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Completed

NCT Number: NCT06500429

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

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Key information

Conditions

Overweight and Obesity Body Weight Healthy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NG101

Drug

NG101 20 mg BID

Other names: metopimazine mesylate

Placebo

Drug

Placebo BID

Semaglutide Injectable Product

Drug

Semaglutide 0.5 or 1 mg

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Neurogastrx, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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