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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
NG101 20 mg BID
Placebo BID
Semaglutide 0.5 or 1 mg
Celerion
Tempe, Arizona, United States
Duration of GI-related adverse events
Number of days with TEAEs of GI-related adverse events following GLP-1 agonist injection
Time frame: 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
Time frame: 96 hours following GLP-1 agonist injection
Number of TEAEs of GI-related adverse events
Number of TEAEs of GI-related adverse events following GLP-1 agonist injection
Time frame: 96 hours following GLP-1 agonist injection
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