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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06500429

Enrollment

120

Registered

2024-07-15

Start date

2024-06-24

Completion date

2024-09-13

Last updated

2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Healthy

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

DRUGPlacebo

Placebo BID

DRUGNG101

NG101 20 mg BID

DRUGSemaglutide Injectable Product

Semaglutide 0.5 or 1 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of TEAEs of GI-related adverse events	96 hours following GLP-1 agonist injection	Number of TEAEs of GI-related adverse events following GLP-1 agonist injection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026