day 7
Change From Baseline in the ANMS GCSI-DD
Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary. Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.
Measured: Day 14
Change From Baseline in the ANMS GCSI-DD
Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary. Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.
Measured: Day 21
Change From Baseline in the ANMS GCSI-DD
Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary. Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.
Measured: Day 28

Timeline

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

9 Mar 20226 Oct 2022

First posted8 Mar 2022
Study start9 Mar 2022
Primary completion29 Sep 2022
Study completion6 Oct 2022

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05270460
Sponsor's protocol ID: PCS12852-GP-01
Acronym: MOMENTUM
Status last verified: Jun 2023
First submitted: 25 Feb 2022
Last updated: 22 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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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Recruiting
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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2A, Placebo-controlled, Randomized, Dose Response Study of the Safety, Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate Assessed by 13C Spirulina GEBT in Patients With Moderate to Severe Gastroparesis
ClinicalTrials.gov ID: NCT05270460
Acronym / sponsor ID: MOMENTUM / PCS12852-GP-01
Conditions: Gastroparesis
Keywords: Idiopathic Gastroparesis, Diabetic Gastroparesis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Processa PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 9 Mar 2022 (actual)
Primary completion: 29 Sep 2022 (actual)
Study completion: 6 Oct 2022 (actual)
First posted: 8 Mar 2022 (actual)
Results: Posted 21 Jul 2023

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
PCS12852 0.1mg	Experimental	Drug: PCS12852PCS12852 0.1mg tablet
PCS12852 0.5mg	Experimental	Drug: PCS12852PCS12852 0.5mg tablet
Placebo	Placebo comparator	Drug: PlaceboSimilar in appearance to active study drug

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Has documented diagnosis of moderate to severe DG or IG according to the ANMS GCSI-DD score during the Screening period (score of >2 on average of the screening days).
Moderate to severe delay in gastric emptying rate as measured by the GEBT at Screening defined as GE half-time (t1/2) ≥ the 80th percentile of normative data as determined by Cairn Diagnostics.
Male or female patients 18 to 80 years of age, inclusive, at baseline.
Has continuous moderate to severe symptoms for gastroparesis (that is, chronic postprandial fullness, abdominal pain, postprandial nausea, vomiting, loss of appetite and/or early satiety) as assessed by the investigator for at least the past 3 months.
Has hemoglobin A1c (BbA1c) < 11%.

Key exclusion criteria (20 listed)

Has acute, severe gastroenteritis and pronounced dehydration in the past 48 hours prior to Screening, chronic parenteral feeding or persistent severe vomiting.
Has known hypersensitivity to Spirulina, egg, milk products or wheat allergens.
Has a known disturbance of small intestinal absorption, exocrine pancreatic function, liver metabolism or pulmonary function.
Has a history of anorexia nervosa or bulimia.
Previous history of bezoars (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).

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
PCS12852Also: 5HT4 receptor agonistPCS12852 oral tablet administered once daily	Drug	PCS12852 0.1mg, PCS12852 0.5mg
PlaceboPlacebo comparator oral tablet administered once daily	Drug	Placebo

Primary outcome

Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate
Time frame: ~28 days
Change from baseline in gastric emptying rate was determined by the AUC by Gastric Emptying Breath Test (GEBT) at Day 28 after administration of PCS12852 or placebo.
Change in Gastric Emptying Rate From Baseline
Time frame: ~28 days
Time for 50% gastric emptying (t50) metric assessed by the GEBT
Concentrations of PCS12852 in Plasma - Cmax
Time frame: Day 1
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Concentrations of PCS12852 in Plasma - AUC0-last
Time frame: Day 1
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Concentrations of PCS12852 in Plasma - AUC0-last
Time frame: Day 28
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
Concentrations of PCS12852 in Plasma - Cmax
Time frame: Day 28
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

4 secondary outcomes

Change From Baseline in the ANMS GCSI-DD
Time frame: Day 7
Change From Baseline in the ANMS GCSI-DD
Time frame: Day 14
Change From Baseline in the ANMS GCSI-DD
Time frame: Day 21
Change From Baseline in the ANMS GCSI-DD
Time frame: Day 28

Results and safety

Results posted to the registry on 21 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PCS12852 0.1mg	9	9
PCS12852 0.5mg	8	6
Placebo	8	8

Primary outcome: Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate

Time frame: ~28 days. Least squares mean (Standard Error). Unit: kPCD/minutes

Measure	PCS12852 0.1mg n = 9	PCS12852 0.5mg n = 6	Placebo n = 8
Value	267.12 (708.056)	283.09 (871.664)	221.74 (738.728)

PCS12852 0.1mg vs PCS12852 0.5mg vs Placebo: p <0.05, ANCOVA

Population analysed: The change from baseline to Day 28 in AUC was analyzed using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and gastroparesis type (idiopathic gastroparesis \[IG\] or diabetic gastroparesis \[DG\]) and the baseline value as a continuous covariate. Only patients with a baseline and Day 28 value were included in the analysis. The parameters listed are the best comparison of the breath test as opposed to individual timepoints.

Primary outcome: Change in Gastric Emptying Rate From Baseline

Time frame: ~28 days. Least squares mean (Standard Error). Unit: Minutes

Measure	PCS12852 0.1mg n = 9	PCS12852 0.5mg n = 6	Placebo n = 8
Value	-4.89 (12.320)	-26.64 (14.971)	-11.15 (12.365)

PCS12852 0.1mg vs PCS12852 0.5mg vs Placebo: p <0.05, ANCOVA

Population analysed: The change from baseline to Day 28 using the t50 metric was analyzed using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and gastroparesis type (idiopathic gastroparesis \[IG\] or diabetic gastroparesis \[DG\]) and the baseline value as a continuous covariate. Only patients with a baseline and Day 28 value were included in the analysis. The parameters listed are the best comparison of the breath test as opposed to individual timepoints.

Primary outcome: Concentrations of PCS12852 in Plasma - Cmax

Time frame: Day 1. Mean (Standard Deviation). Unit: ng/mL

Measure	PCS12852 0.1mg n = 7	PCS12852 0.5mg n = 7
Value	0.12211 (0.039216)	0.59986 (0.329187)

PCS12852 0.1mg vs PCS12852 0.5mg: p <0.05, Regression, Linear

Population analysed: PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.

Primary outcome: Concentrations of PCS12852 in Plasma - AUC0-last

Time frame: Day 1. Mean (Standard Deviation). Unit: h*ng/mL

Measure	PCS12852 0.1mg n = 7	PCS12852 0.5mg n = 7
Value	0.6331 (0.27524)	3.0612 (1.58834)

PCS12852 0.1mg vs PCS12852 0.5mg: p <0.05, Regression, Linear

Population analysed: PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCS12852 0.1mg	0 of 9 (0%)	0 of 9 (0%)	0 of 9
PCS12852 0.5mg	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Placebo	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Richard McCallum, MD principal investigator

Texas Tech University Health Center

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PCS12852 in people with Gastroparesis, run by Processa Pharmaceuticals at 9 sites in United States.

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 20 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 22 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 9 sites in United States. 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 21 Jul 2023). 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 Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate (time frame: ~28 days). The study lists 6 primary outcomes in all. 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 NCT05270460.

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 22 Oct 2026.