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NCT06500429CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 4 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
120 (actual)
First submitted
8 Jul 2024
Start date
24 Jun 2024
Primary completion date
4 Sept 2024
Lead sponsor
Neurogastrx, Inc.
Diseases
Obesity
NCT number
NCT06500429

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 120
  • From 24 Jun 2024 to the primary completion date, 4 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

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

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Celerion
Coordinator of this site? Confirm its status
TempeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.