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

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.

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