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

NCT06500429 | Completed Phase 2 FDA Drug

• 1 other identifier: NG101-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity; Healthy

Outcome Measures

Primary Outcomes (2)

• Duration of GI-related adverse events

  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

  Moderate and/or severe TEAES of GI-related adverse events following GLP-1 agonist injection

  96 hours following GLP-1 agonist injection

Secondary Outcomes (1)

• Number of TEAEs of GI-related adverse events

  96 hours following GLP-1 agonist injection

Study Arms (2)

NG101 20 mg BID

EXPERIMENTAL

NG101 (metopimazine mesylate) 20 mg capsule BID + single SC dose of 0.5 or 1 mg semaglutide

Drug: NG101; Drug: Semaglutide Injectable Product

Placebo

PLACEBO COMPARATOR

Placebo capsule BID + single SC dose of 0.5 or 1 mg semaglutide

Drug: Placebo; Drug: Semaglutide Injectable Product

Interventions

NG101 DRUG

NG101 20 mg BID

Also known as: metopimazine mesylate

NG101 20 mg BID

Placebo DRUG

Placebo BID

Placebo

Semaglutide Injectable Product DRUG

Semaglutide 0.5 or 1 mg

NG101 20 mg BID; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurogastrx, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: June 24, 2024
• Primary Completion: September 4, 2024
• Study Completion: September 13, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)