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Semaglutide

Ozempic, Rybelsus, Wegovy

Quick Stats
Studies 78
Trials 100
Completed PHASE2 INTERVENTIONAL NCT06500429

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: NG101
Type: DRUG
Description: NG101 20 mg BID
Name: Placebo
Type: DRUG
Description: Placebo BID
Name: Semaglutide Injectable Product
Type: DRUG
Description: Semaglutide 0.5 or 1 mg

Primary Outcomes

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

Trial Information

NCT ID

NCT06500429

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Neurogastrx, Inc.

Last Updated

December 15, 2025