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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.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Celerion
Tempe, Arizona, United States
Start Date
June 24, 2024
Primary Completion Date
September 4, 2024
Completion Date
September 13, 2024
Last Updated
September 4, 2025
120
ACTUAL participants
NG101
DRUG
Placebo
DRUG
Semaglutide Injectable Product
DRUG
Lead Sponsor
Neurogastrx, Inc.
NCT06290258
NCT00090662
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07310264