A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a Glucagon-like Peptide-1 (GLP-1) Agonist

September 2, 2025 updated by: Neurogastrx, Inc.

A Proof-of-Concept, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of Oral NG101 in the Treatment of Side Effects in Healthy Adult Participants Administered a Single Subcutaneous Dose of a Glucagon-Like Peptide 1 Agonist

Adult participants with BMI between 22 - 35 kg/m2 will be enrolled and randomized to receive either NG101 (20 mg twice daily [BID]) or placebo for 5 days beginning on Day 1. On Day 2, all participants will receive a single subcutaneous injection of a Glucagon-like Peptide-1 (GLP-1) agonist (semaglutide). Participants will remain at the clinical research unit for the duration of the treatment period.

The goal of this clinical trial is to evaluate the safety and efficacy of NG101 compared to placebo, when also administered along with a GLP-1 agonist, in the management of gastrointestinal side effects commonly associated with GLP-1 agonists for overweight or obesity. Adverse event information will be collected. Gastrointestinal (GI)-specific questionnaires will be used to capture additional details if GI-related adverse events are reported.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adult
  • Male or female
  • BMI between 22 - 35 kg/m2 at screening

Exclusion Criteria:

  • Presence or history of illness that might confound the results of the study or pose an -
  • History of presence of gastroparesis, gallbladder disease, acute or chronic pancreatitis, or surgery of the abdomen
  • History or presence of Type 1 or Type 2 diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NG101 20 mg BID
NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide
Drug: Semaglutide Injectable Product
Semaglutide 0.5 or 1 mg
Drug: NG101
NG101 20 mg BID
Other Names:
  • metopimazine mesylate
Placebo Comparator: Placebo
Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide
Drug: Placebo
Placebo BID
Drug: Semaglutide Injectable Product
Semaglutide 0.5 or 1 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of GI-related adverse events
Time Frame: 96 hours following GLP-1 agonist injection
Number of days with TEAEs of GI-related adverse events following GLP-1 agonist injection
96 hours following GLP-1 agonist injection
Severity of GI-related adverse events
Time Frame: 96 hours following GLP-1 agonist injection
Moderate and/or severe TEAES of GI-related adverse events following GLP-1 agonist injection
96 hours following GLP-1 agonist injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of TEAEs of GI-related adverse events
Time Frame: 96 hours following GLP-1 agonist injection
Number of TEAEs of GI-related adverse events following GLP-1 agonist injection
96 hours following GLP-1 agonist injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurogastrx, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Actual)

September 4, 2024

Study Completion (Actual)

September 13, 2024

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NG101-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe